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PROGENICS PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2017 FINANCIAL RESULTS AND BUSINESS UPDATE

On November 2, 2017 Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) reported financial results and provided a business update for the third quarter of 2017 (Press release, Progenics Pharmaceuticals, NOV 2, 2017, View Source [SID1234521488]).

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“The recent completion of our NDA submission for AZEDRA represents a major achievement for our growing company,” said Mark Baker, Chief Executive Officer of Progenics. “AZEDRA offers a potentially transformative therapy for metastatic pheochromocytoma and paraganglioma patients who have no treatment options in the U.S. for this devastating condition. We are continuing to build the necessary team and infrastructure to support a rapid commercial launch of this important therapy following a potential approval.”

Third Quarter and Recent Key Business Highlights

AZEDRA, Ultra-Orphan Radiotherapeutic Candidate

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New Drug Application (NDA) for AZEDRA (iobenguane I 131) Submitted to the U.S. Food and Drug Administration (FDA) on October 31st
As announced earlier today, Progenics has submitted the NDA for AZEDRA in patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, rare neuroendocrine tumors for which there are currently no approved treatment options in the United States. The NDA remains subject to FDA regulatory review and approval. AZEDRA holds Breakthrough Therapy and Orphan Drug statuses, as well as Fast Track designation.

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Multiple Presentations of Additional Data from Phase 2b Trial of AZEDRA
Progenics has recently presented the positive results from its pivotal Phase 2b study evaluating AZEDRA at the 5th International Symposium on Pheochromocytoma and Paraganglioma (ISP), the North American Neuroendocrine Tumor Society (NANETS) 2017 Annual Symposium, and the 30th Annual Congress of the European Association of Nuclear Medicine (EANM). The Phase 2b trial met the primary endpoint evaluating the proportion of metastatic pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medications for at least six months. The results further demonstrated that sustained reduction of antihypertensive medications was positively correlated with favorable tumor responses, including radiographic tumor responses, tumor biomarker response and overall survival. AZEDRA was shown to be safe and generally well tolerated.

Progenics Announces Third Quarter 2017 Financial Results
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PSMA-Targeted Prostate Cancer Pipeline

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Progress Continues for Clinical Studies of 1404, PyL and 1095
Progenics continues to enroll patients in: the Phase 3 trial of 1404, a SPECT/CT imaging agent; the Phase 2/3 study of PyL, a PET/CT imaging agent; and the Phase 1 open-label dose escalation study of 1095, a radiotherapeutic that selectively binds to PSMA.

RELISTOR, Treatment for Opioid-Induced Constipation (partnered with Valeant Pharmaceuticals International, Inc.)

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Third Quarter 2017 RELISTOR Net Sales of $17.1 Million
The third quarter 2017 sales, as reported to Progenics by its partner Valeant, translated to $2.6 million in royalty revenue for Progenics for the quarter. Oral RELISTOR prescriptions increased 40% over the preceding quarter.

Third Quarter 2017 Financial Results

Third quarter revenue totaled $2.7 million, down from $53.9 million in the third quarter of 2016, reflecting RELISTOR royalty income of $2.6 million compared to $3.3 million in the corresponding period of 2016. The prior year period included milestone revenue of $50.0 million for the approval of RELISTOR oral tablets as well as a non-recurring favorable sales return adjustment included in Valeant’s reported net sales of RELISTOR.

Third quarter research and development expenses increased by $0.5 million compared to the corresponding prior year period, resulting primarily from higher clinical trial costs for PyL, partially offset by lower manufacturing scale-up costs for 1095. Third quarter general and administrative expenses decreased by $1.3 million compared to the corresponding prior year period, which included an accrual for litigation with a former employee. Partially offsetting this decrease were higher costs associated with building commercial capabilities in preparation for a potential AZEDRA approval and launch. For the three months ended September 30, 2017, Progenics recognized interest expense of $1.0 million related to the RELISTOR royalty-backed loan.

Net loss attributable to Progenics for the third quarter was $15.4 million, or $0.22 per diluted share, compared to net income of $36.3 million, or $0.52 per diluted share, in the corresponding 2016 period. Progenics ended the third quarter with cash and cash equivalents of $98.3 million, a decrease of $40.6 million compared to cash and cash equivalents as of December 31, 2016.

Conference Call and Webcast

Progenics will review third quarter financial results in a conference call today at 8:30 a.m. ET. To participate, please dial (877) 250-8889 (domestic) or (720) 545-0001 (international) and reference conference ID 5589567. A live webcast will be available in the Media Center of the Progenics website, www.progenics.com, and a replay will be available for two weeks.

Genocea Reports Third Quarter 2017 Financial Results

On November 2, 2017 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported financial results for the third quarter of 2017 and announced upcoming data presentations at a leading immuno-oncology conference (Press release, Genocea Biosciences, NOV 2, 2017, View Source [SID1234521478]).

“We believe our proprietary ATLASTM technology sets us apart among developers of neoantigen cancer vaccines, as it offers a potential solution to one of the most significant challenges in the field – namely, identifying true neoantigens for those vaccines from up to thousands of potential candidates,” said Chip Clark, president and chief executive officer of Genocea. “ATLAS uses a patient’s own T cells to identify, rather than predict, which of the many personal mutations found in cancerous tumors are true neoantigens, which we believe will enable us to develop more immunogenic and efficacious cancer vaccines. Our upcoming data presentations at the SITC (Free SITC Whitepaper) Annual Meeting continue to support the potential of ATLAS in neoantigen identification for personalized vaccines, including our lead program, GEN-009, for which we expect to file an IND application early next year.”

GEN-009 Progress
GEN-009 is a personalized vaccine consisting of adjuvanted synthetic long peptides of true neoantigens identified by ATLAS.

The company expects to file an Investigational New Drug (IND) application in early 2018.
Genocea plans to initiate a Phase 1 clinical trial in patients with a range of tumor types in the first half of 2018, and expects to report initial immunogenicity data in the first half of 2019.
Upcoming Scientific Presentations
Genocea announced today that it will present three posters at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting taking place November 8 to 12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

Poster #430 entitled “Neoantigen identification using ATLAS across multiple tumor types highlights limitations of prediction algorithms,” will be presented during the session on Personalized Vaccines and Technologies/Personalized Medicine on Saturday, November 11, 2017,
Poster #8 entitled “T cell response profiling in colorectal carcinoma patients reveals an enrichment in responses to specific tumor-associated antigens,” and
Poster #28 entitled “Profiling of T cell responses to tumor-associated antigens in lung cancer patients treated with checkpoint inhibitors,” will both be presented during the session on Biomarkers and Immune Monitoring on Saturday, November 11, 2017.
Corporate Update
Following its announced restructuring at the end of the third quarter, Genocea continues to explore, alongside its advisors, strategic alternatives for GEN-003, the company’s Phase 3-ready investigational immunotherapy to treat the large patient population infected with genital herpes, many of whom are dissatisfied with their current treatment options.

Financial Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the middle of 2018.

Third-Quarter 2017 Financial Results

Cash Position: Cash and cash equivalents as of September 30, 2017 were $22.0 million compared to $35.2 million as of June 30, 2017.
Restructuring: A corporate restructuring was implemented following the Company’s strategic shift to immuno-oncology, resulting in a charge of approximately $1.1 million for employee severance, benefits, and related costs. These amounts will be paid in the fourth quarter of 2017. In addition, Genocea incurred approximately $0.5 million of expense due to contract termination clauses that the Company anticipates will result in future cash payments and approximately $1.0 million in non-cash asset impairment charges.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2017 increased $1.3 million, to $10.2 million from the same period in 2016. The increase was primarily driven by higher external manufacturing-related expenses and increases in compensation to support both the clinical drug supply and clinical trial planning activities in support of the previously planned GEN-003 Phase 3 program, partially offset by reduced clinical costs, due to timing of activities in support of clinical trials. Spending increases on Genocea’s immuno-oncology and cancer vaccine programs were driven primarily by increased manufacturing and compensation, consulting and professional services in anticipation of Genocea’s expected filing of an IND application for GEN-009 in the first quarter of 2018. Increased spending on these programs was offset by lower costs on infectious disease programs previously discontinued in 2016.
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2017 were $3.8 million, compared to $3.6 million for the same period in 2016, reflecting marginal increases in consulting and professional services offset by reductions in depreciation expense, with all other expenditures across various activities remaining consistent with the same quarter in the prior year.
Net Loss: Net loss was $16.9 million for the quarter ended September 30, 2017, compared to a net loss of $12.8 million for the same period in 2016.
Conference Call
Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers and referencing the conference ID number 95267931. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days.

Evotec AG to report first nine-month 2017 results on 08 November 2017

On November 2, 2017 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first nine months of 2017 on Wednesday, 08 November 2017 (Press release, Evotec, NOV 2, 2017, View Source [SID1234521477]).

The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details
Date: Wednesday, 08 November 2017
Time: 02.00 pm CET (01.00 pm GMT/08.00 am EST)

From Germany: +49 69 22 22 29 043
From France: +33 170 750 705
From Italy: +39 02 3601 3806
From UK: +44 20 3009 2452
From USA: +1 855 402 7766
Access Code: 37969784#

A simultaneous slide presentation for participants dialling in via phone is available at http://www.audio-webcast.com/, password: evotec1117.

Webcast details
To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.
A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 22 22 33 985 (Germany) or +44 20 3426 2807 (UK) and in the USA by dialling +1 866 535 8030. The access code is 654573#. The on-demand version of the webcast will be available on our website: View Source

Asterias Biotherapeutics to Report Third Quarter Results on November 14, 2017

On November 2, 2017 Asterias Biotherapeutics, Inc. (NYSE MKT:AST), a biotechnology company focused on the emerging field of regenerative medicine, reported that it will release third quarter 2017 financial and operational results on Tuesday, November 14, 2017 after the close of the U.S. financial markets.

The Company will host a conference call and webcast on November 14, 2017 at 4:30 p.m. Eastern / 1:30 p.m. For both “listen-only” participants and those participants who wish to take part in the question-and-answer session, the call can be accessed by dialing 877-830-2645 (U.S./Canada) or 785-424-1791 (international) five minutes prior to the start of the call and providing the Conference ID 8579194. To access the live webcast, go to View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by dialing 888-203-1112 (U.S./Canada) or 719-457-0820 (international) and providing the Conference ID 8579194. Additionally, the archived webcast will be available at View Source

Aradigm Announces Third Quarter 2017 Financial Results

On November 2, 2017 Aradigm Corporation (NASDAQ: ARDM) (the “Company”) reported financial results for the third quarter and nine months ended September 30, 2017 (Press release, Aradigm, NOV 2, 2017, View Source [SID1234521472]).

The Company recorded $2.7 million in revenue in the third quarter of 2017 compared with $50,000 in revenue in the third quarter of 2016. The Company recognized $2.7 million in contract revenue – related party, $6,000 in government contract revenue and $13,000 in government grant revenue for the third quarter of 2017, as compared to $40,000 in contract revenue – related party and $10,000 in government grant revenue for the third quarter of 2016. For the third quarter of 2017, the Company recorded $1.3 million and $1.4 million in revenue under the Grifols agreement for regulatory submission services related to the filing of the NDA, and regulatory approval services related to the NDA, respectively. No revenue was recognized for these contract components in the comparable period.

Total operating expenses for the third quarter of 2017 were $5.7 million, compared with total operating expenses of $7.3 million for the third quarter of 2016. The decrease in research and development expenses of $2.3 million was due to lower contract manufacturing and clinical trial costs because the Linhaliq Phase 3 clinical trials in non-cystic fibrosis bronchiectasis (NCFBE) are complete, offset by higher employee-related expenses due to the higher number of employees and higher consulting expenses in support of the Linhaliq regulatory process towards U.S. and European Union approvals for market authorization. The increase in general and administrative expenses of $0.7 million was primarily related to higher performance bonus expense, higher legal expenses, higher non-cash stock compensation expense and higher consulting expenses.

Net loss for the third quarter of 2017 was $3.9 million or $0.26 per share, compared with a net loss of $8.2 million or $0.55 per share in the third quarter of 2016. For the quarter ended September 30, 2017, the decrease in net loss resulted primarily from an increase in revenue of $2.7 million and a decrease in operating expenses of $1.6 million.

As of September 30, 2017, the Company reported cash and cash equivalents of $12.6 million, which includes the receipt of the $5 million milestone payment received from Grifols S.A. in September 2017 for the achievement of the Linhaliq NDA filing.

“Patients with non-cystic fibrosis bronchiectasis, and especially those with chronic lung infections with Pseudomonas aeruginosa, are at risk of experiencing pulmonary exacerbations that often require interventions with antibiotics and hospitalization. Linhaliq has been developed to reduce the number of these burdensome events. Our team is working closely with the U.S. Food and Drug Administration to support them in their ongoing review of the Linhaliq NDA in order to achieve the PDUFA (Prescription Drug User Fee Act) goal date of January 26, 2018,” said Igor Gonda, President and Chief Executive Officer, Aradigm Corporation.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the U.S. and over 200,000 people in Europe. NCFBE patients who have chronic infections with Pseudomonas aeruginosa have a 6.5-fold increase in hospitalization, three times higher mortality, and a worse quality of life compared with those without P. aeruginosa infections. There is currently no drug approved for the treatment of this condition.