On February 27, 2018 vTv Therapeutics Inc. (Nasdaq:VTVT) reported a corporate update and financial and operational results for the fourth quarter and full year that ended December 31, 2017 (Press release, vTv Therapeutics, FEB 27, 2018, View Source;p=RssLanding&cat=news&id=2335134 [SID1234524269]).

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"We made tremendous progress across the spectrum of our Alzheimer’s and diabetes programs this past year, and look forward to continuing this momentum in 2018 as we anticipate reporting topline results in April from Part A of our Phase 3 STEADFAST study of azeliragon in patients with mild Alzheimer’s disease," said Steve Holcombe, president and CEO of vTv Therapeutics. "Our unique and holistic approach to targeting Alzheimer’s through the receptor for advanced glycation endproducts (RAGE) antagonist addresses three major pathologies believed to contribute to the disease: transport of a-beta to the brain, inflammation and the phosphorylation of tau protein. We’re hopeful that results from the study will be a step toward finding a much-needed therapy for the Alzheimer’s community and the millions of people suffering from this devastating disease."

Fourth Quarter 2017 Highlights

vTv Therapeutics Initiates Phase 1b/2 Study as Part of Industry Partnership with the Juvenile Diabetes Research Foundation (JDRF)

Conducted with support from JDRF, the leading global organization funding type 1 diabetes (T1D) research, vTv Therapeutics initiated simplici-T1, an adaptive Phase1b/2 study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of vTv Therapeutics’ liver-selective glucokinase activator, TTP399, in type 1 diabetes. The study will evaluate whether TTP399 is well-tolerated when administered as an add-on to insulin therapy and can improve daily glucose profiles and HbA1c in people living with T1D.

vTv Therapeutics and Hangzhou Zhongmei Huadong Pharmaceutical Co. Enter Licensing Agreement for GLP-1r Diabetes Program

vTv Therapeutics successfully entered into a licensing agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., one of the largest pharmaceutical companies in China, for rights to develop and commercialize vTv Therapeutics’ GLP-1r agonist program, including TTP273, in China and other Pacific Rim countries. vTv Therapeutics received an $8 million upfront payment and is eligible for up to an additional $75 million in milestone payments related to development, regulatory and commercial milestones. In addition, vTv Therapeutics will be eligible to receive royalty payments on sales of commercialized products in the licensed territories. vTv will conduct a Phase 2 multi-region clinical trial, including sites in both the United States and China, to investigate the safety and efficacy of a lower dose of TTP273 in patients with type 2 diabetes.

vTv Therapeutics and Reneo Pharmaceuticals Enter Licensing Agreement for PPAR-delta Program

vTv Therapeutics granted Reneo Pharmaceuticals exclusive worldwide rights to research, develop and commercialize vTv Therapeutics’ selective peroxisome proliferator-activated receptor delta (PPAR-delta) program, including HPP593, in a global licensing agreement. Under the terms of the agreement, vTv Therapeutics received an upfront payment and is eligible to receive future development and commercialization milestones as well as royalties on sales of approved products. vTv Therapeutics also received shares of Reneo Pharmaceuticals’ common stock.

vTv Therapeutics Hosts Key Opinion Leader (KOL) Event on Current State of Clinical Development in Alzheimer’s Disease

vTv Therapeutics hosted a KOL presentation focused on the current state of clinical development in Alzheimer’s disease. The event featured two speakers with extensive experience in Alzheimer’s research and care: Dr. Howard Fillit, founding executive director and chief scientific officer of Alzheimer’s Drug Discovery Foundation, clinical professor of geriatric medicine, palliative care and neuroscience at Mt. Sinai School of Medicine; and Dr. Mary Sano, associate dean for clinical research, professor of psychiatry, founding member and director of the Alzheimer’s Disease Research Center at Mt. Sinai School of Medicine. vTv Therapeutics provided a brief overview of the company’s ongoing Phase 3 clinical development program for azeliragon, an orally bioavailable small molecule RAGE antagonist for patients with mild Alzheimer’s disease.

Upcoming Anticipated Milestones

vTv Therapeutics anticipates reporting topline data from Part A of the company’s Phase 3 STEADFAST Study in April 2018. Data from Part B are expected to read out in early 2019. The STEADFAST study is a single protocol within which vTv Therapeutics is conducting two statistically independent, identical, randomized, double-blind, placebo-controlled trials investigating the efficacy of azeliragon as a potential treatment of mild Alzheimer’s disease.

Shelf Registration on Form S-3

Today the Company filed a S-3 Registration Statement with the Securities and Exchange Commission to register Class A Common Stock. The Company has no current plans to issue securities under the Registration Statement.

Fourth Quarter 2017 Financial Results

Cash Position: Cash and cash equivalents as of December 31, 2017, were $11.8 million compared to $20.5 million as of September 30, 2017.
R&D Expenses: Research and development expenses were $10.1 million in the fourth quarter of 2017, compared to $9.0 million in the third quarter of 2017. The increase in research and development expense was primarily driven by increased enrollment in the open-label extension trial and higher consulting costs incurred related to the STEADFAST Study.
G&A Expenses: General and administrative expenses were $2.9 million and $2.6 million, for the fourth and third quarters of 2017, respectively. The increase in general and administrative cost was primarily due to the higher professional service fees incurred in the fourth quarter of 2017 related to our license agreements entered into in December 2017.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $14.6 million for the fourth quarter of 2017 compared to net loss before non-controlling interest of $12.4 million for the third quarter of 2017.
Net Loss per Share: GAAP net loss per share was $0.44 and $0.38 for the three months ended December 31, 2017 and September 30, 2017, respectively, based on weighted-average shares of 9.7 million in each period. Non-GAAP net loss per fully exchanged share was $0.44 and $0.38 for the three months ended December 31, 2017 and September 30, 2017, respectively, based on non-GAAP fully exchanged weighted-average shares of 32.8 million in each period.

Full Year 2017 Financial Results

R&D Expenses: Research and development expenses were $39.6 million in 2017, compared to $45.7 million in 2016. The decrease in research and development expense was primarily driven by decreases in clinical trial costs for TTP399 and TTP273 as both the AGATA and LOGRA studies were completed in 2016. Additionally, we saw decreases in the expense for azeliragon as a result of the completion of drug-drug interaction and other supporting studies in 2016 which were partially offset by increases in cost related to continuing enrollment in the open-label extension trial and increased cost of consultants engaged to assist with the STEADFAST Study.
G&A Expenses: General and administrative expenses were $11.3 million and $9.9 million, for the 2017 and 2016, respectively. The increase in general and administrative cost was primarily due to the higher professional service fees incurred in 2017 related to our license agreements entered into in December 2017 and increased compensation cost related to the grant of additional share-based compensation awards as well as the impact of additional personnel hired in both years.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $54.6 million for 2017 compared to net loss before non-controlling interest of $55.4 million for 2016.
Net Loss per Share: GAAP net loss per share was $1.67 and $1.71 for 2017 and 2016, respectively, based on weighted-average shares of 9.7 million and 9.5 million in each period, respectively. Non-GAAP net loss per fully exchanged share was $1.67 and $1.69 for 2017 and 2016, respectively, based on non-GAAP fully exchanged weighted-average shares of 32.8 million in each period.

vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
(in thousands)

December 31, September 30,
2017 2017
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 11,758 $ 20,488
Restricted cash and cash equivalents 162 281
Accounts receivable, net 8,000 —
Prepaid expenses and other current assets 442 725
Total current assets 20,362 21,494
Restricted cash and cash equivalents, long-term 2,500 —
Property and equipment, net 283 310
Long-term investments 2,480 —
Long-term deposits 2,292 2,251
Total assets $ 27,917 $ 24,055
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit
Current liabilities:
Accounts payable and accrued expenses $ 13,901 $ 10,120
Deferred revenue 8,757 —
Current portion of notes payable 4,271 2,083
Total current liabilities 26,929 12,203
Notes payable 15,316 17,228
Deferred revenue, net of current portion 4,497 —
Warrant liability, related party 492 —
Other liabilities 290 285
Total liabilities 47,524 29,716
Commitments and contingencies
Redeemable noncontrolling interest 131,440 130,642
Stockholders’ deficit:
Class A Common Stock 97 97
Class B Common Stock 232 232
Additional paid-in capital 127,682 127,036
Accumulated deficit (279,058 ) (263,668 )
Total stockholders’ deficit attributable to vTv Therapeutics Inc. (151,047 ) (136,303 )
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit $ 27,917 $ 24,055


vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations – Unaudited
(in thousands, except per share data)

Three Months Ended
September 30,
December 31, 2017 2017
Revenue $ 233 $ 15
Operating expenses:
Research and development 10,068 8,989
General and administrative 2,937 2,567
Total operating expenses 13,005 11,556
Operating loss (12,772 ) (11,541 )
Interest income 22 35
Interest expense (852 ) (849 )
Other expense, net (190 ) —
Loss before income taxes and noncontrolling interest (13,792 ) (12,355 )
Income tax provision 800 —
Net loss before noncontrolling interest (14,592 ) (12,355 )
Less: net loss attributable to noncontrolling interest (10,281 ) (8,705 )
Net loss attributable to vTv Therapeutics Inc. $ (4,311 ) $ (3,650 )

Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted
$ (0.44 ) $ (0.38 )

Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted
9,693,254 9,693,254


vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)

Three Months Ended For the Year Ended
December 31, December 31,
(Unaudited)
2017 2016 2017 2016
Revenue $ 233 $ 38 $ 291 $ 634
Operating expenses:
Research and development 10,068 11,099 39,640 45,748
General and administrative 2,937 2,252 11,333 9,906
Total operating expenses 13,005 13,351 50,973 55,654
Operating loss (12,772 ) (13,313 ) (50,682 ) (55,020 )
Interest income 22 20 117 87
Interest expense (852 ) (394 ) (3,092 ) (398 )
Other expense, net (190 ) (24 ) (190 ) (22 )
Loss before income taxes and noncontrolling interest (13,792 ) (13,711 ) (53,847 ) (55,353 )
Income tax provision 800 — 800 —
Net loss before noncontrolling interest (14,592 ) (13,711 ) (54,647 ) (55,353 )
Less: net loss attributable to noncontrolling interest (10,281 ) (9,661 ) (38,503 ) (39,001 )
Net loss attributable to vTv Therapeutics Inc. $ (4,311 ) $ (4,050 ) $ (16,144 ) $ (16,352 )

Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted
$ (0.44 ) $ (0.42 ) $ (1.67 ) $ (1.71 )

Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted
9,693,254 9,693,254 9,693,254 9,545,527

On February 27, 2018 Nordic Nanovector ASA (OSE: NANO) reported results for the fourth quarter and full year 2017 (Press release, Nordic Nanovector, FEB 27, 2018, View Source [SID1234553510]). A presentation by the company’s team will take place today in Oslo at 08:30 CET, see details below.

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Nordic Nanovector made significant progress during 2017, continuing the strong positive momentum started in 2016. The company has advanced the clinical development programme for Betalutin into its pivotal PARADIGME trial and expanded the knowledge base from which it intends to develop a successful commercialisation strategy for the candidate. The company also advanced its partnered early stage programmes aimed at creating a pipeline of novel targeted therapies for haematological cancers.

Updated clinical data from the Phase 1/2a LYMRIT 37-01 trial presented at ASH (Free ASH Whitepaper) in December continue to highlight Betalutin’s strong clinical profile as a single agent for treating patients with relapsed/refractory follicular lymphoma (R/R FL). Nordic Nanovector initiated its pivotal PARADIGME trial with Betalutin in the fourth quarter as planned and the study is currently open for patient enrolment. PARADIGME is a global randomized Phase 2b study comparing two Betalutin dosing regimens in third line (3L) FL patients who are refractory to standard-of-care anti-CD20-based therapy (including rituximab). Nordic Nanovector is targeting initial data read-outs from the study and subsequent filing in the second half of 2019 for marketing approval.

The final design for ARCHER-1 was completed and the trial will open for enrolment once regulatory approval has been received. The trial will be the first to combine Betalutin with rituximab in second line (2L) FL patients, based on promising preclinical data showing strong synergy between the two agents.

Recruitment into the Phase 1 study in diffuse large B-Cell lymphoma (DLBCL) remains on track, and a Phase 1 trial of Humalutin is ready to start with the first patient expected to be dosed in the second half of 2018.

Luigi Costa, CEO of Nordic Nanovector, comments: "In 2017 we continued with a strong momentum and have delivered on several important milestones. We continue to show strong clinical data that consistently reinforce Betalutin’s potential as one of the most promising new treatments for indolent non-Hodgkin Lymphoma (iNHL). We have transitioned the company to the next phase by starting PARADIGME, the pivotal Phase 2b study with the intent to generate the data for regulatory submission in 3L FL. I am very pleased with the good progress towards the first trial of Betalutin in combination with standard of care anti-CD20 therapy (rituximab) in 2L FL (ARCHER-1). Our focus during 2018 will be to drive recruitment into our leading clinical studies with the objective of taking Betalutin to patients as fast as possible while we progress in development of our commercial strategy."

Operational Highlights Q4’17

• Updated results from LYMRIT 37-01 Phase 1/2a trial presented at ASH (Free ASH Whitepaper) show Betalutin’s strong clinical profile in patients with R/R iNHL

o Significant anti-tumour activity observed: 90% of patients (n=59) had a reduction in tumour size

o ORR of 60% and CR of 24% for all evaluable iNHL patients

o Highly active in target population of FL patients with two or more prior therapies (3L FL) with 66% ORR and 25% CR

o Median duration of response of 13.3 months for FL patients receiving 40 mg lilotomab pre-dosing followed by 15 MBq/kg Betalutin (n=17); median duration of response of 22.9 months for patients with a CR (n=7)

o Promising early data from second dosing regimen (Arm 4 – 100 mg/m2 lilotomab/20 MBq/kg Betalutin)

o Well tolerated with predictable and manageable safety profile

• Phase 1/2a study LYMRIT 37-01 recruitment completed with 74 patients enrolled

• Pivotal Phase 2b PARADIGME trial initiated to investigate Betalutin in patients with 3L R/R FL

o Study opened for patient enrolment

o Two promising dosing regimens to be evaluated (40mg lilotomab/15 MBq/kg Betalutin and 100 mg/m2 lilotomab/20 MBq/kg Betalutin)

• Finalised design for ARCHER-1, trial aims to investigate Betalutin in combination with rituximab in 2L FL

o Trial will open for patient enrolment once regulatory approvals has been received

• Results from extensive research aimed at supporting market strategy for Betalutin demonstrate clear commercial opportunities

• Rosemarie Corrigan appointed to the Executive management team as Chief Quality Officer

Events after Q4’17

• Malene Brondberg appointed as Vice President, IR and Corporate Communications

Financial Highlights Q4 and FY’17

(Figures in brackets = same period 2016 unless otherwise stated)

• Revenues for the fourth quarter amounted to NOK 0.1 million (NOK 0.1 million). Revenues for the full year 2017 were NOK 0.3 million (NOK 0.3 million).

• Total operating expenses for the fourth quarter were NOK 102.0 million (NOK 65.4 million). Total operating expenses for the full year 2017 amounted to NOK 316.8 million (NOK 216.7 million).

• Comprehensive loss for the fourth quarter amounted to NOK 87.6 million (loss of NOK 59.3 million). Comprehensive loss for the full year 2017 was NOK 295.6 million (NOK 235.8 million).

• Cash and cash equivalents amounted to NOK 756.6 million at the end of December 2017 (NOK 1 018.2 million).

Outlook

Nordic Nanovector aspires to become a leader in the field of Precision Therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, is developing a well differentiated, competitive, clinical profile for R/R FL, based on the promising preliminary results from the LYMRIT 37-01 Phase 1/2a clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with the goal to have the initial data read-outs from the study and subsequent filing in the second half of 2019 for marketing approval.

Nordic Nanovector intends to maximize the value of Betalutin across other stages of FL, NHL and other haematological cancer indications. A further element of the company’s strategy is to selectively extend its pipeline of novel targeted biopharmaceutical candidates to support future growth.

Management will continue to focus its efforts on the efficient execution of its plans and to meet clinical and pre-commercialisation milestones. The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Current cash resources are expected to be sufficient until first regulatory filing of Betalutin in 3L R/R FL and to advance other key programmes

Presentation and webcast – Fourth Quarter and Full Year 2017 results

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2017 from 7:00 am CET today.

On February 27, 2018 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, BioCryst Pharmaceuticalsa, FEB 27, 2018, View Source [SID1234524193]).

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"Our team made significant progress in 2017 and we are off to a strong start in 2018," said Jon P. Stonehouse, President & Chief Executive Officer. "We are keenly focused on continuing that momentum by advancing our pipeline, adding additional programs and driving our BCX7353 oral prophylactic program toward approval and launch. We are on track to report top-line results from the APeX-2 pivotal trial of BCX7353 and to initiate a Phase 1 clinical trial for our recently unveiled ALK2 inhibitor program for treating FOP in the first half of 2019."

Mr. Stonehouse continued, "In January, we announced our proposed merger with Idera Pharmaceuticals, Inc. that we believe will build greater and more sustainable value for the benefit of stockholders as well as patients with rare diseases beyond what we could achieve alone. The BioCryst Board determined this combination was compelling from both a strategic and financial perspective following a careful evaluation of a range of strategies to enhance long-term stockholder value. The transaction will create a leading rare disease company with a robust pipeline including two promising Phase 3 programs and combines synergistic discovery engines that will not only expand the number of rare diseases we can target but create meaningful opportunities for differentiation in the market through joint small molecule and oligo treatments. Importantly, joining with Idera will also enable us to achieve cost synergies and increase our financial strength and flexibility."

Fourth Quarter Financial Results

For the three months ended December 31, 2017, total revenues were $3.9 million, compared to $9.0 million in the fourth quarter of 2016. The decrease in revenue was primarily due to the recognition of $2.3 million of RAPIVAB product sales to commercial partners in 2016 that did not recur in 2017 and approximately a $2.5 million decline in collaborative revenue in 2017, associated with a decrease in development activity under U.S. Government development contracts.

Research and Development (R&D) expenses for the fourth quarter of 2017 increased to $16.9 million from $12.2 million in the fourth quarter of 2016, primarily due to additions in R&D personnel, as well as increased spending to advance the Company’s hereditary angioedema (HAE) portfolio. These increases were partially offset by a decrease in the Company’s galidesivir development expenses in 2017.

General and administrative (G&A) expenses for the fourth quarter of 2017 increased to $4.7 million, compared to $2.6 million in the fourth quarter of 2016. The increase was primarily due to approximately $1.5 million of merger-related costs associated with the Company’s previously announced definitive merger agreement with Idera Pharmaceuticals, Inc. (Idera).

Interest expense was $2.2 million in the fourth quarter of 2017, compared to $2.1 million in the fourth quarter of 2016. Also, a $71,000 mark-to-market gain on the Company’s foreign currency hedge was recognized in the fourth quarter of 2017, as compared to a $5.7 million mark-to-market gain in the fourth quarter of 2016. These changes result from periodic changes in the U.S. dollar/Japanese yen exchange rate.

Net loss for the fourth quarter of 2017 was $19.5 million, or $0.20 per share, compared to a net loss of $4.5 million, or $0.06 per share, for the fourth quarter 2016.

Full Year 2017 Financial Results

For the year ended December 31, 2017, total revenues decreased to $25.2 million from $26.4 million in 2016. The decrease in 2017 revenue was primarily due to lower collaborative revenue under U.S. Government development contracts as well as lower revenue from product sales to corporate partners. These decreases were largely offset by $7.0 million in milestone payments associated with U.S. pediatric and Canadian regulatory approvals of RAPIVAB.

R&D expenses for 2017 increased to $67.0 million from $61.0 million in 2016, primarily due to increased spending on the Company’s HAE program, partially associated with the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial, as well as an increase in R&D personnel. These increases were partially offset by a decrease in galidesivir development expenses under U.S. Government development contracts.

G&A expenses for 2017 increased to $13.9 million, compared to $11.3 million in 2016. The increase was due primarily to the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial as well as merger-related costs associated with the Company’s definitive merger agreement with Idera.

Interest expense was $8.6 million in 2017, compared to $6.5 million in 2016. The increase in interest expense was due primarily to the closing of the Company’s $23 million senior credit facility in September 2016. A $1.8 million mark-to-market loss on the Company’s foreign currency hedge was recognized in 2017, as compared to a $1.7 million mark-to-market loss in 2016. These losses result from periodic changes in the U.S. dollar/Japanese yen exchange rate. During 2017 and 2016, the Company also realized currency gains of $966,000 and $811,000, respectively, from the exercise of a U.S. Dollar/Japanese yen currency option within its foreign currency hedge.

Net loss for 2017 was $65.8 million, or $0.78 per share, compared to a net loss of $55.1 million, or $0.75 per share for the same period last year.

Cash, cash equivalents and investments totaled $159.0 million at December 31, 2017, and reflect an increase from $65.1 million at December 31, 2016. Net operating cash use for 2017 was $41.8 million, which excludes $134.0 million of net proceeds from the March and September 2017 public offerings.

Clinical Development Update & Outlook

Enrollment in the 750 mg cohort of the Zenith-1 proof-of-concept Phase 2 clinical trial of a liquid formulation of BCX7353 for treatment of acute angioedema attacks in HAE has been completed and the 500 mg cohort is currently enrolling. We expect to report top-line results from the first cohort in the second half of 2018.

On January 5, 2018, BioCryst announced that it had advanced a discovery program exploring activin receptor-like kinase-2 (ALK2) inhibitors for treatment of Fibrodysplasia Ossificans Progressiva (FOP) into Investigational New Drug Application (IND) enabling nonclinical development. The Company’s optimized lead candidates, BCX9250 and BCX9499, are projected to enter Phase 1 clinical trials during the first half of 2019.

On January 22, 2018, BioCryst and Idera jointly announced the signing of a definitive merger agreement to create a company focused on the development and commercialization of medicines to serve patients suffering from rare diseases. The combined company will be renamed upon closing, and will be led by Vincent Milano, CEO of Idera. Jon Stonehouse will serve as a member of the Board of Directors. The transaction is subject to approval by the stockholders of both companies, as well as the satisfaction of customary closing conditions. The transaction is expected to be completed by the end of the second quarter of 2018.
Financial Outlook for 2018

Based upon development plans and the Company’s awarded government contracts, on a stand-alone basis, BioCryst expects its 2018 net operating cash use to be in the range of $67 to $90 million, and its 2018 operating expenses to be in the range of $85 to $110 million. The Company’s 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.

Company and Idera File Joint Preliminary Proxy Statement / Prospectus and Updated Merger Presentation

The Company also today provided an updated investor presentation regarding the proposed merger with Idera Pharmaceuticals, which was announced on January 22, 2018. The presentation and a joint preliminary proxy statement / prospectus were filed today with the U.S. Securities and Exchange Commission (the "SEC"), and both can be accessed by visiting the "Investors" section of the Company’s website at www.BioCryst.com.

Conference Call and Webcast

BioCryst’s leadership team will host a conference call and webcast Tuesday, February 27, 2018 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 live or in archived form in the "Investors" section of the Company’s website at www.BioCryst.com. An accompanying slide presentation may also be accessed via the BioCryst website. 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 has been generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is also conducting the ongoing ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the treatment of acute angioedema attacks.

On February 27, 2018 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and twelve months ended December 31, 2017 and highlighted recent corporate progress (Press release, Heron Therapeutics, FEB 27, 2018, View Source [SID1234524237]).

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Recent Corporate Progress

CINV Franchise

SUSTOL Sales. Net product sales of SUSTOL (granisetron) extended-release injection for the three months ended December 31, 2017 were $10.1 million, up 17% from the net product sales for the three months ended September 30, 2017 of $8.6 million. SUSTOL net product sales for the twelve months ended December 31, 2017 were $30.8 million, versus guidance of $25 million to $30 million.
2018 CINV Sales Guidance. Net product sales guidance for full-year 2018 for the CINV franchise is $60 million to $70 million.
Permanent J-Code Now Effective. On January 1, 2018,a product-specific billing code, or permanent J-code, for SUSTOL became available. The new J-code was assigned by the Centers for Medicare and Medicaid Services (CMS) and will help simplify the billing and reimbursement process for prescribers of SUSTOL.
CINVANTI Now Available. In November 2017, the U.S. Food and Drug Administration (FDA) approved the Company’s New Drug Application (NDA) for CINVANTI (aprepitant) injectable emulsion, the first and only polysorbate 80-free intravenous (IV) formulation of a neurokinin-1 (NK1) receptor antagonist indicated for the prevention of acute and delayed CINV. CINVANTI became commercially available in the United States on January 4, 2018.

Pain Management Franchise

Enrollment Complete in Phase 3 Pivotal Trials for HTX-011 in Postoperative Pain. Heron completed enrollment in its two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair. Heron anticipates reporting top-line results in the first half of 2018 and expects to file an NDA with the FDA in the second half of 2018.

"2017 was an excellent year for Heron, with significant progress in both our CINV and pain management franchises," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "2018 should be an equally exciting year as we look forward to reporting top-line pivotal Phase 3 data and filing an NDA for HTX-011, while continuing to ramp up net product sales for our CINV franchise."

Financial Results

Net product sales of SUSTOL for the three and twelve months ended December 31, 2017 were $10.1 million and $30.8 million, respectively. Heron commenced commercial sales of SUSTOL in October 2016. Net product sales of SUSTOL for both the three and twelve months ended December 31, 2016 were $1.3 million.

Heron’s net loss for the three and twelve months ended December 31, 2017 was $62.5 million and $197.5 million, or $1.09 per share and $3.65 per share, respectively, compared to a net loss of $48.0 million and $173.1 million, or $1.22 per share and $4.56 per share, respectively, for the same periods in 2016. Net loss for the three and twelve months ended December 31, 2017 included non-cash, stock-based compensation expense of $6.9 million and $30.5 million, respectively, compared to $7.3 million and $26.0 million, respectively, for the same periods in 2016.

As of December 31, 2017, Heron had $172.4 million in cash, cash equivalents and short-term investments, which included net proceeds of $142.6 million from an underwritten public offering of common stock completed in December 2017. Net cash used for operating activities for the three and twelve months ended December 31, 2017 was $47.1 million and $170.3 million, respectively, compared to net cash used for operating activities of $38.5 million and $134.1 million, respectively, for the same periods in 2016.

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. The Phase 2 development program for HTX-011 was designed to target the many patients undergoing a wide range of surgeries who experience significant postoperative pain. Heron completed enrollment in its two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair and anticipates reporting top-line results in the first half of 2018 and expects to file an NDA with the FDA in the second half of 2018.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI is indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. CINVANTI is the first intravenous (IV) formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce CINV in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI does not contain polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain. FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion.

Please see Full Prescribing Information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).

On February 27, 2018 Integra LifeSciences Holdings Corporation (NASDAQ:IART) today reported financial results for the fourth quarter and full-year ended December 31, 2017 (Press release, IsoTis, FEB 27, 2018, View Source [SID1234524240]).

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Highlights:

The Company completed the acquisition of Codman Neurosurgery, the largest in its history, on October 2, 2017;

Reported revenue for the full-year 2017 was $1,188.2 million, an increase of 19.8%, or $196.2 million over the prior year; acquisitions contributed $162.1 million to the full year, while organic sales were higher by 4.6% over the prior year;

Fourth quarter revenue was $368.6 million, an increase of 44.2%, or $112.9 million over the prior year quarter; acquisitions contributed $103.3 million to the fourth quarter, while organic sales were higher by 5.8% over the prior year quarter;

Fourth quarter GAAP earnings per diluted share amounted to $0.56, a 60% increase over the prior year period, and includes a net tax benefit of $37.9 million, or $0.47 per diluted share, associated with the U.S. Tax Cuts and Jobs Act;

Fourth quarter adjusted earnings per diluted share amounted to $0.64, a 23% increase over the prior year period;

Full-year 2017 GAAP earnings per diluted share amounted to $0.82, a 12.8% decrease over the prior year; Full-year adjusted earnings per diluted share amounted to $1.94, a 10.2% increase over the prior year, which represents the fourth consecutive year of double-digit adjusted earnings per diluted share growth; and

The Company now expects to be at the high-end of its previously provided full-year 2018 revenue guidance range of $1.46 billion to $1.48 billion, largely due to favorable foreign currency exchange rates. The Company expects full-year GAAP earnings per diluted share to be in a range of $0.60 to $0.70, and also expects full-year adjusted earnings per diluted share to be at the high-end of its previously provided range of $2.25 to $2.35, due to a lower expected tax rate associated with the U.S. Tax Cuts and Jobs Act.

Total revenues for the full year 2017 were $1,188.2 million, an increase of $196.2 million, or 19.8%, over the prior year. Total revenues for the fourth quarter were $368.6 million, an increase of $112.9 million, or 44.2%, over the fourth quarter of 2016.

Organic revenues for the full year 2017, as set forth in the attached reconciliation, increased 4.6% over the prior year, while fourth quarter organic revenues were higher by 5.8% over the fourth quarter of 2016.

"2017 was a transformative year for Integra. We closed the two largest acquisitions in the Company’s history, expanded our regenerative portfolio with new, innovative products and successfully executed the global launch of CUSA Clarity, a significant upgrade to our tissue ablation platform," said Peter Arduini, Integra’s President and Chief Executive Officer. "We look forward to 2018 and another year of strong revenue growth, margin expansion and improving profitability."

The Company reported GAAP net income of $64.7 million, or $0.82 per diluted share, for the full year 2017, compared to GAAP net income of $74.6 million, or $0.94 per diluted share, in 2016.

The Company reported GAAP net income of $44.4 million, or $0.56 per diluted share, in the fourth quarter of 2017, compared to GAAP net income of $28.2 million, or $0.35 per diluted share, in the fourth quarter of 2016.

In 2017, the U.S. Tax Cuts and Jobs Act resulted in the Company recognizing a net income tax benefit of $37.9 million. This includes a $43.4 million benefit from the re-measurement of deferred taxes as a result of the reduction in U.S. corporate tax rates from 35% to 21%, offset by a one-time toll charge of $5.5 million imposed on deemed repatriation of foreign untaxed earnings.

Adjusted measures discussed below are computed with the adjustments to GAAP reporting set forth in the attached reconciliation.

Adjusted EBITDA for the full year 2017 was $269.5 million, an increase of $37.8 million, over the prior year. For the full year 2017, adjusted EBITDA as a percentage of revenue declined from 23.4% in 2016 to 22.7% in 2017, largely resulting from the dilution of the Derma Sciences acquisition and higher sales channel investments.

Adjusted EBITDA for the fourth quarter of 2017 was $88.7 million, an increase from $66.5 million in the fourth quarter of the prior year. For the fourth quarter of 2017, adjusted EBITDA as a percentage of revenue was 24.1%, compared to 26.0% in the prior year period.

Adjusted net income for the full year 2017 was $153.4 million, or $1.94 per diluted share, compared to $135.3 million, or $1.76 per diluted share, in 2016. Adjusted net income for the fourth quarter of 2017 was $51.0 million, or $0.64 per diluted share, compared to adjusted net income of $40.7 million, or $0.52 per diluted share, in the fourth quarter of 2016.

For the year ended December 31, 2017, cash flows from operations totaled $114.5 million. Capital expenditures were $43.5 million. Adjusted free cash flow conversion for the trailing twelve months ended December 31, 2017 was 46.3% versus 82.7% for the twelve months ended December 31, 2016, due to significant one-time cash outlays associated with the acquisition integrations. In the fourth quarter of 2017, the Company generated $11.6 million of cash flows from operations, and incurred capital expenditures of $13.7 million.

Outlook for 2018

The Company is reiterating its full-year 2018 revenue guidance in the range of $1.46 billion to $1.48 billion, and now expects to be at the high end of the range due primarily to more favorable foreign currency rates.

The Company expects GAAP earnings per diluted share for the full year to be between $0.60 and $0.70, and adjusted earnings per diluted share to be at the high end of its previously provided range of $2.25 to 2.35, due primarily to a lower expected tax rate from the U.S. Tax Cuts and Jobs Act.

"Given our strong close to the year, the momentum in our businesses, and the benefit of a lower tax rate, we remain confident that we will deliver 5% organic growth and adjusted earnings per share at the high-end of our range," said Glenn Coleman, Chief Financial Officer. "Consistent with previous guidance, we expect first quarter organic growth to be in the low single-digits as we work through the sales channel integration in both of our segments, which we believe will result in higher organic growth in the second half of 2018."

In the future, the Company may record, or expects to record, certain additional revenues, gains, expenses or charges as described in the Discussion of Adjusted Financial Measures below that it will exclude in the calculation of organic revenue growth, adjusted EBITDA and adjusted EPS for historical periods and in providing adjusted EPS guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET today, Tuesday, February 27, 2018 to discuss fourth quarter and full-year 2017 financial results, and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.