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Akebia Therapeutics Announces Third Quarter 2017 Financial Results

On November 8, 2017 Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported financial results for the third quarter ended September 30, 2017 (Press release, Akebia, NOV 8, 2017, View Source [SID1234521785]).

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"Akebia continues to execute on our global Phase 3 program for vadadustat in collaboration with our partners," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "In the third quarter, we announced positive Phase 2 top-line results from our vadadustat study in Japanese patients with non-dialysis-dependent chronic kidney disease, and findings from the Phase 2 study in dialysis-dependent patients are expected by year end. In addition, our partner, Mitsubishi Tanabe Pharma Corporation, announced the initiation of Phase 3 clinical studies of vadadustat in Japan. Enrollment continues in the global clinical program with the potential launch of vadadustat in the United States, Europe and Japan anticipated in 2020. In addition, we look forward to initiating our TRILO2GY study later this year or early 2018."

Third Quarter 2017 and Recent Corporate Highlights

Announced positive top-line results from a Phase 2 study of vadadustat in Japanese patients with non-dialysis-dependent chronic kidney disease, which confirmed findings from previous studies of vadadustat;
After a positive consultation with the PMDA, partner Mitsubishi Tanabe Pharma Corporation (MTPC) announced the initiation of a Phase 3 development program of vadadustat in non-dialysis patients and patients receiving peritoneal dialysis in Japan;
Provided MTPC with an option to access data from Akebia’s global Phase 3 vadadustat program for payments to Akebia of up to $25 million; and
The Independent Data Monitoring Committee for Akebia’s global Phase 3 PRO2TECT and INNO2VATE programs held another meeting and recommended continuing the studies without modification.
Financial Results

Akebia reported a net loss of ($23.1) million, or ($0.49) per share, for the third quarter of 2017 as compared to a net loss for the third quarter of 2016 of ($36.3) million or ($0.96) per share.

Collaboration revenue was $41.3 million for the third quarter of 2017, which related to the Company’s agreements with Otsuka. Collaboration revenue in connection with Akebia’s agreement with MTPC is expected to commence in the fourth quarter of 2017.

Research and development expenses were $58.7 million for the third quarter of 2017 compared to $31.2 million for the third quarter of 2016. The increase is primarily attributable to external costs related to the global PRO2TECT and INNO2VATE Phase 3 programs, the Phase 2 studies in Japan, and activities related to the FO2RWARD and TRILO2GY programs. Research and development expenses were further increased by headcount and compensation-related costs.

General and administrative expenses were $6.7 million for the third quarter of 2017 compared to $4.9 million for the third quarter of 2016. The increase is primarily attributable to an increase in costs to support the Company’s research and development programs, including headcount and compensation-related costs and associated facility and patent-related costs.

Akebia ended the third quarter of 2017 with cash, cash equivalents and marketable securities of $329.7 million. The Company’s collaborators have committed up to $373.0 million or more in license and cost-share funding, which Akebia continues to receive on a quarterly prepaid basis. Akebia expects existing cash resources to fund the Company’s current operating plan into the second quarter of 2019. Thereafter, committed research and development funding will continue to be received from Otsuka on a prepaid, quarterly basis.

AmpliPhi Biosciences to Hold 2017 Third Quarter and Business Update Conference Call on November 14

On November 8, 2017 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of therapies for antibiotic-resistant infections using bacteriophage technology, reported that management will hold a business update conference call on Tuesday, November 14, 2017 beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) (Press release, AmpliPhi Biosciences, NOV 8, 2017, View Source [SID1234521787]).

Live Call: U.S. 866-652-5200
International 412-317-6060
Passcode 10114360

Live Webcast:
AmpliPhi IR Website
The webcast replay will be available approximately 2 hours after completion of the call and will be archived for 30 days.

Replay: U.S. 877-344-7529
International 412-317-0088
Passcode 10114360
The replay will be available for 48 hours starting approximately 2 hours after completion of the call.

Athersys Reports Third Quarter 2017 Results

On November 8, 2017 Athersys, Inc. (Nasdaq:ATHX) reported its financial results for the three months ended September 30, 2017 (Press release, Athersys, NOV 8, 2017, View Source [SID1234521789]).

Highlights of the third quarter of 2017 and recent events include:

Our partner in Japan, HEALIOS K.K. (Healios), resumed enrollment in the TREASURE stroke clinical trial, following a temporary suspension related to placebo product;
Entered into agreement with Nikon CeLL innovation Co., Ltd. (Nikon) to prepare for manufacturing of MultiStem cell therapy for future commercialization in Japan by Healios;
Awarded Regenerative Medicine Advanced Therapy designation (RMAT) from U.S. Food and Drug Administration (FDA) for MultiStem ischemic stroke program under the landmark 21st Century Cures Legislation, which is intended to expedite the development and regulatory review process and lead to accelerated U.S. approval;
Received Final Scientific Advice positive opinion for stroke program from European Medicines Device Agency (EMA), establishing alignment between European and U.S. regulators about potential for product approval following a successful MASTERS-2 study;
Progressed discussions with multiple parties regarding collaboration and business opportunities associated with stroke program;
Included in Deloitte’s Technology Fast 500, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences and energy tech companies in North America;
Recognized revenues of $0.4 million for quarter ended September 30, 2017 and net loss of $7.2 million, or $0.06 net loss per share; and
Maintained a stable balance sheet with cash and cash equivalents of $28.2 million at the end of the third quarter.
"Over the past year, we have submitted extensive data and information to the FDA, EMA and other regulators who have conducted a rigorous review of the results from the MASTERS-1 trial and the other information we have provided for their consideration," commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. "In response, we have received multiple important regulatory designations, including the Fast Track designation from the FDA earlier this year and, more recently, the RMAT designation, as well as the positive opinion from EMA. These actions provide tangible evidence of the support we have received from regulators following their careful review of the clinical data and information, and the potential this program has for redefining clinical care for patients that have suffered a debilitating ischemic stroke.

"We are pleased that Healios’ stroke study has resumed, following the resupply of placebo. In addition to our support for the ongoing TREASURE study and continued preparations for the MASTERS-2 study, we are laying the groundwork for commercialization in anticipation of clinical success. An important recent step was the establishment of a collaboration with Nikon to prepare for commercial manufacturing to support initial commercialization of MultiStem therapy for stroke in Japan. We are also engaged in related activities to support manufacturing scale-up and commercial supply."

Dr. Van Bokkelen continued, "We have also advanced our discussions with potential business partners to support development and commercialization activities, particularly related to our lead stroke program, and we are currently engaged in active negotiations, discussions and other activities regarding specific proposals with certain companies. As we have conveyed previously, we are intent on establishing one or more partnerships that balance our partner’s contribution of capabilities and resources, commitment to the program, and appropriate recognition of the value of the commercial opportunity. Though we are currently focused on several possible options, we cannot provide guidance about the precise nature, scope and size of any potential partnership while this process is ongoing. Needless to say, this remains an important priority and objective for the company and our shareholders."

Third Quarter Results

Revenues increased to $0.4 million for the three months ended September 30, 2017, compared to $0.3 million for the three months ended September 30, 2016, due to an increase of $0.1 million in grant revenues. Our grant revenues fluctuate from period to period based on the timing of grant-related activities and the award and expiration of new grants. Research and development expenses increased to $5.4 million for the three months ended September 30, 2017 from $5.3 million in the comparable period in 2016. The $0.1 million increase is primarily comprised of an increase in preclinical and clinical development costs of $0.8 million partially offset by decreases in internal research supplies of $0.4 million, sponsored research costs of $0.2 million and travel costs of $0.1 million.

General and administrative expenses increased to $2.1 million for the three months ended September 30, 2017 from $1.8 million in the comparable period in 2016. The $0.3 million increase was due primarily to increases in personnel costs of $0.1 million, stock-based compensation of $0.1 million and other administrative costs of $0.1 million.

Net loss was $7.2 million in the 2017 third quarter, compared to net loss of $6.0 million in the comparable period in 2016. The difference of $1.2 million reflects the above variances, as well as a non-recurring $0.2 million gain on the fair value of warrant liabilities and a non-recurring $0.7 million net gain from insurance proceeds related to flood damage, both of which were recognized in the third quarter of 2016.

Cash used in operating activities was $6.8 million during the 2017 third quarter, compared to cash used of $5.5 million in the 2016 third quarter. As of September 30, 2017, we had $28.2 million in cash and cash equivalents, compared to $14.8 million at December 31, 2016, which includes, among other things, the impact of the common stock offering in February 2017, the exercise of warrants to purchase common stock and proceeds from the issuance of common stock under our equity purchase facility.

Conference Call

Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (BJ) Lehmann, President and Chief Operating Officer, will host a conference call today to review the results as follows:

Date Wednesday, November 8, 2017
Time 4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada 800-273-1254
Telephone access: International 973-638-3440
Access code 96178367
Live webcast www.athersys.com, under the Investors section
A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on November 22, 2017 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 96178367.

Cascadian Therapeutics Reports Third Quarter 2017 Financial Results

On November 8, 2017 Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported financial results for the third quarter ended September 30, 2017, and provided an update on tucatinib, an investigational oral, small molecule kinase inhibitor that is highly selective for HER2 and the Company’s lead product in development for the treatment of HER2 overexpressing cancers (Press release, Cascadian Therapeutics, NOV 8, 2017, View Source [SID1234521791]).

Scott Myers, President and CEO of Cascadian Therapeutics, stated, "We had a productive third quarter. Tucatinib was granted orphan drug designation for a second indication, HER2+ colorectal cancer and enrollment began for an investigator-sponsored study of tucatinib in combination with trastuzumab in HER2 amplified metastatic colorectal cancer. Results from a pooled analysis of tucatinib combination studies were presented at ESMO (Free ESMO Whitepaper) that provide further support for the development of tucatinib in HER2+ metastatic breast cancer with brain metastases. Finally, enrollment of the HER2CLIMB pivotal trial continues to be robust, and we expect to end the year within our cash guidance."

Mr. Myers added, "We look forward to sharing new follow up data from our tucatinib Phase 1b studies at the San Antonio Breast Cancer Symposium in early December."

Third Quarter and Recent Highlights

● Tucatinib was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of HER2+ colorectal cancer. This is the second orphan designation for tucatinib, which also has orphan designation in breast cancer with brain metastases.

● Began enrollment in an investigator-initiated Phase 2 study of tucatinib in combination with trastuzumab for patients with HER2 amplified metastatic colorectal cancer. The study, known as MOUNTAINEER, is described on www.clinicaltrials.gov (NCT03043313).

● Presented at the European Society for Medical Oncology 2017 Congress in September results from a pooled analysis of Phase 1b combination studies supporting the potential utility of tucatinib for patients with HER2+ metastatic breast cancer with brain metastases, including untreated or progressive brain metastases after radiation therapy. Additional analyses of long-term patients in tucatinib studies will be presented at the 40th San Antonio Breast Cancer Symposium 2017 in early December. In addition, results of non-clinical studies were presented that support the MOUNTAINEER study, demonstrating tucatinib is active as a single agent in models of HER2+ colorectal cancer, as well as in other gastrointestinal cancers.

● Continued enrollment of HER2CLIMB pivotal trial, which is on track and enrolling in North America, Western Europe and Australia.

● Received positive regulatory feedback from the European Medicines Agency’s (EMA) Scientific Advice Working Group and Health Canada, validating the potential for the ongoing HER2CLIMB pivotal clinical trial and nonclinical programs to be sufficient for tucatinib registration, if data are supportive.

● Management is pursuing partnering opportunities for CASC-578, a Chk1 kinase inhibitor, and CASC-674, a TIGIT antibody program, and is closing internal laboratory operations to focus resources on tucatinib registration-enabling critical path activities.

Third Quarter Financial Results

● Cash, cash equivalents and investments totaled $113.0 million as of September 30, 2017, compared to $62.8 million at December 31, 2016. The increase was primarily due to net proceeds of $88.0 million from the Company’s January 2017 financing, less cash used in operations of $37.2 million.

● Net loss attributable to common stockholders for the three months ended September 30, 2017 was $14.1 million, or $0.28 per share, compared with a net loss attributable to common stockholders of $11.8 million, or $0.52 per share, for the comparable period in 2016. The $2.3 million increase in net loss attributable to common stockholders for the quarter was primarily due to an increase in research and development expenses of $3.6 million primarily due to greater activity related to the development of the Company’s product candidates, offset by a non-cash deemed dividend of $1.0 million related to the beneficial conversion feature on convertible preferred stock for the three months ended September 30, 2016.

● Net loss attributable to common stockholders for the nine months ended September 30, 2017 was $41.2 million, or $0.87 per share, compared to a net loss attributable to common stockholders of $49.8 million, or $2.74 per share, for the same period in 2016. The $8.6 million decrease in net loss attributable to common stockholders for the nine months ended September 30, 2017 was primarily due to the non-cash intangible asset impairment charge of $19.7 million offset by a $6.9 million tax benefit related to the reversal of the deferred tax liability, each of which was recorded in connection with the termination of the STC.UNM license agreement in 2016. In addition, the decrease was due to lower general and administrative expenses of $4.6 million primarily due to compensation-related expenses in connection with management changes in the first quarter of 2016 and lower non-cash expenses of $1.6 million from the deemed dividend related to the beneficial conversion feature on convertible preferred stock. The decrease in net loss attributable to common stockholders were partially offset by increases in research and development expenses of $11.0 million due to greater activity related to the development of the Company’s product candidates.

2017 Financial Outlook

Cascadian Therapeutics expects operating expenses in 2017 to be slightly higher than in 2016, primarily due to an increase in activities related to the ongoing worldwide HER2CLIMB pivotal trial. Cash used in operations for 2017 is expected to be approximately $50.0 million to $54.0 million.

Cascadian Therapeutics believes the above financial guidance to be correct as of the date hereof and is providing the guidance as a convenience to investors and assumes no obligation to update it.

Conference Call Information

Cascadian Therapeutics management will host a conference call and live audio webcast to review its third quarter financial results and provide an update on business activities today at 4:30 p.m. ET / 1:30 p.m. PT. Participants can access the call at +1 (877) 280-7291 (domestic) or +1 (707) 287-9361 (international). To access the live audio webcast or the subsequent archived recording, visit the Events & Presentations page of the News & Events section of the Cascadian Therapeutics’ website at www.cascadianrx.com.

FibroGen Reports Third Quarter 2017 Financial Results

On November 8, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, today reported financial results for the third quarter of 2017 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315520 [SID1234521792]).

"We have achieved significant clinical and regulatory progress in FibroGen’s product development programs. With the reporting of positive data from our placebo-controlled Phase 2 study of pamrevlumab for the treatment of moderate-to-severe idiopathic pulmonary fibrosis, we are very excited about the potential for pamrevlumab to help IPF patients who currently have few options. These results position us well on the path towards Phase 3 clinical development in IPF, as we continue to advance pamrevlumab in additional indications, where there is critical need for new therapies," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "With respect to roxadustat, the filing of our new drug application with the China Food and Drug Administration for the treatment of anemia associated with chronic kidney disease marks several important firsts for FibroGen, the HIF-PHI class of drugs, and towards the registration of a new chemical entity in China."

Recent Developments and Highlights
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Announced positive results from a randomized, placebo-controlled, double-blind Phase 2 study of pamrevlumab, a first-in-class fully human antibody targeting connective tissue growth factor (CTGF)
Presented Phase 2 findings in an oral presentation at the European Respiratory Society (ERS) International Congress in September 2017
Results also presented at the ERS meeting from a preclinical mouse radiation-induced lung fibrosis model showed that pamrevlumab monotherapy reduced fibrosis to a greater extent than either pirfenidone or nintedanib monotherapy, and that the results of combination therapy with either standard-of-care were not statistically significantly better than those for pamrevlumab alone
Clinical and preclinical data has been accepted for presentation in November 2017 at Pulmonary Fibrosis Foundation (PFF) Summit 2017 in Nashville, TN
Pamrevlumab for Pancreatic Cancer

We expect to define a registrational strategy in the first half of 2018
Roxadustat for Anemia in Chronic Kidney Disease (CKD)

New drug application (NDA) filing with the U.S. Food and Drug Administration targeted for 2018
Positive topline results reported from the first completed Japan roxadustat Phase 3 CKD trial, for the treatment of anemia in peritoneal dialysis patients in October 2017
In November 2017, the independent data safety monitoring board, which reviews the U.S. and European Phase 3 programs quarterly, recommended that all trials continue without modification to current protocols
Roxadustat for Anemia in Myelodysplastic Syndromes (MDS)

Phase 3 U.S. clinical trial anticipated to start in the fourth quarter of 2017
Roxadustat for Anemia in CKD in China

NDA accepted for review by the China Food and Drug Administration (CFDA) for anemia associated with CKD in dialysis-dependent and non-dialysis-dependent patients in October 2017
Twenty-six week data from the two Phase 3 trials showed correction of anemia and maintenance of hemoglobin levels, and comparable results with or without inflammation
Data from the fifty-two week safety extension study showed durability of effect
No safety signals were identified
Roxadustat for Anemia in MDS in China

Initiation of Phase 2/3 clinical study is planned for the fourth quarter of 2017/first quarter of 2018
Corporate and Financial Highlights

Appointed Gerald Lema to the company’s Board of Directors, adding extensive experience to FibroGen’s leadership in commercialization, finance, and strategy in the Asia Pacific region, as well as in Europe/Middle East and Africa, U.S., and Latin America
Earned $15.0 million milestone from partner AstraZeneca for the submission of the NDA for roxadustat in CKD to the CFDA in October 2017, which will be received and recognized as license and milestone revenue in the fourth quarter of 2017
Closed an equity financing in August 2017 that generated $356.2 million in net proceeds
Net loss per basic and diluted share for the quarter ended September 30, 2017 was $0.50, as compared to a net loss per based and diluted share of $0.38 a year ago
At September 30, 2017, FibroGen had $762.7 million of cash, restricted time deposits, cash equivalents, investments, and receivables
Conference Call Details
FibroGen will host a conference call and webcast today, November 8, 2017, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen Third Quarter 2017 conference call, and use the confirmation number 45903141. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use the passcode 45903141#.