On November 5, 2020 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its third quarter 2020 results (Press release, Targovax, NOV 5, 2020, View Source [SID1234570034]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 CET today (details below).

RECENT HIGHLIGHTS
Announced that the ONCOS-102 and Imfinzi (durvalumab) trial successfully completed part 1 in colorectal cancer. The pre-defined disease control efficacy threshold in the colorectal cancer cohort was met and the part 2 has opened for recruitment of 14 additional patients.
Announced that an abstract on the mesothelioma trial has been accepted and will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, 9 -14 November 2020. The abstract presents the 12-month analysis of biomarkers and clinical outcome from the phase I/II trial in malignant pleural mesothelioma where ONCOS-102 is added to standard of care chemotherapy (pemetrexed / cisplatin). This analysis supports the data previously presented in June.
Completed a private placement, raising gross proceeds of approximately NOK 75 million (USD 8 million). The Private Placement attracted strong interest from existing shareholders and new institutional investors, both in the Nordics and internationally, and the transaction was oversubscribed multiple times.
Announced grant of European Patent no 3293201 by the European Patent Office. The patent covers the use of ONCOS-102 in combination with checkpoint inhibitors until 2036.
Formed a new Scientific Advisory Board (SAB), consisting of a group of world-renowned experts in immuno-oncology research and drug development carefully selected to act as advisors to guide the Targovax R&D strategy.
Øystein Soug, CEO commented:

"As the end of 2020 is approaching, we are entering a period of intensive data analysis and reporting from our ongoing ONCOS-102 clinical program. Important efficacy and immune marker readouts from our two Targovax-sponsored ONCOS-102 trials in mesothelioma and melanoma are due late in the year. In October we reported that the pre-defined threshold for clinical benefit was met in the colorectal cancer cohort of the ONCOS-102 and Imfinzi collaboration trial. The second part of this trial has now been opened for recruitment, and results are expected in about a year’s time. As we wrap up these phase I/II clinical trials, we are in parallel planning the next steps for ONCOS-102 development and expanding our pre-clinical pipeline to shape our future R&D programs."

Presentation
As a consequence of the Corona situation, there will not be a physical presentation of the results. Instead, we invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to ask questions during the presentation.

On November 5, 2020 Sysmex’s reported that financial forecast for the fiscal year ending March 31, 2021 was undetermined as of May 12, 2020, when the Company released its "Summary of Consolidated Financial Results for the Fiscal Year Ended March 31, 2020 (Press release, Sysmex, NOV 5, 2020, View Source [SID1234570033])." This forecast is now available, as outlined below.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

1. Forecast of Consolidated Financial Results for the Fiscal Year Ending March 31, 2021 (April 1, 2020 to March 31, 2021)
2. Reasons for Announcement

Previously, Sysmex’s financial forecast for the fiscal year ending March 31, 2021 was undetermined, as it was difficult to rationally calculate the impact the COVID-19 pandemic might have on the Company’s performance. However, we have now calculated and are disclosing our financial forecast, based on performance for the first six months of the fiscal year and taking into account the information and forecasts currently available.

In the first quarter, COVID-19 led to lower market demand for testing. As a result, performance in the first six months was down year on year, including net sales and all levels of profit. Nevertheless, testing demand began to recover in the second quarter (July through September) largely, and we expect operating performance to gradually rebound going forward.

For the fiscal year ending March 31, 2021, we expect net sales to increase year on year. Although the global outlook remains uncertain due to concerns about further waves of COVID-19 and ongoing trade friction between the United States and China, we expect sales to recover owing to solid resurgent testing demand and efforts to put healthcare systems in place. On the profit front, however, we expect year-on-year decreases in operating profit, Profit before tax and Profit attributable to owners of the parent as the result of decrease in reagent sales (stemming from lost testing demand in the first half) and proactive R&D expenses as we continuingly invest toward future growth.

These forecasts are calculated on the basis of currently available information. Actual results may differ for a variety of reasons.

The foreign exchange assumptions used for calculating financial forecasts from the third quarter onward are USD1.00 = JPY106, EUR1.00 = JPY122 and CNY1.00 = JPY15.3

On November 5, 2020 Boston Scientific Corporation (NYSE: BSX) reported that it will participate in two upcoming virtual investor conferences (Press release, Boston Scientific, NOV 5, 2020, View Source [SID1234570031]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On November 12, 2020, Meghan Scanlon, senior vice president and president, Urology and Pelvic Health, and Susie Lisa, vice president, Investor Relations, will participate in a 40-minute question-and-answer session with the host analyst at the 29th Annual Credit Suisse Virtual Healthcare Conference. The session will begin at approximately 8:00 a.m. EST.

On November 18, 2020, Dan Brennan, executive vice president and chief financial officer, and Susie Lisa will participate in a 30-minute question-and-answer session with the host analyst at the Stifel 2020 Virtual Healthcare Conference. The session will begin at approximately 8:40 a.m. EST.

A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.comView Source The replay will be available beginning approximately one hour following the completion of each event.

On November 5, 2020 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the third quarter ended September 30, 2020 (Press release, Vericel, NOV 5, 2020, View Source [SID1234570030]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Third Quarter 2020 Financial Highlights
•Total net revenues of $32.3 million, compared to $30.5 million in the third quarter of 2019;
•MACI net revenue of $24.4 million, Epicel net revenue of $6.7 million and NexoBrid revenue of $1.2 million related to the U.S. Biomedical Advanced Research and Development Authority (BARDA) procurement for national response preparedness;
•Gross margin of 70%, compared to gross margin of 69% in the third quarter of 2019;
•Net income of $3.6 million, or $0.08 per share, compared to $3.5 million, or $0.07 per share, in the third quarter of 2019;
•Non-GAAP adjusted EBITDA of $6.7 million, compared to $6.8 million in the third quarter of 2019;
•Operating cash flow of $4.6 million; and
•Cash and investments of $85.5 million as of September 30, 2020, compared to $79.0 million as of December 31, 2019, and no debt.

Business Highlights and Updates
•Reported record third quarter MACI revenue and total revenues, and the second highest quarterly Epicel revenue in history;
•Achieved double-digit growth in MACI revenue, implants and biopsies in the third quarter, including a record monthly high for biopsies in September;
•Announced the first delivery of NexoBrid to BARDA for emergency response preparedness; and
•Announced that the FDA accepted for review the Biologics License Application for NexoBrid for the treatment of severe thermal burns, with a PDUFA goal date of June 29, 2021.

1

"Our company executed exceedingly well during the third quarter as we generated stronger than expected financial results, drove strong commercial performance for MACI and Epicel, and achieved important milestones towards our goal of obtaining marketing approval of NexoBrid in the United States," said Nick Colangelo, President and CEO of Vericel. "Our third quarter results demonstrated the strength of our business across several measures and, while uncertainties related to COVID-19 remain, we are highly confident in the underlying fundamentals of our business and we remain on track to deliver strong revenue and profit growth in the years ahead."

Third Quarter 2020 Results
Total net revenues for the quarter ended September 30, 2020 increased 6% to $32.3 million, compared to $30.5 million in the third quarter of 2019. Total net product revenues for the quarter included $24.4 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $6.7 million of Epicel (cultured epidermal autografts) net revenue compared to $20.6 million of MACI net revenue and $9.9 million of Epicel net revenue, respectively, in the third quarter of 2019, and $1.2 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by BARDA for emergency response preparedness.

Gross profit for the quarter ended September 30, 2020 was $22.5 million, or 70% of net revenues, compared to $21.2 million, or 69% of net revenues, for the third quarter of 2019.

Total operating expenses for the quarter ended September 30, 2020 were $19.0 million, compared to $18.1 million for the same period in 2019. The increase was primarily driven by incremental employee expenses related to the MACI sales force expansion.

Vericel’s net income for the quarter ended September 30, 2020 was $3.6 million, or $0.08 per share, compared to $3.5 million, or $0.07 per share, for the third quarter of 2019.

Non-GAAP adjusted EBITDA was $6.7 million for the quarter ended September 30, 2020, compared to $6.8 million in the third quarter of 2019. A table reconciling non-GAAP measures is included in this press release for reference.

As of September 30, 2020, the company had $85.5 million in cash and investments, compared to $79.0 million as of December 31, 2019, and no debt.

Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software, if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s third-quarter 2020 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.

If you are unable to participate in the live call, the webcast will be available at View Source until November 5, 2021. A replay of the call will also b available until 11:00am (EDT) on November 12, 2020 by calling (855) 859-2056, or from outside the U.S. by calling (404) 537-3406. The conference ID is 5426489.

On November 5, 2020, Madrigal Pharmaceuticals, Inc. (the "Company") reported that it entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen"), pursuant to which the Company may issue and sell through Cowen, acting as agent, shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), from time to time having an aggregate sales price of up to $200,000,000 (the "ATM Offering") (Filing, 8-K, Synta Pharmaceuticals, NOV 5, 2020, View Source [SID1234570029]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sales of the Common Stock, if any, under the Sales Agreement will be made by any method that is deemed to be an "at the market" offering as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. The Company has no obligation to sell any of the Common Stock and may at any time suspend offers under the Sales Agreement or terminate the Sales Agreement pursuant to its terms.

Subject to the terms and conditions of the Sales Agreement, Cowen will use its commercially reasonable efforts to sell the shares of Common Stock from time to time, as the sales agent, based upon the Company’s instructions. The offering of shares of Common Stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Common Stock subject to the Sales Agreement or (ii) the termination of the Sales Agreement in accordance with its terms.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Sales Agreement, a copy of which is incorporated herein by reference as Exhibit 1.1.

The Common Stock to be sold under the Sales Agreement, if any, will be issued and sold pursuant to the Company’s automatic shelf registration statement on Form S-3 (File No. 333-225434), previously filed with the Securities and Exchange Commission ("SEC") on June 5, 2018. On November 5, 2020, the Company will file a prospectus supplement with the SEC in connection with the offer and sale of the Common Stock pursuant to the Sales Agreement. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock nor shall there be any sale of the Common Stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. The legal opinion of Hogan Lovells US LLP relating to the legality of the issuance and sale of the Common Stock pursuant to the ATM Offering is attached as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated by reference herein.