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Entry into a Material Definitive Agreement

On February 5, 2020, Adhera Therapeutics, Inc. (the "Company") reported that it has entered into a Securities Purchase Agreement with the investor parties thereto (collectively, the "Investors") pursuant to which the Investors agreed to purchase: (i) original issue discount unsecured Convertible Promissory Notes (the "Notes"), issued at a 10% original issue discount, for a total purchase price of $499,950, and (ii) warrants to purchase up to such number of shares of the common stock of the Company ("Common Stock") as is equal to the product obtained by multiplying 1.75 by the quotient obtained by dividing (A) the principal amount of the Notes by (B) the then applicable conversion price of the Notes (the "Warrants"; and the foregoing offering of securities being referred to as the "Offering") (Filing, 8-K, Adhera Therapeutics, FEB 5, 2020, View Source [SID1234554158]).

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The Company, which terminated its business operations and associated personnel in December 2019 as described in the Current Report on Form 8-K that the Company filed with the Securities and Exchange Commission on December 17, 2019, intends to use the proceeds of the Offering to continue its efforts to restructure the Company and to identify potential strategic transactions to enhance the value of the Company and its assets as such opportunities arise.

Pursuant to the Notes, the Company promises to pay the principal sum of the Notes to the respective Investor, or its permitted assigns (the "Holder"), on the date that is the six (6) month anniversary of the original issue date, or August 5, 2020 (the "Maturity Date"), or such earlier date as the Note is required or permitted to be repaid as provided thereunder, and to pay interest to the Holder on the aggregate unconverted and then outstanding principal amount of the Note in accordance with the provisions thereof. Interest shall accrue to the Holders on the aggregate unconverted and then outstanding principal amount of the Notes at the rate of 10% per annum, calculated on the basis of a 360-day year and shall accrue daily commencing on the original issue date until payment in full of the outstanding principal (or conversion to the extent applicable), together with all accrued and unpaid interest, liquidated damages and other amounts which may become due thereunder, has been made.

On or after May 5, 2020 until the Notes are no longer outstanding, the Notes shall be convertible, in whole or in part, at any time, and from time to time, into shares of Common Stock at the option of the noteholder. The conversion price shall be the lower of: (i) $0.50 per share of Common Stock and (ii) 70% of the volume weighted average price of the Common Stock on the trading market on which the Common Stock is then listed or quoted for trading for the prior ten (10) trading days (as adjusted for stock splits, stock combinations and similar events); provided, that if the Notes are not prepaid on or before May 5, 2020, then the conversion price shall be the lower of (x) 60% of the conversion price as calculated above or (y) $0.05 (as adjusted for stock splits, stock combinations and similar events). The conversion price of the Notes shall also be adjusted as a result of subsequent equity sales by the Company, with customary exceptions.

The exercise price of the Warrants shall be equal to the conversion price of the Notes, provided, that on the date that the Notes are no longer outstanding, the exercise price shall be fixed at the conversion price of the Notes on such date, with the exercise price of the Warrants thereafter (and the number of shares of Common Stock issuable upon the exercise thereof) being subject to adjustment as set forth in the Warrants.

Maxim Group LLC ("Maxim") served as placement agent in connection with the Offering. The Company intends to pay a placement fee to Maxim equal to 10% of the aggregate gross proceeds raised in the Offering.

UArizona Cancer Center Receives $6.9M Grant for Skin Cancer Prevention Study

On February 5, 2020 University of Arizona Cancer Center reported is developing new strategies to prevent and reduce the risk of squamous cell carcinoma, the second most-common form of non-melanoma skin cancer (Press release, University of Arizona, FEB 5, 2020, View Source [SID1234553939]).

Skin cancer is the most common malignancy worldwide, and one in three new cancers diagnosed is a form of skin cancer, according to the Skin Cancer Foundation. This amounts to about 5 million non-melanoma skin cancers in the United States each year.

Clara Curiel-Lewandrowski, M.D., director of the Cutaneous Oncology Program and co-director of the Skin Cancer Institute at the Cancer Center, is principal investigator for a five-year, $6.9 million grant from the National Cancer Institute (#P01CA229112), a unit of the National Institutes of Health.

"This award is both an endorsement of the scientific contributions made by the Skin Cancer Institute research team and a true opportunity to make new groundbreaking advances in skin cancer prevention and treatment," Curiel-Lewandrowski said. "This is a stamp of approval that says the University of Arizona Cancer Center is the place with quality and innovative approaches in skin cancer therapeutic prevention research nationwide."

The Program Project Grant will assess, in animal models and human studies, the importance of a novel immune protein known as TLR4, which is modulated by solar ultraviolet radiation. The second focus of the grant includes characterization of a cascade of messages within skin cells recently discovered by the team that are found to promote development of skin cancer after exposure to sunlight. An impactful aspect of the award relates to the formulation and testing of topical drugs – lotions and creams, for example – that effectively can inhibit the action of these proteins ultimately to prevent squamous cell carcinoma formation.

"We are one of the few institutions that has mastered both experimental and clinical studies that effectively mimic the effect of sunlight," Curiel-Lewandrowski said. "These models allow us to test drugs that can reproducibly and accurately stop or reverse the cellular damage caused by the sun through pilot and Phase 1 clinical trials.

"This highly integrated and translational research-based program project emphasizes the importance of a multidisciplinary and precision-medicine approach for the prevention of squamous cell carcinoma of the skin," Curiel-Lewandrowski continued. "These discoveries also can serve as a model to prevent other epithelial malignancies."

"Skin cancer is a great risk to many people, especially those of us in Arizona," said University of Arizona President Robert C. Robbins. "The talented, dedicated researchers at the Cancer Center understand the importance of identifying innovative approaches for skin cancer prevention and treatment, and it is a well-deserved honor for this team to receive this prestigious grant. It is important to discover the safest ways to ensure people significantly reduce their risk of skin cancer while enjoying all the sunshine that makes our beautiful state such a wonderful place to live."

The new funding is the latest award for Curiel-Lewandrowski and the Skin Cancer Institute team, which has been a leader in skin cancer research, treatment and prevention across Arizona and beyond.

"It is important that our community knows that our Skin Cancer Institute is here for them and that our aligned vision is to prevent and cure skin cancer through research, education and clinical care," Curiel-Lewandrowski said. "We have an exceptional team in place with a common mission: To eradicate skin cancer in Arizona by decreasing skin-cancer incidence, where late diagnosis is not an option, and no lives are lost due to this preventable disease."

Beam Therapeutics Announces Pricing of Initial Public Offering

On February 5, 2020 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported the pricing of its initial public offering of 10,588,236 shares of common stock at a public offering price of $17.00 per share (Press release, Beam Therapeutics, FEB 5, 2020, View Source [SID1234553921]). All of the shares are being offered by Beam Therapeutics. In addition, Beam Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,588,235 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. Beam Therapeutics’ common stock is expected to begin trading on The Nasdaq Global Select Market on February 6, 2020 under the ticker symbol "BEAM."

The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Beam Therapeutics, are expected to be approximately $180 million excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on February 10, 2020, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Jefferies and Barclays are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

A registration statement relating to the shares being sold in this offering became effective by the Securities and Exchange Commission on February 5, 2020. The offering is being made only by means of a prospectus, copies of which may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected]; Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at 877-821-7388 or by email at [email protected]; or Barclays Capital Inc., Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-888-603-5847, or email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Tumor secreted ANGPTL2 facilitates recruitment of neutrophils to the lung to promote lung pre-metastatic niche formation and targeting ANGPTL2 signaling affects metastatic disease

On February 5, 2020 Oncotarget reported that tumor-derived ANGPTL2 stimulates lung epithelial cells, which is essential for primary tumor-induced neutrophil recruitment in lung and subsequent pre-metastatic niche formation (Press release, Oncotarget, FEB 5, 2020, View Source [SID1234553905]).

Lastly, they identified that a p63 isoform, Np63, drives a high level of ANGPTL2 secretion and pharmaceutical inhibition of ANGPTL2 signaling by a non-RGD-based integrin-binding peptide diminished metastatic load in lungs likely due to reduction of the lung pre-metastatic niche formation.

Dr. Hakan Cam from the Center for Childhood Cancer and Blood Diseases at Nationwide Children’s Hospital as well as the Department of Pediatrics at The Ohio State University in Columbus Ohio USA said in their Oncotarget paper, "Primary tumors selectively and actively modify potential sites of metastasis, even prior to dissemination"

For instance, neutrophils have been identified as facilitators of breast cancer metastasis and of lung cancer metastasis after UV-induced inflammation through tumor-secreted exosomal RNAs.

Here, the scientists set out to determine how tumor-derived factors might affect the activation of lung epithelial cells in ways that elicit pro-metastatic inflammatory responses and facilitate the formation of the pre-metastatic following the recruitment of neutrophils.

It is also well established that the induction of inflammation-related genes results in the activation of neutrophils and as described above a body of evidence suggesting that the recruitment of neutrophils promotes cancer metastasis.

Collectively, by using spontaneous metastatic models, they investigated whether tumor secreted ANGPTL2 induces inflammation on lung epithelial cells by activating alpha5beta1 receptor and recruiting neutrophils to the pre-metastatic niche.

The Cam Research Team concluded in their Oncotarget article that they investigated whether lung epithelial cells might be essential for primary tumor-induced neutrophil recruitment to lung and the role that these infiltrating cells play in osteosarcoma PMN formation using spontaneous metastatic models.

Boston Scientific Announces Results For Fourth Quarter And Full Year 2019

On February 5, 2020 Boston Scientific Corporation (NYSE: BSX) reported sales of $2.905 billion during the fourth quarter of 2019 (Press release, Boston Scientific, FEB 5, 2020, View Source [SID1234553904]). This represents growth of 13.4 percent on a reported basis, 14.1 percent on an operational1 basis and 7.3 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP earnings of $3.996 billion or $2.83 per share (EPS), compared to GAAP earnings of $386 million or $0.27 per share a year ago and achieved adjusted earnings per share of $0.46 for the period, compared to $0.39 a year ago. Reported GAAP earnings include a significant net income tax benefit explained in the Use of Non-GAAP Financial Measures section below.

For the full year 2019, the company generated sales of $10.735 billion. This represents growth of 9.3 percent on a reported basis, 11.1 percent on an operational1 basis and 7.3 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP earnings of $3.33 per share, inclusive of the net income tax benefit mentioned above, compared to $1.19 in 2018 and delivered full year adjusted earnings per share of $1.58, compared to $1.47 in 2018. Full year 2018 GAAP and adjusted earnings per share included a $0.07 net tax benefit.3

"We delivered strong revenue and adjusted EPS growth for the quarter and the year by developing innovative products, executing on our category leadership strategy and mitigating challenges," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We’re confident that we have the pipeline, leadership team and focused execution to deliver on our goals to address unmet clinical needs and work to improve the lives of millions of patients."

Fourth quarter financial results and recent developments:

Reported fourth quarter sales of $2.905 billion, representing an increase of 13.4 percent on a reported basis, compared to the company’s guidance range of 13 to 15 percent; 14.1 percent on an operational basis; and 7.3 percent on an organic basis, compared to the company’s guidance range of 8 to 9 percent, all compared to the prior year period.
Reported fourth quarter GAAP earnings of $2.83 per share, compared to the company’s guidance range of $0.22 to $0.25 per share. Reported GAAP earnings include net litigation charges of $169 million, or $0.12 per share, primarily related to the previously disclosed Channel Medsystems, Inc. matter, and a net income tax benefit of $4.102 billion, or $2.90 per share, explained in the Use of Non-GAAP Financial Measures section below. Achieved adjusted earnings per share of $0.46 per share, compared to the guidance range of $0.42 to $0.45 per share.
Achieved fourth quarter revenue growth in all segments5, compared to the prior year period:
MedSurg: 9.8 percent reported, 10.6 percent operational and organic
Rhythm and Neuro: 3.5 percent reported, 4.1 percent operational and 1.0 percent organic
Cardiovascular: 18.7 percent reported, 19.3 percent operational and 10.0 percent organic
Delivered fourth quarter Medical Device5 revenue growth in all regions, compared to the prior year period:
U.S.: 13.4 percent reported and operational
EMEA (Europe, Middle East and Africa): 7.2 percent reported and 9.7 percent operational
APAC (Asia-Pacific): 11.3 percent reported and 11.5 percent operational
Emerging Markets4: 14.1 percent reported and 16.2 percent operational
Received U.S. Food and Drug Administration (FDA) 510(k) clearance and Breakthrough Device Designation, and CE Mark for the EXALT Model D Duodenoscope, the first and only single-use duodenoscope. Initiated limited market release, including a successful first case in patient undergoing endoscopic retrograde cholangiopancreatography (ERCP), a procedure performed more than 1.5 million times worldwide each year to diagnose and treat pancreatic and biliary conditions.
Positive 12-month data from the investigator-sponsored COMPARE trial, demonstrating non-inferiority of the low-dose paclitaxel-coated Ranger Drug-Coated Balloon (DCB) (2.0 µg/mm2) compared to the higher dose IN.PACT DCB (Medtronic) balloon (3.5 µg/mm2), was presented at the Leipzig Interventional Course (LINC) Congress. COMPARE is the first randomized controlled head-to-head trial comparing two drug-coated balloon technologies.
Presented at the 2020 Gastrointestinal Cancers Symposium positive data on the impact of personalized radiation dosing using TheraSphere Yttrium-90 Glass Microspheres from the investigator-sponsored DOSISPHERE-01 trial. Data demonstrated personalized dosing of radiation increased overall survival of patients with the most common type of liver cancer, when compared to patients who received a standardized dose.
Announced plans to initiate CHAMPION-AF–a randomized head-to-head trial of the WATCHMAN FLX Left Atrial Appendage Closure Device vs. direct oral anticoagulants–in the second half of 2020. The global trial is designed to study stroke risk reduction efficacy and bleeding endpoints in lower-risk patients with non-valvular atrial fibrillation.
Received Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval and positive reimbursement in Japan for the LOTUS Edge Aortic Valve System, a minimally invasive transcatheter aortic valve replacement (TAVR) technology for patients with severe aortic stenosis.
Received FDA approval for the INGEVITY+ active fixation pacing lead for use with pacemakers and defibrillators. Built on the INGEVITY platform with proven longevity, the new lead is designed to offer a more predictable implant experience for physicians.
Received CE Mark for the POLARx Cryoablation System, which is indicated for the treatment of patients with paroxysmal atrial fibrillation (AF), an intermittent form of AF which causes an irregular and often abnormally fast heart rate.
Announced at the North American Neuromodulation Society (NANS) Annual Meeting results of the COMBO randomized clinical trial showing that Combination Therapy delivered by the Spectra WaveWriter Spinal Cord Stimulator (SCS) System achieved an 88% responder rate in treating chronic pain–much higher than monotherapy alone. Also at NANS, announced an exclusive partnership with IBM Research to develop AI-generated predictive algorithms for highly personalized chronic pain therapy.
Completed a public offering of €900 million aggregate principal amount of 0.625% Senior Notes due 2027, and completed cash tender offer for approximately $1.0 billion aggregate principal amount of certain outstanding senior notes.
Completed the sale of BTG’s royalty revenue stream associated with Zytiga for $256 million in cash, the proceeds from which were used to repay portions of outstanding debt.
1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic revenue growth excludes the impact of foreign currency fluctuations and sales from the recent acquisitions of NxThera, Inc., Claret Medical, Inc., Augmenix, Inc., Vertiflex, Inc. and BTG plc (BTG), each with no prior year comparable sales. Organic revenue growth also excludes the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction.

3. The full year 2018 net tax benefit of $0.07 includes our previously disclosed second quarter $0.06 benefit from settling the IRS Stipulation of Settled Issues for the 2001 through 2010 tax years, offset by a fourth quarter $0.05 charge for our previously announced tax reinvestment strategy. In addition, the net benefit includes a $0.06 benefit in the fourth quarter for the settlement with the IRS of our 2011 through 2013 tax years.

4. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities in our Medical Devices business. Periodically, we assess our list of Emerging Markets; effective January 1, 2019, we updated our list of Emerging Market countries. We have revised prior year amounts to the current year’s presentation. The revision had an immaterial impact on prior year Emerging Markets sales.

5. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s 2019 revenues from the date of acquisition.

6. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals.

Net sales for the fourth quarter by business and region:

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of recent aforementioned acquisitions / divestitures are not prepared in accordance with U.S. GAAP.

Net sales for the full year by business and region:

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of recent aforementioned acquisitions / divestitures are not prepared in accordance with U.S. GAAP.

Guidance for Full Year and First Quarter 2020

The company estimates revenue growth for the full year 2020, versus the prior year period, to be in a range of approximately 10 to 12 percent on a reported basis and a growth range of approximately 6.5 to 8.5 percent on an organic basis. Full year organic guidance excludes the impact of foreign currency fluctuations and contribution of approximately 350 basis points from the acquisitions of Vertiflex and BTG, each with less than a full year of related net sales in the prior period, as well as the impact of the divestiture of our global embolic microspheres portfolio as part of the acquisition of BTG. The company estimates income on a GAAP basis in a range of $0.95 to $1.00 per share and estimates adjusted earnings, excluding certain charges (credits) in a range of $1.74 to $1.79 per share.

The company estimates revenue growth for the first quarter of 2020, versus the prior year period, to be in a range of approximately 10 to 12 percent on a reported basis and a growth range of approximately 5 to 7 percent on an organic basis. First quarter sales guidance contemplates a preliminary negative sales impact estimate of $10 million to $40 million due to the potential effect of the coronavirus on procedure volumes in China and supply chain disruption. First quarter organic guidance excludes the impact of foreign currency fluctuations and contribution of approximately 600 basis points from the acquisitions of Vertiflex and BTG, each with no prior year comparable sales, as well as the impact of the divestiture of our global embolic microspheres portfolio as part of the acquisition of BTG. The company estimates earnings on a GAAP basis in a range of $0.16 to $0.19 per share and estimates adjusted earnings, excluding certain charges (credits) in a range of $0.37 to $0.40 per share.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.