On November 7, 2017 Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, reported a corporate update and financial results for the third quarter ended September 30, 2017 (Press release, Acceleron Pharma, NOV 7, 2017, View Source [SID1234521623]).

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"As we think about and plan to execute on our long-term vision and strategy, there were several significant corporate events in the third quarter. At our September R&D day, we outlined our core research and development focus in three disease areas of high unmet medical need: hematology, neuromuscular, and pulmonary disease. We announced that we gained rights to sotatercept, an internally discovered Phase 2 asset, for the development in pulmonary arterial hypertension. We also completed a successful equity offering that will provide sufficient funding through key inflection points in each of our clinical programs," said Habib Dable, President and Chief Executive Officer of Acceleron. "We and our partner Celgene continue to invest heavily in our luspatercept development plan with seven clinical trials expected to be ongoing in 2018. In neuromuscular diseases, ACE-083 continues to advance in the Phase 2 trials in FSHD and CMT, and we remain on track to launch a Phase 2 trial with sotatercept in the first half of 2018 as we work to grow our pulmonary franchise, and ultimately deliver transformative treatment options to patients in need."

Development Program Highlights

Hematology

Luspatercept:

Myelodysplastic Syndromes (MDS), Beta-Thalassemia, and Myelofibrosis

Luspatercept is designed to treat chronic anemia and reduce red blood cell (RBC) transfusion burden in adults with rare blood disorders. Luspatercept is being developed as part of the global collaboration between Acceleron and Celgene.

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In addition to the ongoing MEDALIST and BELIEVE Phase 3 trials, Acceleron and Celgene continue to prepare for clinical trial expansion in new patient populations, including the COMMANDS Phase 3 trial in first-line, lower-risk MDS, regardless of ring sideroblast status, the BEYOND Phase 2 trial in non-transfusion-dependent beta-thalassemia, and the Phase 2 trial in myelofibrosis.

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Results from the Phase 2 trial of luspatercept for the treatment of anemia in patients with lower-risk MDS were recently published in The Lancet Oncology.

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Data from two clinical abstracts on luspatercept and sotatercept will be presented at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Atlanta, GA on December 9-12, 2017.

Neuromuscular Disease

ACE-083:

Facioscapulohumeral muscular dystrophy (FSHD) and Charcot-Marie-Tooth (CMT) disease

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ACE-083 is a locally-acting therapeutic designed to have a concentrated effect on muscle mass and strength in target muscles for diseases that cause debilitating focal muscle loss by utilizing the "Myostatin+" approach to inhibit multiple TGF-beta ligands.

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Enrollment and treatment are ongoing in Part 1 of the Phase 2 trial in patients with FSHD, one of the most prevalent forms of muscular dystrophy in adults.

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Enrollment and treatment are ongoing in Part 1 of the Phase 2 trial in patients with CMT disease, one of the most common inherited neurological diseases leading to focal muscle weakness.

ACE-2494:

ACE-2494 is a protein therapeutic designed to have a systemic effect on muscle mass and strength throughout the body by utilizing the "Myostatin+" approach to inhibit multiple TGF-beta ligands.

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The Company plans to initiate a Phase 1 healthy volunteer clinical trial this year and is actively evaluating a potential first indication.

Pulmonary Disease

Sotatercept:

Sotatercept is an activin receptor type IIA fusion protein that acts as a ligand trap for members in the TGF-beta protein superfamily involved in remodeling and regeneration of a variety of different tissues, including the vasculature and fibrotic tissue.

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Acceleron gained development and commercialization rights for pulmonary arterial hypertension (PAH).

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Preclinical results presented at R&D day show potential for sotatercept to be a first-in-class disease-modifying therapy that addresses fundamental molecular causes of disease in PAH.

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Preclinical results of sotatercept in PAH will be highlighted in an oral presentation at the American Heart Association Scientific Sessions 2017 in Anaheim, CA on November 14, 2017.

Key Corporate Priorities

Luspatercept
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Report top-line results from MEDALIST and BELIEVE Phase 3 trials in mid-2018
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Initiate the COMMANDS Phase 3 trial in first-line, lower-risk MDS in 1H 2018
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Enroll the first myelofibrosis patient in Phase 2 by YE 2017
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Initiate the BEYOND Phase 2 trial in non-transfusion-dependent beta-thalassemia by YE 2017

ACE-083
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Report FSHD Phase 2 results for cohort 1 in Part 1 in January 2018
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Report FSHD Phase 2 results for all dose-escalation cohorts in Part 1 in 2018
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Report CMT Phase 2 results from all dose-escalation cohorts in Part 1 by YE 2018

ACE-2494
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Initiate Phase 1 healthy volunteer trial in 2017

Sotatercept
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Initiate Phase 2 trial in PAH first half of 2018

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Financial Results
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Cash position – Cash, cash equivalents and investments as of September 30, 2017 were $366.6 million. As of December 31, 2016 the Company had cash, cash equivalents and investments of $234.4 million. Cash, cash equivalents and investments include $187.6 million of net proceeds from a follow-on public offering of common stock in September 2017. In October 2017, the underwriters exercised the over-allotment option in the offering which resulted in additional net proceeds of $28.2 million. We believe that existing cash, cash equivalents and investments, including the net proceeds from the offering and the exercise of the underwriters’ over-allotment option, will be sufficient to fund projected operating requirements into 2021.
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Revenue – Collaboration revenue for the third quarter was $3.0 million. The revenue is all from our Celgene partnership and is primarily due to cost sharing revenue of $2.9 million related to expenses incurred by the Company in support of our partnered programs.
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Costs and expenses – Total costs and expenses for the third quarter were $28.6 million. This includes R&D expenses of $21.1 million and G&A expenses of $7.5 million.
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Net loss – The Company’s net loss for the third quarter ended September 30, 2017 was $25.5 million.

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Conference Call and Webcast
The Company will host a webcast and conference call to discuss its third quarter 2017 financial results and provide an update on recent clinical development and corporate activities on November 7, 2017, at 8:00 a.m. EST.
The webcast will be accessible under "Events & Presentations" in the Investors/Media page of the Company’s website at www.acceleronpharma.com. Individuals can participate in the conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and refer to the "Acceleron Third Quarter Earnings Call".
The archived webcast will be available for replay on the Acceleron website approximately two hours after the event.

On November 7, 2017 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology, reported financial results for the third quarter of 2017 and provided an update on its clinical development programs (Press release, Aclaris Therapeutics, NOV 7, 2017, View Source [SID1234521624]).

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"The third quarter of 2017 has been a productive one for Aclaris. In August, we closed the acquisition of Confluence Life Sciences, Inc. ("Confluence"), and we continue to prepare for our December 24th PDUFA date for A-101 40% Topical Solution for the treatment of seborrheic keratosis," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

Clinical Pipeline Update
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A-101 40% Topical Solution
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In September, published results from a Phase 2 clinical trial evaluating two concentrations (40% and 32.5%) of its drug candidate A-101 for the treatment of facial seborrheic keratosis (SK) lesions in the journal Dermatologic Surgery. In the trial, A-101 achieved statistically significant improvement in clearing SK lesions on the face in a dose-related fashion. A-101 was well tolerated at both concentrations studied.
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The FDA’s Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) is December 24, 2017. If approved, A-101 40% Topical Solution would be the first FDA-approved medication for SK.

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A-101 45% Topical Solution
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In June, initiated two Phase 2 clinical trials of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts. The Phase 2 clinical trials are designed to evaluate the safety, tolerability and dose frequency of A-101 45% compared with placebo in adult and pediatric patients.

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Enrollment in both phase 2 trials has been completed and 316 patients have been enrolled in the two double-blinded trials which are being conducted at 34 investigational centers within the United States. Aclaris expects to report data from these two trials in the first half of 2018.

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JAK Inhibitors
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In October, initiated a Phase 2 clinical trial of ATI-50002, a topical Janus Kinase (JAK) 1/3 inhibitor (ATI-50002 Topical) for the treatment of alopecia areata (AA). This trial will evaluate the pharmacokinetics, pharmacodynamics and safety of ATI-50002 Topical compared with placebo in 12 patients with AA. This randomized, double-blind clinical trial is being conducted at two investigational centers within the United States, and data is expected to be available in the first half of 2018.
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In November, initiated a Phase 2 open-label clinical trial of ATI-50002 Topical for the treatment of AA. This trial will evaluate the effect of ATI-50002 Topical on the regrowth of eyebrows in up to 24 patients with AA. This trial is being conducted at two investigational centers in Sydney and Melbourne, Australia, and data is also expected to be available in the first half of 2018.
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Continue plans to initiate a Phase 2 dose ranging trial of ATI-50002 Topical for the treatment of AA next week. This study is a randomized, double-blinded, parallel-group, vehicle controlled trial and plan to enroll approximately 120 patients at 20 investigational centers within the United States. Data is expected to be available by year end 2018.
o
Continue plans to initiate a Phase 2 open-label clinical trial of ATI-50002 Topical for the treatment of vitiligo by the end of 2017.
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Now plan to initiate a Phase 2 dose ranging trial of ATI-50001, an oral JAK inhibitor, for the treatment of AA in the first half of 2018.
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Continue to develop another series of topical JAK inhibitors for the treatment of androgenetic alopecia (AGA).

Business Highlights and Recent Developments

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In August, completed the acquisition of Confluence, a privately held biotechnology company focused on the discovery and development of kinase inhibitors to treat inflammatory and immunological disorders and cancer.
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In August, raised net proceeds of $80.9 million from a follow-on offering of our common stock.
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In September, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 9,737,469 and U.S. Patent No. 9,730,877, and the Japan Patent Office issued Japanese Letters Patent No. 6212107. These patents are directed to methods related to the use and administration of certain JAK inhibitors for treating hair loss disorders. These newly issued patents are owned by The Trustees of Columbia University in the City of New York and exclusively licensed to Aclaris.
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U.S. Patent No. 9,730,877 covers the use of various JAK inhibitors, including tofacitinib, baricitinib, ruxolitinib and decernotinib, to treat AGA, also known as male/female pattern hair loss. The ‘877 Patent contains 22 claims and expires in November 2031.
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U.S. Patent No. 9,737,469 covers the use of baricitinib for inducing hair growth and for treating hair loss disorders such as AA and AGA. Additional issued claims pertain to methods of using baricitinib to treat particular phenotypes of AA, as well as to treat other hair loss disorders. The ‘469 Patent contains 10 claims and expires in November 2031.
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Japanese Letters Patent No. 6212107 covers the use of tofacitinib in a topical composition or as the sole active therapeutic agent in a pharmaceutical composition for inducing hair growth and for treating hair loss disorders, such as AA and AGA. The ‘107 patent issued with 25 claims and expires in March 2033.
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In October, Columbia University received a Notice of Allowance from the USPTO for a patent application covering methods of treating a hair-loss disorder, such as AA and AGA, or inducing hair growth, by administering tofacitinib topically or by administering tofacitinib as the sole active ingredient, and treating AGA or inducing hair growth in a subject having AGA by administering tofacitinib. The application was allowed with 66 claims.
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In October, hosted inaugural R&D and Investor Day event.

Financial Highlights

Liquidity and Capital Resources
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As of September 30, 2017, Aclaris had aggregate cash, cash equivalents and marketable securities of $227.8 million compared to $174.1 million as of December 31, 2016. The $53.7 million increase during the nine months ended September 30, 2017 included:

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Aggregate net proceeds of $100.2 million from the public offering of common stock in August 2017 and the sale of common stock under an at-the-market facility with Cowen in May 2017.

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$9.6 million of cash used to acquire Confluence, net of cash acquired.

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Net loss of $45.6 million and $1.2 million of net cash used in working capital, partially offset by $10.4 million of non-cash stock-based compensation expense, depreciation and amortization.

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Aclaris anticipates that its cash, cash equivalents and marketable securities as of September 30, 2017 will be sufficient to fund its operations into the second half of 2019, without giving effect to any potential new business development transactions or financing activities.

Third Quarter 2017 Financial Results
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Net loss was $18.2 million for the third quarter of 2017, compared to $10.7 million for the third quarter of 2016.
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Revenue of $0.7 million and cost of revenue of $0.5 million for the third quarter of 2017 related to Confluence’s contract research organization (CRO) business acquired in August 2017.
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Total operating expenses for the third quarter of 2017 were $19.0 million, compared to $10.8 million for the third quarter of 2016.
o
Research and development expenses were $10.9 million for the third quarter of 2017, compared to $7.2 million for the third quarter of 2016. The increase of $3.7 million was primarily attributable to a $1.2 million increase in expenses related to the Phase 2 clinical trials of A-101 45%, a $1.3 million increase in personnel-related expenses, including stock-based compensation, due to increased

headcount, a $0.9 million increase in preclinical and clinical trial development expenses related to the JAK inhibitor technology and a $0.9 million increase in medical affairs expenses and other costs, including early stage drug discovery, offset in part by a $1.2 million decrease in clinical costs for A-101 40% Topical Solution resulting from the completion of Phase 3 clinical trials in November 2016.

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General and administrative expenses were $8.1 million for the third quarter of 2017, compared to $3.7 million for the third quarter of 2016. The increase of $4.4 million was primarily attributable to $1.9 million in higher personnel-related expenses, including stock-based compensation, due to increased headcount, and $0.4 million in expenses related to the acquisition of Confluence. Additionally, Aclaris had a $1.6 million increase in market research and sales operations expenses related to pre-commercial activities for A-101 40% Topical Solution.

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As of September 30, 2017, Aclaris had approximately 30.8 million shares of common stock outstanding.

2017 Financial Outlook
Aclaris is updating its estimates for the following financial metrics for the full year 2017, which estimates now incorporate the acquisition of Confluence:

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Cash burn for 2017, excluding this year’s financing activities and cash paid in the Confluence acquisition, is now estimated to be in the range of $56 million to $59 million compared to previous guidance of $65 million to $70 million.

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Total operating expenses for 2017 are now estimated to be in the range of $72 million to $75 million, or $57 million to $60 million when excluding estimated stock-based compensation expense of $15 million. Prior guidance for operating expenses was $84 million to $92 million, or $70 million to $75 million when excluding stock-based compensation of $14 to $17 million.

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Research and development expenses for 2017 are now estimated to be in the range of $39 million to $42 million, or $33 million to $36 million when excluding estimated stock-based compensation expense of $6 million. Prior guidance for research and development expenses was $51 million to $58 million, or $46 million to $52 million when excluding stock-based compensation of $5 million to $6 million.

Company to Host Conference Call
Management will conduct a conference call at 8:00 AM ET today to discuss Aclaris’ financial results and provide a general business update. The conference will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.
To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 99295180 prior to the start of the call.

On November 7, 2017 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported financial results for the quarter ended September 30, 2017 (Press release, Affimed, NOV 7, 2017, View Source [SID1234521625]).

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"We continue to make great strides in validating our NK cell engager programs, in particular through encouraging data from studies of our lead candidate AFM13, which is progressing through clinical development as a mono- and combination therapy," said Dr. Adi Hoess, CEO of Affimed. "Leveraging our unique NK cell-based platform for high-affinity CD16A-targeting, we are advancing our tetravalent bispecific antibodies with the potential to tailor immune-engaging therapy to different indications and settings."

Third Quarter Updates

Corporate Update

· In September 2017, Dr. Wolfgang Fischer, former Global Head of Program and Project Management of Sandoz Biopharmaceuticals (Novartis Group) joined Affimed as Chief Operating Officer. Dr. Fischer has over 20 years of R&D experience with a focus on oncology, immunology and pharmacology. With his proven track record in drug development, he will support the Company in advancing its unique immune cell engagers to address the existing medical need in hematologic and solid tumor indications. In addition to his role as COO, Dr. Fischer will assume responsibility as interim CMO, working closely with the Company’s clinical team.

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NK cell engager programs

· In Affimed’s Phase 1b combination study of its lead product candidate, the CD30/CD16A-targeting NK cell engager AFM13, with Merck’s Keytruda (pembrolizumab) in Hodgkin lymphoma (HL), the dose expansion cohort is open and recruiting. Data analysis of three-month response rates is ongoing for the escalation phase of the trial with analysis of 9 out of 12 patients completed to date. Of the 3 patients enrolled into cohort 1, two experienced partial metabolic responses, while one patient progressed. Of the 3 patients enrolled into cohort 2, one patient experienced a complete metabolic response, one patient experienced a partial metabolic response and one patient progressed. Out of the six patients in dose cohort 3, three were analyzed to date, all of which experienced partial metabolic responses at the first tumor response assessment. The Company intends to present detailed dose escalation data including response data of the three remaining patients in cohort 3 at the upcoming ASH (Free ASH Whitepaper) 2017 Annual Meeting in December.

· Affimed is supporting a translational Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University. The study is designed to allow for serial biopsies, thereby enabling assessment of NK cell biology and tumor cell killing within the tumor microenvironment. The first cohort has been fully enrolled and recruitment into further cohorts is ongoing. The first patient, suffering from anaplastic large-cell lymphoma (ALCL) with cutaneous manifestation, experienced a complete response of cutaneous lesions after the first treatment cycle. Systemic evaluation is ongoing. This provides first evidence that NK cell engagers are able to induce tumor regression in this indication.

· The Company’s investigator-sponsored Phase 2a monotherapy study of AFM13 in HL led by the German Hodgkin Study Group (GHSG), is open to recruit under the new design, which includes patients pre-treated with both brentuximab vedotin (B.V.) and anti-PD1.

· In Affimed’s collaboration with The University of Texas MD Anderson Cancer Center (MDACC) evaluating the Company’s NK cell engager AFM13 in combination with MDACC’s NK cell product, preclinical research activities are progressing.

· The Company has developed multiple tetravalent, bispecific antibody formats in addition to its TandAbs. These molecules confer distinct biophysical properties aimed at tailoring PK profiles. Based on its platform, Affimed is advancing AFM24, an EGFR/CD16A-specific NK cell engager and AFM26, a BCMA/CD16A-specific NK cell engager, through IND-enabling studies. Final candidates have been selected for AFM24 and AFM26, respectively.

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· Candidates for AFM24, developed to treat solid tumors, are based on both TandAb format and on novel proprietary antibody formats. AFM24 molecules offer a differentiated mode of action as compared to cetuximab. Furthermore, binding to NK cells is largely unaffected by IgG competition, resulting in higher efficacy and elimination of cells with low target expression. Affimed is currently evaluating its novel format-based AFM24 molecules, which have significantly longer half-lives, in comparison to the Company’s TandAbs, which have already shown evidence of a beneficial safety profile.

· AFM26 is designed to eliminate malignant cells in multiple myeloma (MM) independent of BCMA expression levels. AFM26 offers a differentiated mode of action, targeting cells expressing very low levels of BCMA, conferring NK cell cytotoxicity and eliciting lower cytokine release compared to a BiTE molecule. Furthermore, binding to NK cells is largely unaffected by IgG competition. These unique features could position AFM26 in patients receiving autologous stem cell transplant (ASCT)-eligible at or shortly after transplant, a period in which no treatment is currently available.

T cell engager programs

· Affimed is conducting two clinical Phase 1 dose-escalation trials with AFM11, a CD3/CD19-targeting tetravalent bispecific T cell engager in patients with relapsed and refractory (r/r) acute lymphocytic leukemia (ALL) and with r/r non-Hodgkin lymphoma (NHL), respectively. Both studies are ongoing and recruiting.

· Recruitment is ongoing into a first-in-human Phase 1 dose escalation trial of AMV564 conducted by Amphivena Therapeutics, Inc. in patients with r/r acute myeloid leukemia (AML). AMV564 is a CD33/CD3-specific antibody based on Affimed’s technology platform. Affimed owns ~18.5% of Amphivena (fully diluted).

Financial Highlights
(Figures for the third quarter and first nine months of 2017 and 2016 represent unaudited figures)

Cash and cash equivalents and financial assets totaled €41.8 million as of September 30, 2017 compared to €44.9 million as of December 31, 2016. Affimed’s operational expenses for the nine months ended September 30, 2017 were primarily offset by net proceeds of €16.4 million from a public offering of common shares in the first quarter and of €2.5 million from the drawdown of the second tranche of the loan from Silicon Valley Bank.

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Net cash used in operating activities was €20.7 million for the nine months ended September 30, 2017 compared to €25.5 million for the nine months ended September 30, 2016. The decrease was primarily related to lower cash expenditure for research and development (R&D) in connection with Affimed’s development and collaboration programs and to the expiration of the Amphivena collaboration.

Revenue for the third quarter of 2017 was €0.5 million compared to €0.9 million for the third quarter of 2016. Revenue in the 2017 period was derived from AbCheck services while revenue in the 2016 period related predominantly to Affimed’s collaboration with Amphivena.

R&D expenses for the third quarter of 2017 were €6.0 million compared to €8.8 million for the third quarter of 2016. The decrease was primarily related to lower expenses for AFM13 and our discovery/early stage development activities.

G&A expenses for the third quarter of 2017 were €1.9 million compared to €2.2 million for the third quarter of 2016.

Net loss for the third quarter of 2017 was €8.1 million, or €0.18 per common share, compared to a net loss of €10.3 million, or €0.31 per common share, for the third quarter of 2016. The decrease of operating expenses was partially offset by lower revenue and higher finance costs.

Note on IFRS Reporting Standards
Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed’s management will host a conference call to discuss the company’s financial results and recent corporate developments today at 8:30 a.m. ET. A webcast of the conference call can be accessed in the "Events" section on the "Investors & Media" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.

On November 7, 2017 Aptose Biosciences Inc. (Aptose) (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that it will release its financial results for the quarter ended September 30, 2017 on Tuesday, November 14, 2017 after the close of the market (Press release, Aptose Biosciences, NOV 7, 2017, View Source [SID1234521626]). The company intends to host a conference call the same day at 5:00 p.m. ET to discuss the financial results.

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Participants can access the conference call by dialing (844) 882-7834 (North American toll free number) and (574) 990-9707 (International) and using passcode 98696700. The conference call can also be accessed here and will be available through a link on the Investor Relations section of Aptose’s website at ir.aptose.com. Please log onto the webcast at least 10 minutes prior to the start of the call to ensure time for any software downloads that may be required. An archived version of the webcast along with a transcript will be available on the company’s website for 30 days. An audio replay of the webcast will be available approximately two hours after the conclusion of the call for 7 days by dialing (855) 859-2056, using the passcode 98696700.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended September 30, 2017 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On November 7, 2017 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the third quarter ended September 30, 2017 (Press release, BioCryst Pharmaceuticalsa, NOV 7, 2017, View Source [SID1234521627]).

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"Now that we have completed our end of Phase 2 regulatory interactions with the FDA and EMA and have agreement on the requirements for marketing authorization applications of BCX7353, we are focused on executing the Phase 3 program to support NDA and MAA filings in 2019," said Jon P. Stonehouse, President & Chief Executive Officer. "We expect to start the single required Phase 3 efficacy and the long-term safety trials in first quarter 2018."

Third Quarter Financial Results

For the three months ended September 30, 2017, revenues increased to $8.8 million from $7.8 million in the third quarter of 2016. The increase in revenue was primarily due to a $5.0 million milestone payment associated with the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for RAPIVAB (peramivir injection), extending its availability for the treatment of acute uncomplicated influenza to pediatric patients two years and older, and the recognition of $1.5 million of peramivir product sales to the Company’s commercial partner, Green Cross Corporation. These increases were offset by a $3.1 million decrease in RAPIACTA royalties primarily due to lower government stockpiling sales by the Company’s commercial partner in Japan, Shionogi & Co. Ltd. (Shionogi), and lower collaboration revenue under U.S. Government development contracts.

Research and Development (R&D) expenses for the third quarter of 2017 increased to $17.5 million from $14.1 million in the third quarter of 2016, primarily due to increased spending on the Company’s hereditary angioedema (HAE) portfolio, including the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial. These increases were offset by a decrease in the Company’s galidesivir expenses under U.S. Government development contracts.

General and administrative (G&A) expenses for the third quarter of 2017 increased to $3.3 million compared to $2.8 million of expense in the third quarter of 2016. The increase was primarily due to the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial.

Interest expense was $2.1 million in the third quarter of 2017 as compared to $1.5 million in the third quarter of 2016, an increase related primarily to the September 2016 closing of a $23 million senior credit facility. Also, a $84,000 mark-to-market gain on the Company’s foreign currency hedge was recognized in the third quarter of 2017, as compared to a $931,000 mark-to-market loss in the third quarter of 2016. These changes result from periodic changes in the U.S. dollar/Japanese yen exchange rate. During the third quarter of 2017, the Company also realized a currency gain of $45,000 from the exercise of a U.S. Dollar/Japanese yen currency option within its foreign currency hedge.

The net loss for the third quarter of 2017 was $15.1 million, or $0.18 per share, compared to a net loss of $11 .5 million, or $0.16 per share, for the third quarter 2016.

Cash, cash equivalents and investments totaled $169.3 million at September 30, 2017, and reflect an increase from $65.1 million at December 31, 2016. Net operating cash use for the third quarter of 2017 was $10.6 million, and was $31.6 million for the first nine months of 2017, which excludes net proceeds from the March 2017 ($47.8 million) and September 2017 ($85.8 million) public offerings.

Year to Date Financial Results

For the nine months ended September 30, 2017, revenues increased to $21.3 million from $17.4 million in the first nine months of 2016. The increase in revenue was primarily due to $7.0 million of milestone payments associated with the Canadian regulatory and FDA sNDA approvals of RAPIVAB, and to a lesser extent a $1.2 million increase in royalty revenue from Shionogi & Co. Ltd., Green Cross Corporation and Seqirus. The increase in royalty revenue was largely the result of continued Japanese Government stockpiling of RAPIACTA. Future government stockpiling orders are difficult to predict, as they are subject to the relevant appropriation and stockpiling processes. These revenue increases were offset by a $5.5 million decrease in collaboration revenue under U.S. Government development contracts.

R&D expenses for the nine months of 2017 increased to $50.0 million from $48.9 million in the first nine months of 2016, primarily due to the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial. These increases were offset by a decrease in galidesivir expenses under U.S. Government development contracts.

G&A expenses for the nine months of 2017 increased to $9.2 million compared to $8.7 million in the first nine months of 2016. The increase was due to the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial.

In the nine months of 2017 and 2016, interest expense was $6.3 million and $4.4 million, respectively. The increase in interest expense was related primarily to the September 2016 closing of a $23 million senior credit facility. A $1.9 million mark-to-market loss on the Company’s foreign currency hedge was recognized in the first nine months of 2017, as compared to a $7.4 million mark-to-market loss in the first nine months of 2016. These losses result from periodic changes in the U.S. dollar/Japanese yen exchange rate. During 2017 and 2016, we also realized currency gains of $966,000 and $811,000, respectively, from the exercise of a U.S. Dollar/Japanese yen currency option within our foreign currency hedge.

The net loss for the nine months of 2017 was $46.2 million, or $0.58 per share, compared to a net loss of $50.6 million, or $0.69 per share for the same period last year.

Clinical Development Update & Outlook

In the fourth quarter, BioCryst completed end of Phase 2 regulatory interactions with the FDA and European Medicines Agency (EMA) resulting in finalizing the marketing authorization requirements, including agreement on the design of a single Phase 3 clinical trial and the details regarding a long-term safety trial.

On November 1, 2017, the FDA granted orphan drug designation to BCX7353 for the prevention and treatment of angioedema attacks in patients diagnosed with HAE.

On September 5, BioCryst announced positive final results from its Phase 2 APeX-1 clinical trial in HAE. APeX-1 was a 3-part dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered once-daily BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE patients.

On September 15, BioCryst announced the completion of an underwritten public offering of 17,864,078 shares of its common stock, including 2,330,097 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares. The gross proceeds from this offering, including from the shares sold pursuant to the underwriters’ option to purchase additional shares, were $92 million before deducting underwriting discounts and commissions and other estimated offering expenses.

On September 21, BioCryst announced that the U.S. FDA approved a sNDA for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients two years and older who have been symptomatic for no more than two days.
Financial Outlook for 2017

Based upon development plans and our awarded government contracts, BioCryst expects its 2017 net operating cash use to be in the upper half of its previously disclosed range of $30 to $50 million, and its 2017 operating expenses to be in the upper half of its previously disclosed range of $53 to $73 million. Our operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the Company’s stock, as well as by the vesting of the Company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst’s leadership team will host a conference call and webcast Tuesday, November 7, 2017 at 11:00 a.m. Eastern Time to discuss these financial results and recent corporate developments. To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed by logging onto www.BioCryst.com. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.

About BCX7353

Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 was generally safe and well tolerated in the recently completed Phase 2 APeX-1 clinical trial for the prophylaxis of angioedema attacks in patients with HAE and in clinical pharmacology studies in healthy volunteers.

About RAPIVAB (peramivir injection)

Approved by FDA in December 2014, RAPIVAB (peramivir injection) is an intravenous viral neuraminidase inhibitor approved for the treatment of acute uncomplicated influenza in patients two years and older who have been symptomatic for no more than two days. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit View Source to learn more.