On January 30, 2020 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio" or the "Company") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, reported that it has priced its initial public offering of 1,333,360 American depositary shares ("ADSs") at US$12.00 per ADS for a total offering size of approximately US$16.0 million, assuming the underwriters do not exercise their over-allotment option to purchase additional ADSs (Press release, Anpac Bio, JAN 30, 2020, View Source [SID1234553720]). Each ADS represents one Class A ordinary share of the Company. The ADSs are expected to begin trading on the Nasdaq Global Market on January 30, 2020 under the ticker symbol "ANPC."

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The Company has granted the underwriters an option, exercisable within 30 days from the date of the final prospectus, to purchase up to an aggregate of 200,004 additional ADSs at the initial public offering price, less underwriting discounts and commissions, to cover over-allotments.

WestPark Capital, Inc. and Univest Securities, LLC are acting as joint bookrunners of this offering and as the representatives of the underwriters.

AnPac Bio’s registration statement relating to the offering has been filed with, and declared effective by, the United States Securities and Exchange Commission. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of, these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 30, 2020 Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, reported financial results for the quarter ended December 31, 2019 (Press release, Edwards Lifesciences, JAN 30, 2020, View Source [SID1234553719]).

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Fourth Quarter Results and Outlook

Q4 sales grew 20% to $1.2 billion; underlying1 sales grew 19%
Q4 TAVR sales grew 29%; underlying sales grew 30%
Q4 EPS was $1.32; adjusted1 EPS grew 25% to $1.46
Full year 2019 sales and earnings significantly exceeded original guidance
2020 guidance ranges increased: sales $4.6 billion to $5.0 billion; EPS $6.15 to $6.40
SAPIEN 3 transcatheter heart valve received low risk indication expansion in Europe
EVOQUE tricuspid early feasibility study receives FDA approval
"We are pleased to report robust fourth quarter performance that delivered 19 percent sales growth on an underlying basis, driven by our portfolio of innovative technologies. For the full year 2019, we reported 15 percent revenue growth on an underlying basis, with double-digit growth in each region," said Michael A. Mussallem, chairman and CEO. "Most importantly, I’m proud to report we’re poised to help even more patients benefit from Edwards’ life-saving technologies. We invested aggressively in transformative therapies in 2019 and this will continue in 2020 as our commitment has never been greater."

2019 Full Year Results

Sales for the year ended December 31, 2019 were $4.3 billion, up 17 percent over the prior year, or 15 percent on an underlying basis. Diluted earnings per share for 2019 were $4.93, while adjusted earnings per share grew 19 percent, to $5.57.

Transcatheter Aortic Valve Replacement (TAVR)

The company reported fourth quarter global TAVR sales of $763 million, a year-over-year increase of approximately 30 percent on both a reported and underlying basis with impressive strength in the U.S. Global average selling prices remained stable.

In the fourth quarter, the company estimates U.S. TAVR procedures grew approximately 40 percent on a year-over-year basis and Edwards’ growth was comparable. Outside the U.S., the company estimates that total TAVR procedures grew in the high-teens on a year-over-year basis and Edwards’ growth was comparable. As previously reported, Edwards became the first company to receive CE Mark for TAVR in Europe for the treatment of patients diagnosed with severe aortic stenosis who are at low risk for open-heart surgery.

Transcatheter Mitral and Tricuspid Therapies (TMTT)

TMTT is on track to achieve the milestones discussed at the company’s recent Investor Conference, including executing four pivotal studies. In addition, the company announced that the EVOQUE tricuspid replacement valve system has recently received U.S. Food and Drug Administration (FDA) approval for an Early Feasibility Study and a "breakthrough device" designation, a program intended to help patients receive more timely access to designated medical technologies.

Full year 2019 TMTT sales of $28 million came in below the original guidance of approximately $40 million as the company continued to execute a disciplined introduction and premium pricing strategy of the PASCAL system, which moderated European site activation. Fourth quarter sales of $7 million were negatively impacted by the voluntary PASCAL system field corrective action completed in the quarter. PASCAL clinical outcomes continue to be favorable and physician feedback remains positive. As the PASCAL system roll-out expands, the company will remain focused on procedural success and differentiated patient outcomes.

Surgical Structural Heart and Critical Care

Surgical Structural Heart sales for the quarter were $205 million, down one percent compared to the fourth quarter of 2018, and down three percent on an underlying basis. The sales decline was the result of lower surgical aortic valve procedures in the U.S. as TAVR adoption increased, partially offset by continued strong adoption of the company’s premium high-value technologies.

Critical Care sales were $199 million for the quarter, representing an increase of 12 percent versus the fourth quarter of 2018 or eight percent on an underlying basis. This performance was driven by strong demand for the HemoSphere advance monitoring platform and continued adoption of Smart Recovery. Growth in the quarter was led by sales in the U.S.

Additional Financial Results

For the quarter, the company’s adjusted gross profit margin was 75.8 percent, compared to 76.1 percent in the same period last year. This reduction was driven by spending in support of the new European medical device regulations and one-time costs associated with migrating Cardioband production from Israel to Ireland, partially offset by the benefit of a more profitable product mix.

Selling, general and administrative expenses increased 21 percent to $347 million for the quarter, driven by increased field clinical personnel to support TAVR cases in the U.S. and TMTT cases in Europe, as well as accelerated actions related to disease awareness and therapy adoption.

Research and development for the fourth quarter increased 19 percent to $194 million, or 16.5 percent of sales. This increase was primarily the result of continued investments in the company’s transcatheter structural heart programs, including spending on clinical trials.

Free cash flow for the fourth quarter was $328 million, defined as cash flow from operating activities of $399 million, less capital spending of $71 million.

Cash, cash equivalents and short-term investments totaled $1.5 billion at December 31, 2019. Total debt was $594 million.

Outlook

Overall, 2020 sales guidance for Edwards is now expected to be $4.6 to $5.0 billion versus the company’s previous range of $4.5 to $5.0 billion. Additionally, the company now expects full year 2020 adjusted earnings per share of $6.15 to $6.40 versus previous guidance of $6.05 to $6.30.

For the first quarter of 2020, the company projects total sales to be between $1.15 and $1.2 billion, and adjusted EPS of $1.49 to $1.59.

"We were very proud of the significant progress we made in advancing transformational therapies in 2019, as well as our strong financial performance. We are enthusiastic about the future of transcatheter-based technologies, and the promise of treating the many structural heart patients still in need, which positions us very well for 2020 and beyond. We firmly believe our patient-focused innovation strategy can transform care and bring value to patients, healthcare systems, and shareholders," said Mussallem.

On January 30, 2020 MedX Health Corp. ("MedX" or the "Company") (TSX-V:MDX) is reported that it has received Conditional Approval from the TSX Venture Exchange for a non-brokered Private Placement to accredited investors of up to 25,000,000 units at $0.12 per unit ("Unit"), to raise up to $3,000,000 (Press release, MedX Health, JAN 30, 2020, View Source [SID1234553718]). Each Unit will be comprised of One (1) fully paid common share and One (1) Share Purchase Warrant, exercisable to purchase One (1) further Common Share at the price of $0.20, exercisable for a period of two years from the date of issue. Closing of the Placement, which will take place in tranches, will be subject to receipt of subscriptions and a number of other conditions, including without limitation the receipt of all relevant regulatory and Stock Exchange approvals or acceptances. Qualified Agents may receive commissions in respect of subscriptions introduced by them by way of cash equal to 8% of funds so introduced, and issuance of agent’s warrants ("Agent’s Warrant(s)") equal in number to 8% of the number of units so subscribed for. Each Agent’s Warrant, which is non-transferable, will be exercisable to acquire one Unit at $0.12 per Unit, at any time during the period of two years following the Closing.

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The Company further announces that on January 30, 2020, it closed a first tranche of the Private Placement by issuing a total of 1,485,000 Units, to raise $178,200 from accredited investors. The securities issued on January 30, 2020, will be restricted from trading for four months. In connection with this first Closing, a cash commission of $10,080 was paid and 84,000 Agent’s Warrants were issued. Following this first Closing, the Private Placement offering remains open for further subscriptions, subject to all relevant regulatory and other consents and approvals, including acceptance by the TSX Venture Exchange.

On January 30, 2020 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, February 14, 2020 to discuss its 2019 operating results (Press release, ImmunoGen, JAN 30, 2020, View Source [SID1234553717]). Management will also provide a brief update on the business.

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Conference Call Information
To access the live call by phone, dial (877) 621-5803; the conference ID is 3989656. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location.

On January 30, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Duke University investigators have dosed the first patient in a proof-of-concept Phase 1b study to evaluate GlycoMimetics’ novel GMI-1359 drug candidate in patients with advanced breast cancer (Press release, GlycoMimetics, JAN 30, 2020, View Source [SID1234553716]). The dose-escalating study will enroll up to 12 individuals with metastatic, hormone receptor positive breast cancer with stable or minimally progressive disease, including bone metastasis. GMI-1359 is a dual inhibitor of both E-selectin and CXCR4. The trial is designed to evaluate safety, pharmacokinetics and pharmacodynamic measures of biologic activity, such as increases in circulating tumor cells and mobilization of CD34+ and immune T-cell subsets. GlycoMimetics expects the trial results to be available in late 2020, the conclusions of which the Company will use to inform future development of GMI-1359.

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Kelly Marcom, M.D., and Dorothy Sipkins, M.D., Ph.D., both of the Duke Cancer Institute, are the trial’s co-principal investigators. This clinical trial builds on published findings from Dr. Sipkins on the key roles of both E-selectin and CXCR4 in the trafficking of metastatic cancer cells and of their establishment as micro-metastases in bone. Dr. Sipkins’ research suggests that both E-selectin and CXCR4 mediate key mechanisms that promote progression and migration of cancer cells to protective niches in the bone marrow micro-environment, and reveals the potential for an E-selectin and CXCR4 inhibitor like GMI-1359 to molecularly excise disseminated breast cancer cells.1

"The initiation of enrollment is an important milestone in our exploration of GMI-1359 and its potential as a novel approach to treating metastatic cancer," said GlycoMimetics Senior Vice President of Clinical Development and Chief Medical Officer Helen Thackray, M.D., FAAP. "We’re pleased to have such distinguished researchers at Duke University begin to explore the use of this investigational therapy and look forward to learning more about its potential impact as clinical study advances."

More information on this clinical trial can be found at www.clinicaltrials.gov.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as acute myeloid leukemia and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The newly initiated Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity.