On November 12, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that it is offering to sell $55 million of its common stock in an underwritten public offering (Press release, BioCryst Pharmaceuticals, NOV 12, 2019, https://biocryst.gcs-web.com/news-releases/news-release-details/biocryst-commences-public-offering-common-stock-0 [SID1234550961]). As part of this offering, BioCryst intends to grant the underwriters a 30-day option to purchase up to an additional $8.25 million of its common stock. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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J.P. Morgan is acting as sole book-running manager for the offering. JMP Securities and H.C. Wainwright & Co. are acting as lead managers for the offering.

All of the shares to be sold in the offering are being sold by BioCryst, with the proceeds to be used for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for the prophylactic BCX7353 program, primarily focusing on the U.S., EU and Japan; development of the BCX9930 program; development of the BCX9250 program; post-approval commitments for RAPIVABTM/ALPIVABTM; funding clinical development of pipeline assets; and capital expenditures and other general corporate expenses.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering is being made by means of a prospectus supplement and related prospectus. A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204.

On November 12, 2019 GO2 Foundation for Lung Cancer (a merger of the Bonnie J. Addario Lung Cancer Foundation and Lung Cancer Alliance) recognized AstraZeneca on November 9 at its 14th annual "Simply the Best" Dinner (Press release, GO2 Foundation, NOV 12, 2019, View Source [SID1234551020]). AstraZeneca was honored with the "Simply the Best Award" for its continued dedication to research and development of new lung cancer treatments.

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GO2 Foundation’s annual event is a celebration of survivors, hope and determination that brings together lung cancer patients and their families to recognize top minds in the lung cancer field. The gala was held at the Fairmont Hotel in San Francisco.

"Lung cancer treatment has evolved tremendously over the past decade with so many new options available to patients," said Chatrick Paul, head of US Oncology Business Unit, AstraZeneca. "We are thankful for the work that the GO2 Foundation for Lung Cancer is spearheading to accelerate collaboration across the oncology ecosystem and to ensure patients are able to navigate a difficult diagnosis. By educating and empowering patients to participate in making informed and thoughtful treatment choices based on comprehensive testing, patients can get the most effective treatments for their disease."

While the understanding of lung cancer continues to grow, so do the number of people diagnosed with the disease. Each year, nearly 225,000 Americans receive a lung cancer diagnosis and more than 160,000 will die of the disease. Eighty percent of those recently diagnosed never smoked, or quit more than a decade ago.

Go2 Foundation also recognized the following honorees at the Gala:

Dr. Roy Herbst, M.D., Ph.D., Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology; Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Associate Cancer Center Director for Translational Research, Yale Cancer Center will receive the Asclepios Award, which honors research pioneers in the fight to end lung cancer.
Jonathan Riess, M.D., M.S., Associate Professor at UC Davis Health System is the recipient of the A Breath Away from the Cure Award, which honors individuals for excellence in oncology, early detection and coordinated treatment.
Don Stranathan and Timothy Edward Gonsalves, survivors and each other’s caregivers, will be honored with the Wind Beneath My Wings Award, which celebrates the caring, compassionate people who go above the call of duty to care for a loved one facing lung cancer.
"When we held our first gala 14 years ago, our hopes of turning lung cancer into a chronic, manageable disease seemed like a far-distant dream," said Bonnie J. Addario, lung cancer survivor, co-founder and chair of GO2 Foundation. "But thanks to the many pioneers in research and discovery, we are moving closer and closer each day. It’s an exciting time for lung cancer research and we’re thankful to the many who support our efforts to advance research and patient care."

The Simply the Best Dinner and Gala is GO2 Foundation’s largest annual fundraising event. More information about the 14th annual Simply the Best Dinner and Gala is available here.

On November 12, 2019 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, reported financial results for the third quarter and nine months ended September 30, 2019, and provided a corporate update (Press release, Lipocine, NOV 12, 2019, View Source [SID1234551019]).

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Third Quarter and Recent Corporate Highlights

TLANDO, our oral testosterone replacement therapy ("TRT") product, received a Complete Response Letter ("CRL") from the United Stated Food and Drug Administration ("FDA") on November 8, 2019
First patient has been dosed in LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study of LPCN 1144 in confirmed pre-cirrhotic non-alcoholic steatohepatitis ("NASH") subjects.
The LiFT Phase 2 clinical study is a prospective, multi-center, randomized, double-blind, placebo-controlled multiple-arm study in biopsy-confirmed male NASH subjects with grade F2/F3 fibrosis and a NAFLD Activity Score ("NAS") ≥ 4 with a 36-week treatment period.
Top-line primary end point liver fat reduction data are currently expected in mid-2020, as measured by MRI-PDFF at 12 weeks, followed by 36-week biopsy data.
Data from a clinical trial of LPCN 1144 in non-alcoholic fatty liver disease ("NAFLD") were selected for presentation at The Liver Meeting 2019, held November 8th – 12th in Boston, MA.
Lipocine’s abstract was selected by the Scientific Program Committee of the American Association for the Study of Liver Disease ("AASLD") as a Poster of Distinction for presentation.
Four abstracts (two oral presentations and two poster presentation on TLANDO) were presented at the 20th Annual Fall Meeting of the Sexual Medicine Society of North America ("SMSNA"), October 24-27th in Nashville, TN.
The U.S. District Court of Delaware has set a trial date for Lipocine’s patent infringement lawsuit against Clarus’s JATENZO drug product relating to six of Lipocine’s U.S. patents.
Trial is set to begin August 24, 2020 at which time Lipocine plans to seek a permanent injunction for Clarus’s infringement.
"During the third quarter, we continued to advance our pipeline, with important milestones achieved," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "We are excited to continue enrolling subjects in the ongoing LPCN 1144 LiFT clinical study and look forward to participating in the TLANDO Post Action meeting with FDA to discuss a potential path forward for the approval of TLANDO while reserving our right to request for formal dispute resolution," said Dr. Mahesh Patel.

Third Quarter Ended September 30, 2019 Financial Results

Lipocine reported a net loss of $3.1 million, or ($0.12) per diluted share, for the quarter ended September 30, 2019, compared with a net loss of $2.5 million, or ($0.12) per diluted share, in the quarter ended September 30, 2018.

License revenue was $165,000 during the three months ended September 30, 2019 compared to no license revenue being recognized during the three months ended September 30, 2018. License revenue in 2019 relates to royalty payments received from Spriaso, LLC ("Spriaso") under a licensing agreement in the cough and cold field.

Research and development expenses were $1.7 million for the quarter ended September 30, 2019, compared with $1.4 million for the quarter ended September 30, 2018. The increase in research and development expenses was primarily due to increases in outside service costs related to the ramping up of the LPCN 1144 LiFT Phase 2 clinical study and increases in other research and development costs, offset by decreased contract research organization and outside consulting costs for TLANDO in connection with the completion of the ABPM study and filing of the NDA and a decrease in personnel costs. The decrease in personnel costs primarily relate to decreased stock compensation expense which resulted from the reversal of stock-based compensation expense recorded for the expected vesting of restricted stock units upon the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019). The decrease in stock-based compensation expense was offset by increased salaries and other personnel expenses.

General and administrative expenses were $1.4 million for the quarter ended September 30, 2019, compared with $0.9 million for the quarter ended September 30, 2018. The increase in general and administrative was primarily due to an increase in legal fees mainly due to the lawsuit filed against Clarus for patent infringement and increases in other general and administrative expenses, offset by a decrease in personnel costs attributable to the reversal of stock-based compensation expense recorded for the expected vesting of restricted stock units upon the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019).

As of September 30, 2019, the Company had unrestricted cash, cash equivalents and marketable securities aggregating $11.5 million, compared to $15.3 million at December 31, 2018. Additionally, as of September 30, 2019 and December 31, 2018 the Company had $5.0 million of restricted cash, which is required to be maintained as cash collateral under the Loan and Security Agreement with Silicon Valley Bank until TLANDO is approved by the FDA.

Nine Months Ended September 30, 2019 Financial Results

Lipocine reported a net loss of $9.7 million, or ($0.40) per diluted share, for the nine months ended September 30, 2019, compared with a net loss of $8.4 million, or ($0.40) per diluted share, in the nine months ended September 30, 2018.

License revenue was $165,000 during the nine months ended September 30, 2019 compared to license revenue of $428,000 during the three months ended September 30, 2018. License revenue in both 2019 and 2018 relates to royalty payments received from Spriaso under a licensing agreement in the cough and cold field.

Research and development expenses were $5.6 million for the nine months ended September 30, 2019, compared with $4.3 million for the nine months ended September 30, 2018. The increase in research and development expenses was primarily due to increases in the following costs: contract research organization and outside consulting costs for TLANDO in connection with completion of the ABPM study and the filing of the NDA, increased manufacturing costs for TLANDO, increased outside service costs related to the second quarter initiation of the LPCN 1144 LiFT Phase 2 clinical study, increased outside contract research organization costs related to TLANDO XR (LPCN 1111), increases in miscellaneous other research and development expenses and increased personnel costs. These cost increases were offset by a decrease in personnel costs attributable primarily to the reversal of stock-based compensation expense recorded for the expected vesting of restricted stock units upon the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019) and decreased contract manufacturing costs for LPCN 1107.

General and administrative expenses were $4.0 million for the quarter ended September 30, 2019, compared with $4.3 million for the quarter ended September 30, 2018. The decrease in general and administrative was primarily due to decreased personnel costs, including decreased salaries and benefits due to the elimination of our commercial sales and marketing team in 2018, a decrease in severance compensation, and a net decrease in stock-based compensation mainly due to reversal of stock-based compensation expense recorded for the expected vesting of restricted stock units upon the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019) and increases in other general and administrative expenses. These decreases in personnel costs and other general and administrative expenses were offset by increases in legal fees mainly due to the lawsuit filed against Clarus for patent infringement and increases in corporate insurance.

On November 12, 2019 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of best-in-class bioproduction tools for cell and gene therapies, reported financial results and operational highlights for the three and nine months ended September 30, 2019 (Press release, BioLife Science, NOV 12, 2019, View Source [SID1234551018]). The Company also revised 2019 financial guidance to reflect the acquisition of Custom Biogenic Systems, Inc. ("CBS") announced earlier today and introduced preliminary 2020 revenue guidance.

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Total revenue from sales of biopreservation media, automated thaw products and rental revenue of evo shipping containers for the third quarter of 2019 was $6.6 million, representing 25% year-over-year growth. Revenue from thaw product sales and evo rentals met or exceeded management’s internal plan for the quarter. Media sales were approximately $1 million below management’s internal plan primarily due to lower-than-expected orders from one large distributor and one cell therapy contract manufacturer. Order volume from these two customers has resumed to typical levels to date in the fourth quarter.

Mike Rice, BioLife Solutions CEO, remarked, "Q3 was another strong quarter of operational execution, growth and strategic activities supporting our vision to build BioLife into a premier bioproduction tools supplier. We achieved our financial goals in our cell and gene therapy franchise with the exception of biopreservation media revenue. Our media revenue remains concentrated with a relatively small number of large direct customers, distributors and CMOs and we anticipate some variability in demand from this segment.

"A primary driver of our M&A strategy is to broaden our product portfolio in order to mitigate the impact of this concentration, while pursuing our next financial milestone of $100 million in annual revenue. We believe that our acquisition of CBS will be a key component of our revenue growth and diversification strategy," he added. "With $1 to $2 million in revenue expected from CBS during the remainder of this year, we are raising the top of our 2019 revenue guidance range."

Third Quarter 2019 Revenue Highlights

Cell & Gene Therapy Market Segment

Gained 41 new cell and gene therapy customers.
Processed 18 new cross-reference requests for our FDA master files for CryoStor and HypoThermosol.
CryoStor and HypoThermosol are now estimated to be used in over 400 customer clinical applications.
Media and thaw product revenue was $3.4 million, representing 52% of total revenue with 19% growth over the prior-year period.
Announced the following customers have adopted the evo Cold Chain system for monitored shipments of cell and gene therapies: Adaptimmune, Autolus, Janssen, KBI Pharma, Mustang Bio, Nanjing Legend and Tessa Therapeutics.
Worldwide Distributor Network

Sales through our distributor network were $2.6 million, representing 40% of total revenue with 38% growth over the prior-year period.
Key worldwide distributors include STEMCELL Technologies, MilliporeSigma, Thermo Fisher, VWR, World Courier and QuickStat.
Third Quarter Operational Highlights

Completed the acquisition of SAVSU Technologies, Inc. ("SAVSU").
Formed cell and gene therapy bioproduction innovation co-investment accelerator program with Casdin Capital and announced initial strategic investments in iVexSol and Sexton Biotechnologies.
Successfully completed 19 audits of our quality system by cell and gene therapy direct customers and contract manufacturers.
Reached approximately 6 months of safety stock inventory of our critical media products in our Bothell and offsite warehouse to mitigate supply risk for cell and gene therapy customers.
Third Quarter and Nine Month 2019 Financial Results

BioLife Solutions is presenting various financial metrics under U.S. Generally Accepted Accounting Principles (GAAP) and as adjusted (non-GAAP). A reconciliation of GAAP to non-GAAP metrics appears at the end of this news release.

Revenue

Total revenue for the third quarter of 2019 increased 25% to $6.6 million compared with $5.3 million for the third quarter of 2018.
Sales of ThawSTAR automated thaw products totaled $324,000 for the third quarter.
Revenue from the rental of evo units and related accessory sales was $211,000 for the third quarter.
Total revenue for the nine months ended September 30, 2019 increased 34% to $19.1 million compared with $14.3 million for the first nine months of 2018.
Gross Margin

Gross margin (GAAP) for the third quarter of 2019 was 68.4% compared with 69.7% for the third quarter of 2018. Adjusted gross margin (non-GAAP) for the third quarter of 2019 was 69.2% compared with 69.7% in 2018.
Gross margin (GAAP) for the nine months ended September 30, 2019 was 70.2% compared with 68.5% for the same period in 2018. Adjusted gross margin (non-GAAP) for the nine months ended September 30, 2019 was 71.0% compared with 68.5% in 2018.
Operating Expenses

Operating expenses (GAAP) for the third quarter of 2019 were $5.1 million compared with $2.5 million for the third quarter of 2018. Adjusted operating expenses (non-GAAP) for the third quarter of 2019 were $4.5 million compared with $2.5 million in 2018.
Operating expenses (GAAP) for the nine months ended September 30, 2019 were $12.6 million compared with $7.2 million for the prior-year period. Adjusted operating expenses (non-GAAP) for the nine months ended September 30, 2019 were $11.6 million compared with $7.2 million in 2018.
Operating Income/(Loss)

Operating loss (GAAP) for the third quarter of 2019 was $597,000 compared with operating income of $1.2 million for the third quarter of 2018. Adjusted operating income (non-GAAP) for the third quarter of 2019 was $106,000 compared with $1.2 million in 2018.
Operating income (GAAP) for the nine months ended September 30, 2019 was $813,000 compared with $2.6 million for the same period in 2018. Adjusted operating income (non-GAAP) for the nine months ended September 30, 2019 was $2.0 million compared with $2.6 million in 2018.
Net Income Attributable to Common Stockholders

Net income attributable to common stockholders (GAAP) for the third quarter of 2019 was $9.3 million compared with $1.2 million for the third quarter of 2018. Included in net income for the third quarter of 2019 was a one-time gain of $10.1 million related to the purchase price accounting for the SAVSU acquisition. Adjusted net income attributable to common stockholders (non-GAAP) for the third quarter of 2019 was $215,000 compared with $1.2 million in 2018.
Net income attributable to common stockholders (GAAP) for the nine months ended September 30, 2019 was $10.6 million compared with $2.1 million for the same period in 2018. Included in net income for the first nine months of 2019 was a one-time gain of $10.1 million related to the purchase price accounting for the SAVSU acquisition. Adjusted net income attributable to common stockholders (non-GAAP) for the nine months ended September 30, 2019 was $2.4 million compared with $2.5 million in 2018.
Earnings per Share

Earnings per diluted share (GAAP) for the third quarter of 2019 were $0.37 compared with $0.05 for the third quarter of 2018. Included in earnings per share for the third quarter of 2019 was a one-time gain of $0.40 per share related to the purchase price accounting for the SAVSU acquisition. Adjusted earnings per diluted share (non-GAAP) for the third quarter of 2019 were $0.01 compared with $0.05 in 2018.
Earnings per diluted share (GAAP) for the nine months ended September 30, 2019 were $0.43 compared with $0.10 for the same period in 2018. Included in earnings per share for the nine months of 2019 was a one-time gain of $0.41 per share related to the purchase price accounting for the SAVSU acquisition. Adjusted earnings per diluted share (non-GAAP) for the nine months ended September 30, 2019 were $0.10 compared with $0.12 in 2018.
EBITDA

EBITDA, a non-GAAP measurement, for the third quarter of 2019 was $9.7 million compared with $1.2 million for the third quarter of 2018. Adjusted EBITDA for the third quarter of 2019 was $925,000 compared with $1.7 million in 2018.
EBITDA, a non-GAAP measurement, for the nine months ended September 30, 2019 was $11.0 million compared with $2.5 million for the prior-year period. Adjusted EBITDA for the nine months ended September 30, 2019 was $4.3 million compared with $4.0 million for the first nine months of 2018.
Roderick de Greef, BioLife Chief Financial Officer, remarked, "With the addition of CBS following the acquisitions of SAVSU and Astero earlier this year, along with expectation for continued growth in our cell and gene therapy franchise, our 2020 outlook is for revenue to increase by 69% to 90% compared with the midpoint of our revised 2019 revenue guidance."

2019 Financial Guidance

Management updated 2019 financial guidance to include contributions from Astero (beginning April 1), SAVSU (beginning August 8) and CBS (beginning November 12), as follows:

Total revenue is now expected to be $27.5 million to $31.5 million, representing growth of 39% to 60% over 2018; this compares with previous guidance for 2019 total revenue to be $27.5 million to $30.5 million. The acquisition of CBS is expected to contribute $1.0 million to $2.0 million in revenue for the remainder of 2019, offset by a reduction of $1.0 million in media revenue reflecting the order shortfall in the third quarter.
Gross margin is now expected to be 67% to 68%, compared with 69% in 2018; this compares with previous guidance for 2019 gross margin of 69% to 70%. Adjusted gross margin (non-GAAP) is now expected to be 68% to 69%, reflecting the impact of the SAVSU and CBS acquisitions.
Operating expenses are still expected to be $18.5 million to $19.5 million compared with $9.7 million in 2018. Adjusted operating expenses (non-GAAP) for 2019 are expected to be $16.5 to $17.5 million.
Affirmed expectation for full-year positive adjusted operating income, adjusted net income and adjusted EBITDA.
Preliminary 2020 Revenue Guidance

Based on the anticipated contributions from Astero, SAVSU and CBS, and continued growth in media revenue, management expects 2020 total revenue to be $50 million to $56 million, representing growth of 69% to 90% compared with the midpoint of 2019 revenue guidance.

Management will provide additional 2020 financial guidance during the 2019 fourth quarter and full year conference call, planned for March 2020.

Conference Call & Webcast

The Company will host a conference call and live webcast at 4:30 p.m. Eastern time today. To access the live webcast, please go to www.biolifesolutions.com/earnings/. Alternatively, you may access the live conference call by dialing (844) 825-0512 (U.S. & Canada) or (315) 625-6880 (International) with the following Conference ID: 7207519. A webcast replay will be available approximately two hours after the call and will be archived on www.biolifesolutions.com for 90 days.

On November 12, 2019 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the Stifel 2019 Healthcare Conference on Tuesday, Nov. 19, 2019 at 1:15 p.m. ET (6:15 p.m. GMT) from New York (Press release, Alkermes, NOV 12, 2019, View Source [SID1234551017]). In addition, Alkermes’ corporate presentation will be webcast live at the Jefferies London Healthcare Conference on Thursday, Nov. 21, 2019 at 4:00 p.m. GMT (11:00 a.m. ET) from London, U.K. These presentations may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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