On January 12, 2021 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX) ), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has entered into an agreement with a syndicate of Canadian underwriters (collectively, the "Underwriters"), pursuant to which the Underwriters have agreed to purchase, on a bought-deal basis, 14,546,000 units of the Company (the "Units") for aggregate gross proceeds to the Company of US$40,001,500 (equivalent to approximately C$51,081,915) (the "Offering") at a price of US$2.75 per Unit (equivalent to approximately C$3.51 per Unit) (Press release, Theratechnologies, JAN 12, 2021, View Source [SID1234573900]).

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Each Unit shall be comprised of one common share of the Company (each a "Common Share") and one-half of one Common Share purchase warrant of the Company (each whole warrant, a "Warrant"). Each Warrant shall entitle the holder thereof to purchase one Common Share at an exercise price of US$3.18 (equivalent to approximately C$4.06) at any time up to 36 months from the closing of the Offering.

The Company has granted to the Underwriters an option (the "Over-Allotment Option") to increase the size of the Offering by up to an additional number of Units, and/or the components thereof, that in aggregate would be equal to 15% of the total number of Units to be issued under the Offering, to cover over-allotments, if any, and for market stabilization purposes, exercisable at any time and from time to time up to 30 days following the closing of the Offering.

The net proceeds from the Offering will be used primarily to fund research and development activities, commercialisation initiatives, general and administrative expenses, working capital needs and other general corporate purposes.

The closing of the Offering is expected to occur on or about January 19, 2021 (the "Closing") and is subject to the Company receiving all necessary regulatory approvals, including the approval of the Toronto Stock Exchange (the "TSX") to list, on the date of Closing, the Common Shares and the Common Shares issuable upon exercise of the Warrants thereon. The Company agreed to use its commercial reasonable efforts to list the Warrants on the TSX on the date of Closing.

This press release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.

On January 12, 2021 AbbVie (NYSE: ABBV) reported that it will announce its fourth-quarter and full-year 2020 financial results on Wednesday, February 3, 2021, before the market opens (Press release, AbbVie, JAN 12, 2021, View Source [SID1234573899]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time. It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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On January 12, 2021 Inspyr Therapeutics, Inc. (OTC: NSPX), a pharmaceutical company focused on the research and development of novel targeted precision therapeutics for the treatment of cancer, reported the sale of $500,000 of a senior convertible debenture ("Debenture") from an existing institutional investor to pursue the research and development of the company’s novel portfolio of adenosine receptor antagonists and for general corporate purposes (Press release, Inspyr Therapeutics, JAN 12, 2021, View Source [SID1234573897]).

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The Debenture (i) is non-interest bearing, (ii) has a maturity date of January 12, 2022, (iii) is convertible into shares of common stock at the election of the Investor at any time, subject to beneficial ownership limitations and (iv) has a conversion price equal to the lesser of $0.33 and 85% of the lowest Volume Weighted Average Price (VWAP) during the five (5) Trading Days immediately prior to the conversion date, subject to adjustment, as further described in the Debenture.

The securities offered have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This current report shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state.

The company continues to execute on implementing its new corporate strategy by strengthening its portfolio and securing additional capital to pursue long-term strategic objectives and create value for stakeholders. Recently the company announced it strengthened its global intellectual property with the expansion of 18 additional issued patents in potential future commercial markets including the United States, Europe, the United Kingdom, Asia and other geographies. This newly issued intellectual property supports the research and development of RT-AR001, a potential first-in-class adenosine receptor modulator, and further business development initiatives.

The company is now in the process of commencing corporate operations including: pre-clinical research and development, manufacturing, regulatory and business development. The company is dedicated to continuing to execute its new corporate strategy and will provide timely updates to shareholders.

For a further description of the Debenture, please refer to the company’s Form 8-K filed on January 12, 2021.

On January 12, 2020 Boston Scientific Corporation (NYSE: BSX) reported net sales, based upon preliminary unaudited financial information, of approximately $2.71 billion during the fourth quarter of 2020 (Press release, Boston Scientific, JAN 12, 2021, View Source [SID1234573896]). This represents a decline of approximately (6.8) percent on a reported basis, approximately (8.3) percent on an operational1 basis and approximately (8.0) percent on an organic2 basis, all compared to the prior year period. Included within organic results is a negative 370 basis point impact associated with the conversion of U.S. WATCHMAN customers to a consignment inventory model and transition to the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device.

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For the full year 2020, the company generated net sales, based upon preliminary unaudited financial information, of approximately $9.91 billion. This represents a decline of approximately (7.7) percent on a reported basis, approximately (7.8) percent on an operational basis and approximately (11.3) percent on an organic basis, all compared to the prior year period. Included within organic results is a negative 170 basis point impact from WATCHMAN discussed above.

Fourth quarter preliminary financial results and recent developments:

Delivered the following fourth quarter sales growth/(declines) in each reportable segment3 compared to the prior year period:
MedSurg: 1.5 percent reported, 0.1 percent operational and 1.1 percent organic
Rhythm and Neuro: (6.1) percent reported, (7.7) percent operational and organic
Cardiovascular: (12.0) percent reported, (13.5) percent operational and organic

Accelerated sequential organic growth in the Peripheral Interventions business (4.8 percent organic growth), including 12 percent growth within the Interventional Medicine3 portfolio.

Returned to growth in the MedSurg reportable segment3 (1.1 percent organic growth) in the fourth quarter, driven by recovering procedural trends and favorable site of service mix. This includes a broad-based recovery in the Endoscopy business (1.5 percent organic growth), and growth within the stone and benign prostatic hyperplasia (BPH) franchises in Urology and Pelvic Health (0.6 percent organic growth).

WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device portfolio experienced strong customer demand in the fourth quarter. Organic sales declined 56 percent, which includes a negative 74 percent impact due to the conversion to a consignment inventory model and transition discussed above, and surpassed 150,000 cumulative implants worldwide.

Achieved key milestones for the Neuromodulation business with the WaveWriter Alpha portfolio of Spinal Cord Stimulator (SCS) systems including recent U.S. Food and Drug Administration (FDA) approval and third quarter 2020 launch in Europe.

1. Operational net sales growth rates exclude the impact of foreign currency fluctuations.

2. Organic net sales growth rates exclude the impact of foreign currency fluctuations and net sales from the recent acquisitions of Vertiflex, Inc. and BTG plc (BTG), each with no prior year comparable net sales. Organic net sales growth rates also exclude 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, as well as prior period net sales associated with our intrauterine health franchise, which we divested in Q2 2020.

3. 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 revenues from the date of acquisition.

4. 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. In Q4 2020, we signed a definitive agreement to sell Specialty Pharmaceuticals. The sale is expected to close in the first half of 2021, pending customary closing conditions.

J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021
Also as previously announced, Boston Scientific will participate in the virtual J.P. Morgan Healthcare Conference today. Mike Mahoney, chairman and chief executive officer, will present at approximately 8:20 a.m. EST. At 8:40 a.m. EST, Mike will be joined by Dan Brennan, executive vice president and chief financial officer, Dr. Ian Meredith, executive vice president and global chief medical officer, and Susie Lisa, vice president, Investor Relations, in a question-and-answer session with the host analyst and audience members.

A live webcast of the presentation and question-and-answer session will be available on the Investor Relations section of the Boston Scientific website at investors.bostonscientific.com. A replay of the webcast will be accessible at investors.bostonscientific.com beginning approximately one hour following the completion of the event.

Conference Call on Wednesday, February 3, 2021
As previously announced, Boston Scientific will webcast its conference call discussing financial results and business highlights for the fourth quarter and full year 2020 on Wednesday, February 3, 2021 at 8:00 a.m. EST. A live webcast of the conference call will be available on the Investor Relations section of the website at investors.bostonscientific.com. A replay of the webcast will be archived and available at investors.bostonscientific.com beginning approximately one hour following the completion of the meeting.

On January 12, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it will present updated overall survival (OS) data from the Phase III IMbrave150 study evaluating Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), compared with sorafenib, in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy (Press release, Hoffmann-La Roche, JAN 12, 2021, View Source [SID1234573895]).

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After a median follow-up of 15.6 months, an updated analysis showed that Tecentriq in combination with Avastin reduced the risk of death (OS) by 34%, with a median OS of 19.2 months, compared with 13.4 months for sorafenib (hazard ratio [HR]=0.66; 95% CI: 0.52–0.85). The updated OS, along with progression free survival (PFS) and objective response rate (ORR) results, were consistent with the primary analysis and support the use of the combination in HCC. Safety data for Tecentriq and Avastin were consistent with the known safety profiles of each individual drug, with no new safety signals identified.

"These results show that Tecentriq in combination with Avastin provides the longest survival that we’ve ever seen in a front-line Phase III study in unresectable HCC," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "The combination, which has now been approved in more than 60 countries around the world, represents a significant treatment advancement for patients with this challenging malignancy."

"After an additional year of follow-up, these data confirm the superiority of Tecentriq in combination with Avastin compared to sorafenib in patients with advanced HCC," said Dr Laura Kulik, Professor of Medicine, Interventional Radiology and Transplant, Feinberg School of Medicine, Northwestern University and member of the ASCO (Free ASCO Whitepaper) GI programme committee. "These results provide further confidence for physicians and patients in the use of this combination as first-line therapy."

These data will be presented in the Rapid Abstract Session: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer at the Gastrointestinal Cancers Symposium on Sunday 17 January at 15:30-16:15 ET.

Tecentriq in combination with Avastin is now approved around the world, including in the US, China, Japan and the EU, for people with unresectable HCC and is recommended in many clinical practice guidelines globally.

Roche is committed to tackling liver disease right across the disease journey, from the earliest stages through to advanced disease, with the ultimate goal of one day stopping chronic liver disease.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

Updated OS, PFS, response and duration of response data
Global results
Tecentriq + Avastin (n=336) Sorafenib (n=165)
Median OS (95% CI), mo 19.2
(17.0–23.7) 13.4
(11.4–16.9)
OS, HR
(95% CI), mo 0.66
(0.52–0.85)
Tecentriq + Avastin (n=336) Sorafenib (n=165)
Median PFS (95% CI), mo 6.9
(5.7–8.6) 4.3
(4.0–5.6)
PFS, HR
(95% CI), mo 0.65
(0.53–0.81)
Tecentriq + Avastin (n=326) Sorafenib (n=159)
Confirmed ORR (95% CI) (%) 30%
(25–35) 11%
(7–17)
CR, n (%) 25 (8%) 1 (< 1%)
PR, n (%) 72 (22%) 17 (11%)
SD, n (%) 144 (44%) 69 (43%)
Ongoing response, n (%) 54 (56%) 5 (28%)
Tecentriq + Avastin (n=97) Sorafenib (n=18)
Median DOR (95% CI), mo 18.1
(14.6, NE) 14.9
(4.9–17.0)
Overall survival results in the Chinese subpopulation
Tecentriq + Avastin (n=133) Sorafenib (n=61)
Median OS (95%CI), mo – Chinese subpopulation 24.0
(17.1, NE) 11.4
(6.7–16.1)
OS, HR
(95% CI), mo 0.53
(0.35–0.80)
PFS and all response data are reported by RECIST v1.1 assessed by an independent review facility.
Median follow-up: 15.6 months.
CR, complete response; DOR, duration of response; HR, hazard ratio; NE, not estimable; ORR, objective response rate; OS, overall survival; PFS, progression free response; PR, partial response; SD, stable disease.
See below for OS data from the primary analysis.

About the IMbrave150 study
IMbrave150 is a global Phase III, multicentre, open-label study of 501 people with unresectable HCC who had not received prior systemic therapy. People were randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until disease progression or unacceptable toxicity. The two primary endpoints were OS and independent review facility (IRF)-assessed PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Additional study endpoints included IRF-assessed overall response rate (ORR) per RECIST v1.1 and HCC mRECIST.

The primary analysis from the IMbrave150 study showed that after 8.6 months follow-up, Tecentriq in combination with Avastin reduced the risk of death (OS) by 42% (HR=0.58; 95% CI: 0.42–0.79; p=0.0006).

About hepatocellular carcinoma
HCC is an aggressive cancer with limited treatment options and is a major cause of cancer deaths worldwide.1 Every year, more than 815,000 people worldwide are diagnosed with HCC,1,2 with the majority of cases in Asia and almost half of all cases in China.2,3 In the US, the number of liver cancer cases have more than tripled since 1980 and HCC represents the fastest-rising cause of cancer-related death, while in Europe, liver cancer is also on the rise, accounting for more than 87,000 diagnoses and approximately 78,000 deaths in 2020.4-7 HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B or C) or alcohol consumption, and typically presents at an advanced stage.1 The prognosis for unresectable HCC remains poor, with few systemic therapeutic options and a 1-year survival rate of less than 50% following diagnosis.8

About the Tecentriq and Avastin combination
There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer, small cell lung cancer, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.