On November 7, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the company will be participating in the following upcoming investor conferences (Press release, Loxo Oncology, NOV 7, 2017, View Source [SID1234521631]):

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Stifel 2017 Healthcare Conference on November 14, 2017, in New York City. At 2:45 p.m. ET Joshua H. Bilenker, M.D., chief executive officer, will present a corporate overview.
Evercore ISI Biopharma Catalyst/Deep Dive Conference on November 30, 2017, in Boston. At 4:35 p.m. ET Joshua H. Bilenker, M.D., chief executive officer, and Jacob S. Van Naarden, chief business officer, will be participating in a fireside chat.
Live webcasts of the presentation and fireside chat will be available at View Source A replay of each webcast will be available on the company’s website for 30 days.

On November 7, 2017 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended September 30, 2017, and provided an update on recent operational and clinical developments (Press release, Scynexis, NOV 7, 2017, View Source [SID1234521717]).

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"During the quarter, we continued to advance the clinical development of the SCY-078 platform in multiple indications and expanded the body of evidence supporting the versatility of SCY-078 and its activity against a wide variety of fungal diseases," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We’ve made significant progress in our lead studies, the DOVE study and the FURI study, and we look forward to continuing this momentum with the initiation of a new clinical study (the CARES study) in the fourth quarter to evaluate oral SCY-078 as a treatment for Candida auris infections, an increasingly urgent global health threat. We remain committed to advancing our vision of providing a novel treatment option to patients suffering from difficult-to-treat and often life-threatening infections."

SCY-078 Clinical and Regulatory Advancement

Dosing in Two Ongoing Clinical Studies Evaluating Oral SCY-078 Continues as Planned
Phase 2 dose-finding study (DOVE study) for the treatment of Vulvovaginal Candidiasis (VVC). Patient enrollment in this U.S.-based study is proceeding as planned with top-line results expected in mid-2018. This randomized, multicenter, double-blind, active-controlled, dose-finding Phase 2 study is designed to evaluate the safety and efficacy of five dosing regimens of oral SCY-078 compared to oral fluconazole, the standard of care.
Global, open-label study for the treatment of patients with invasive fungal infections that are refractory to or intolerant of standard antifungal agents (FURI study). Patient enrollment has started in this global study. It provides access to oral SCY-078 for patients battling invasive fungal infections, including multi-drug resistant, azole-resistant- or echinocandin-resistant Candida infections, who have failed other therapies and for whom treatment options are limited.
Global, Open-Label Candida auris Study (CARES Study) Opening for Patient Enrollment in the Fourth Quarter. Candida auris is a pathogen that is often multidrug-resistant, and systemic infections caused by Candida auris are associated with high mortality. The CARES study is designed to provide rapid access to oral SCY-078 for patients suffering from this life-threatening infection.
Clinical Development Status of Intravenous (IV) Formulation of SCY-078. Based on previous discussions with the U.S. Food and Drug Administration (FDA), SCYNEXIS is in the process of gathering the required data that will enable the submission of a complete response supporting the Company’s request to lift the clinical hold on the IV formulation of SCY-078. Upon lifting of the clinical hold, SCYNEXIS plans to test the intended IV dose regimen first in healthy volunteers before initiating a Phase 2 study for treatment of patients with invasive Candida infections. Commencement of this Phase 2 study is expected to occur in 2018.
Preclinical Data Support Clinical Activity of SCY-078

All recent scientific publications can be found at: View Source Based on promising in vitro and in vivo data of SCY-078 against Aspergillus infections, both as a single agent and in combination with standard of care, described in the first two data reports below, SCYNEXIS is evaluating potential clinical development steps for this indication.

Reported Data Further Showing SCY-078’s Activity in Numerous Potential Indications
IDWeek 2017 – SCY-078 as a potential treatment for Aspergillus and Candida infections. In October 2017, SCYNEXIS presented results from three studies supporting the potent and broad antifungal activity of SCY-078 against Candida and Aspergillus species. These results showed SCY-078’s potent activity against wild-type (WT) and azole-resistant strains of A. fumigatus, as well as against WT, azole-resistant and echinocandin-resistant strains of C. parapsilosis. In addition, SCY-078 showed significant and clinically-meaningful penetration into tissues relevant for the targeted indications, including lung, vaginal mucosa and kidney, following oral and IV administration in rats and mice.
TIMM 2017 – SCY-078 as a potential agent for combination therapy against Aspergillus spp. In October 2017, SCYNEXIS presented preliminary in vivo results of a study conducted by Thomas J. Walsh, M.D., Professor of Medicine in Microbiology and Immunology at Weill Cornell Medical College, and his team. SCY-078 was evaluated alone and in combination with isavuconazole in a neutropenic rabbit model of pulmonary aspergillosis. Preliminary results showed that SCY-078, when administered with isavuconazole, led to better outcomes than single agents.
IDSOG Annual Meeting – SCY-078 as a potential treatment of VVC. In August 2017, SCYNEXIS presented results highlighting SCY-078’s high penetration into vaginal tissue after oral administration and its potent anti-Candida activity in acidic pH conditions, characteristic of the vaginal setting, supporting the use of SCY-078 as a novel treatment of VVC.
Third Quarter 2017 Financial Results
Cash, cash equivalents and short-term investments totaled $47.7 million as of September 30, 2017, with net working capital of $42.0 million. We believe that our existing cash and cash equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2019.

Research and development, net expenses, decreased to $4.5 million in the third quarter of 2017, compared with $4.9 million in the third quarter of 2016. The decrease of $0.4 million, or 8.8%, for the three months ended September 30, 2017, was primarily driven by a decrease of $0.3 million in both clinical and preclinical development and a net increase of $0.2 million in other research and development expenses.

Selling, general and administrative expenses increased to $2.0 million in the third quarter of 2017, compared with $1.9 million in the third quarter of 2016. The increase of $0.1 million, or 6.6%, was primarily driven by an increase of $0.1 million in stock-based compensation, a $0.1 million decrease in professional services and a $0.1 million net increase in other selling, general and administrative expenses.

Total other expense decreased to $2.0 million in the third quarter of 2017, compared with $4.5 million in the third quarter of 2016. The decrease of $2.5 million, or 55.7%, was primarily driven by a decrease of $2.9 million in the non-cash loss recorded on the adjustment in the fair value of the warrant liability, offset in part by a $0.4 million increase in interest expense.

Net loss for the third quarter of 2017 was $8.4 million, or $0.31 per share. This compares with a net loss for the third quarter of 2016 of $11.2 million, or $0.48 per share.

About SCY-078
SCY-078 is an antifungal agent in clinical and preclinical development for the treatment of fungal infections caused by Candida and Aspergillus species. SCY-078, a semi-synthetic derivative of the natural product enfumafungin, is the first representative of a family of triterpenoids—a structurally distinct and novel class of glucan synthase inhibitors. SCY-078 combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having IV and oral formulations. By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The FDA granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis.On

On November 7, 2017 MannKind Corporation (NASDAQ:MNKD) reported financial results for the third quarter and the nine months ended September 30, 2017. Third quarter highlights include (Press release, Mannkind, NOV 7, 2017, View Source [SID1234521715]):

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Afrezza net revenue grew 28% and 246% vs. 2Q 2017 and 3Q 2016, respectively
Cash burn of $23.3 million in 3Q 2017
Exchanged all outstanding Series A and B Common Stock Warrants for an aggregate of 1.3 million shares of the Company’s common stock
FDA approved label changes for Afrezza
Other recent highlights include:

Issued 10.2 million shares of the Company’s common stock in a registered direct offering resulting in receipt of net proceeds of $57.7 million
Exchanged senior convertible notes of $27.7 million due August 2018 for senior convertible notes of $23.7 million due October 2021 and 973,236 shares of the Company’s common stock
Extended the maturity of $10 million of the Deerfield obligation from October 31, 2017 to January 15, 2018
Allowed for certain outstanding principal under the Deerfield obligation to be converted into shares of the Company’s common stock (including the $10 million due January 2018). 4 million shares have been reserved for conversion.
Third Quarter Results

For the third quarter of 2017, Afrezza net revenue of $2.0 million grew 28% vs. the second quarter of 2017 and 246% vs. the third quarter of 2016 (the first quarter for MannKind sales and commercial support of Afrezza after the termination of the Sanofi agreement). As of September 30, 2017, the amount of Afrezza shipped to the wholesale and retail channels, but not yet recognized as revenue, was $3.0 million, an increase of $0.4 million from June 30, 2017. A reconciliation of gross to net revenues can be found in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of the Form 10-Q for the quarter ended September 30, 2017.

Cost of goods sold was $4.6 million in the third quarter of 2017 compared to (i) $5.1 million in the second quarter of 2017, a decrease of $0.5 million primarily related to a write-down of inventory in the second quarter, and (ii) $4.4 million in the third quarter of 2016, an increase of $0.2 million.

Research and development expenses were $4.4 million in the third quarter of 2017 compared to (i) $3.1 million in the second quarter of 2017, an increase of $1.3 million primarily related to starting the Time in Range ("STAT" study) and the pediatric study, and (ii) $4.0 million in the third quarter of 2016, an increase of $0.4 million, primarily due to increases in clinical trials partially offset by a decrease in compensation expense related to a reduction in workforce in the fourth quarter of 2016.

Selling, general and administrative expenses were $17.7 million for the third quarter of 2017 compared to (i) $18.6 million for the second quarter of 2017, a decrease of $1.1 million primarily from a reduction in commercial support expenses and (ii) $13.1 million in the third quarter of 2016, an increase of $4.6 million primarily due to scaling up the Afrezza commercial infrastructure during the first quarter of 2017.

The net loss for the third quarter of 2017 was $32.9 million, or a loss of $0.31 per share based on 104.7 million weighted average shares outstanding, compared to net income of $126.5 million, or $1.32 per share on 95.6 million weighted average shares outstanding in the third quarter of 2016. The net income in the third quarter of 2016 included net revenue – collaboration of $161.8 million related to the termination of the Sanofi agreement.

Nine Months Results

Due to the termination of the Sanofi agreement in early 2016 and MannKind’s commencement of commercial activities for Afrezza in the third quarter of 2016, a comparative analysis for sales and commercial support between the nine months ended September 30, 2017 and September 30, 2016 is not meaningful.

For the nine months ended September 30, 2017, total net revenue of $7.2 million was comprised of $4.7 million of Afrezza net sales, $1.7 million from the net sales of surplus bulk insulin to a third party, $0.6 million from the sale of certain oncology intellectual property, and $0.2 million from collaboration net revenue.

Cost of goods sold was $12.2 million for the nine months ended September 30, 2017 compared to $12.9 million for the same period in 2016, a decrease of $0.7 million.

Research and development expenses were $10.6 million for the nine months ended September 30, 2017 compared to $13.4 million for the same period in 2016, a decrease of $2.7 million or 21%, due primarily to a decrease in compensation expense of $5.1 million as a result of the reduction in workforce in the fourth quarter of 2016. This decrease was partially offset by a $2 million increase in clinical trial expense.

Selling, general and administrative expenses were $51.7 million for the nine months ended September 30, 2017 compared to $31.6 million for the same period in 2016, an increase of $20.1 million due to the change in the commercial support structure after termination of the Sanofi agreement in 2016.

The net loss for the nine months ended September 30, 2017 was $84.5 million, or a loss of $0.84 per share based on 100.1 million weighted average shares outstanding, compared to net income of $71.7 million, or $0.79 per share on 90.8 million weighted average shares outstanding at September 30, 2016.

Cash and Cash Equivalents

Cash and cash equivalents at September 30, 2017 decreased to $20.1 million from $43.4 million at June 30, 2017, primarily due to cash burn for the third quarter of 2017 of $23.3 million. The cash balance as of September 30, 2017 does not include $57.7 million of net proceeds received from the registered direct offering of the Company’s common stock completed in October 2017.

Afrezza Label Change

On September 29, 2017, the U.S. FDA approved an update to the Afrezza prescribing information for the inclusion of study data that describes the time action profile by dosage strength; clarity on "Starting" and "Adjusting" mealtime doses; and updated pregnancy and lactation guidance.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. To view and listen to the earnings call webcast, visit MannKind’s website at View Source and click on the "Q3 2017 MannKind Earnings Conference Call" link in the Webcast section of News & Events. To participate in the live call by telephone, please dial (888) 771-4371 or (847) 585-4405 and use the participant passcode: 44096374.

A telephone replay will be accessible for approximately 14 days following completion of the call by dialing (888) 843-7419 or (630) 652-3042 and use the participant passcode: 4409 6374#. A replay will also be available on MannKind’s website for 14 days.

On November 7, 2017 Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, reported financial results for the third quarter ended September 30, 2017, and provided a corporate update (Press release, Alder Biopharmaceuticals, NOV 7, 2017, View Source [SID1234521711]).

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"In the third quarter, we continued to showcase the positive results of eptinezumab, our lead pivotal-stage product candidate for the prevention of migraine, and recently had seven presentations at the 18th Congress of the International Headache Society," said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder. "We are encouraged by the migraine community’s excitement regarding eptinezumab’s unique clinical profile, including migraine prevention as early as Day 1 and >75% responder rates achieved by month one and sustained for three months from one administration. As the first-to-market anti-CGRP infusion therapy, we are confident that eptinezumab can address a distinct market segment of five million of the most severe episodic and chronic patients who are heavily impacted by migraine. Importantly, we remain on track to announce top-line data our PROMISE 2 Phase 3 pivotal trial in the first half of 2018 and complete our planned BLA submission in the second half of 2018. We look forward to delivering on our mission to transform the treatment of migraine and creating long-term value for our shareholders."

Recent Corporate Highlights

•
Completed patient enrollment in PROMISE 2 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 2), the Company’s ongoing Phase 3 pivotal trial evaluating the safety and efficacy of eptinezumab administered via infusion once every three months in approximately 1,050 patients with chronic migraine.

•
Delivered seven presentations at the 18th Congress of the International Headache Society (IHC) in Vancouver, Canada in September 2017 providing clinical data and analyses for eptinezumab, including additional Phase 3 data from the PROMISE 1 Phase 3 pivotal trial and analyses of Alder’s Phase 2b clinical trial. The data presented further supported eptinezumab’s clinical profile as a potential first-of-its-kind, highly differentiated infusion therapy to prevent migraine.

Upcoming Milestones

•
Report top-line data from the PROMISE 2 pivotal trial in the first half of 2018.

•
Submit the BLA for eptinezumab with the U.S. Food and Drug Administration (FDA) in the second half of 2018.

Third Quarter 2017 Financial Results

Research and development expenses for the quarter ended September 30, 2017 totaled $52.2 million, compared to $29.5 million for the same period in 2016. This increase over the same period last year reflects the company’s commitment to advancing the pivotal-stage eptinezumab program and commercialization preparations.

General and administrative expenses for the quarter ended September 30, 2017 totaled $8.2 million, compared to $6.2 million for the same period in 2016. The increases in spending were primarily due to an increase in stock-based compensation expense and salaries due to headcount growth, and an increase in professional fees and other administrative costs primarily to support commercial readiness activities.

Net loss for the quarter ended September 30, 2017 totaled $59.6 million, or $0.92 per share, compared to net loss of $35.1, or $0.70 per share, on a fully-diluted basis, for the same period in 2016.

Cash, cash equivalents, short-term investments and restricted cash totaled $340.9 million as of September 30, 2017, compared to $224.5 million as of June 30, 2017.

Financial Outlook

Alder estimates its available cash and cash equivalents and short-term investments, will be sufficient to meet the company’s projected operating requirements through late 2018/early 2019 and enable the Company to achieve the planned BLA submission for eptinezumab and other key eptinezumab activities.

Conference Call and Webcast

Alder will host a conference call today at 5:00 p.m. ET to discuss these financial results and recent corporate highlights. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers, and providing conference ID number 4399736. The webcast will be broadcast live and can be accessed from the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The webcast will be available for replay following the call for 30 days.

On November 7, 2017 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that it will host a conference call and live audio webcast on Wednesday, November 8, 2017, at 8:00 a.m. (ET) to review data from the Phase 1a/1b clinical trial evaluating the immunotherapy combination of its CSF-1R antibody, cabiralizumab (FPA008), with Opdivo (nivolumab), Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor. An abstract of the data has been selected for a late-breaking oral presentation on Saturday, November 11, 2017, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting in National Harbor, Maryland. The late-breaking abstracts were published today by SITC (Free SITC Whitepaper) (Press release, Five Prime Therapeutics, NOV 7, 2017, View Source [SID1234521676]).

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Five Prime originally intended to host the call and webcast on November 7, 2017, but an extended GlobeNewswire outage prevented a press release from being issued. In advance of the event tomorrow, Five Prime will file a Current Report on Form 8-K with the Securities and Exchange Commission that will include the slides to accompany the conference call presentation and discussion. Five Prime’s management will provide important additional details during the call.

The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company’s website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 8687899.

The archived conference call will be available on Five Prime’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.