On July 20, 2021 Zealand Pharma A/S ("Zealand") reported that initiated a share repurchase program to acquire Danish common stock for incentive programs in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (Press release, Zealand Pharmaceuticals, JUL 20, 2021, View Source [SID1234585020]).

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Zealand has entered an arrangement with Danske Bank A/S to act as exclusive manager under the program. Danske Bank A/S will buy back shares on behalf of Zealand and make related trading decisions independently of and without influence by Zealand.

Under the program, Danske Bank A/S will buy back shares on behalf of Zealand for an amount up to DKK 32,070,896. The share repurchase program is expected to be completed no later than July 29, 2021 and comprises up to 154,187 shares.

Since the announcement dated 6 July 2021, the following transactions have been made:

The details for each transaction made under the share repurchase program are included as an appendix to this announcement.

With the transactions stated above, Zealand owns a total of 198,288 shares with a nominal value of DKK 1 each as treasury shares, corresponding to 0.46% of the total share capital. The total share capital of the company is DKK 43,541,838 with a nominal value of DKK 1 each.

On July 21, 2021 Ascletis Pharma Inc. (HKEX code: 1672) reported that China National Medical Products Administration (NMPA) has approved the Phase III clinical trial application of ASC40 combined with Bevacizumab for treatment of patients with recurrent glioblastoma (rGBM) (Press release, Ascletis, JUL 21, 2021, View Source [SID1234585037]).

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The Phase III registrational study is a randomized, double-blind, placebo-controlled, multi-center clinical trial in China to evaluate progression-free survival (PFS), overall survival (OS) and safety of patients with rGBM. Approximately 180 patients will be 1:1 randomized to Cohort 1 (oral ASC40 tablet QD + Bevacizumab) and Cohort 2 (matching placebo tablet QD + Bevacizumab).

On May 25, 2021, the Company announced that the clinical trial application for rGBM was accepted for review by China NMPA (Details referring to press release: View Source).

Based on published data, in China, glioblastoma (GBM) represents 46.1% of gliomas and has an incidence rate of approximately 2.85 to 4.56 per 100,000 population per year, suggesting approximately 40,000 to 64,000 new cases of GBM per year. More than 90% GBM patients will relapse after surgery, radiation and chemotherapies. In the United States, GBM represents 56.6% of gliomas and has an incidence rate of approximately 3.21 per 100,000 population per year.

Bevacizumab is the only drug which has been approved for rGMB indication in China as of September, 2020. The data of BELOB Trial indicated that median PFS was three months for patients with rGBM after Bevacizumab treatment.

Lipid metabolism has been reported to play a critical role in various cancers. Fatty acid synthase (FASN) is one of the most important proteins which regulate lipid metabolism. Many solid and hematopoietic tumors overexpress FASN, including rGBM, non-small cell lung, breast, ovarian, prostate, colon, pancreatic cancers, and non-Hodgkin lymphoma.

ASC40 (known as TVB-2640 outside China) is a potent, selective and safe oral small molecule inhibitor of FASN. The data from the Phase II trial have shown that the overall response rate (ORR) for ASC40 (TVB-2640) plus Bevacizumab was 65% including a complete response (CR) of 20% and a partial response (PR) of 45%. Furthermore, the Phase II data indicate that the progression-free survival at six months (PFS6) observed for ASC40 (TVB-2640) plus Bevacizumab was 47%, representing a statistically significant improvement in PFS6 over the historical Bevacizumab monotherapy PFS6 of 16% (BELOB Trial) (P=0.01). ASC40 (TVB-2640) in combination with Bevacizumab was safe and well tolerated in such patient population (ClinicalTrials.gov Identifier: NCT03032484).

"I am thrilled to be the principal investigator leading the ASC40 Phase III trial for rGBM," said Dr. Wenbin Li, Vice Chairman and Secretary General of Glioma Committee of Chinese Cancer Association, Director of the Comprehensive Tumor Treatment Center, Beijing Tiantan Hospital, Capital Medical University, "Based on strong Phase II data, I hope and expect that targeting tumor lipid metabolism with ASC40 will offer a promising therapeutic approach to treat rGBM which is one of the most devastating cancers."

"ASC40 Phase III clinical trial approval by NMPA is a significant milestone for our oncology pipeline since the Company announced, in March this year, an investment escalation in R&D of cancer lipid metabolism and oral checkpoint inhibitors." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "With the strong momentum from the ASC40 Phase III approval, our talented R&D team is accelerating the clinical development programs of ASC40 for other oncology indications as well as oral PD-L1 small molecule inhibitor programs."

A Phase I clinical trial was completed on 136 patients with advanced tumor from the United States and United Kingdom. The patients were treated with ASC40 (TVB-2640) alone and with a taxane. The data from this Phase I trial have demonstrated FASN target engagement, good safety, pharmacokinetics as well as promising responses of ASC40 (TVB-2640) in patients with advanced solid tumors, particularly in lung cancer with KRAS mutations, ovarian cancer, and breast cancer (ClinicalTrials.gov Identifier: NCT02223247).

There are additional clinical trials of ASC40 (TVB-2640) ongoing in the United States in patients with KRAS mutation non-small cell lung cancer (ClinicalTrials.gov Identifier: NCT03808558) and breast cancer (ClinicalTrials.gov Identifier

On July 20, 2021 IMV Inc. ("IMV" or the "Corporation") (NASDAQ: IMV; TSX: IMV), a clinical-stage immuno-oncology corporation, reported the closing of its previously-announced underwritten public offering (the "Offering") of 14,285,714 units (the "Units") at a price to the public of US$1.75 per Unit, for aggregate gross proceeds to the Corporation of approximately US$25 million, before deducting underwriting commissions and Offering expenses and excluding any proceeds the Corporation may receive from the exercise of the underlying warrants (Press release, IMV, JUL 20, 2021, View Source [SID1234584971]). Each Unit is comprised of one common share and three-quarters of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant entitles the holder thereof to purchase one common share at a price of US$2.10 per common share, subject to adjustment in certain events, until July 20, 2026. If the warrants are fully exercised it will represent approximately $22.5M of additional gross proceeds.

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The Corporation intends to use the net proceeds of the Offering to continue the clinical development of maveropepimut-S (DPX-Survivac) in diffuse large B cell lymphoma (DLBCL), breast cancer, ovarian cancer, bladder cancer and microsatellite instability high (MSI-H), start the clinical development of a new product, DPX-SurMAGE, in bladder cancer, continue the development of its proprietary drug delivery platform (DPX) and for general corporate purposes.

Wells Fargo Securities and Cantor acted as joint book-running managers for the Offering. BTIG acted as lead manager and iA Private Wealth acted as co-manager.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on October 16, 2020 (the "Registration Statement"), and the Corporation’s Canadian final short form base shelf prospectus dated June 26, 2020, as amended on October 15, 2020 (collectively, the "Base Prospectus"). A preliminary prospectus supplement dated July 14, 2021 relating to the Offering has been filed with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States, and a final prospectus supplement dated July 15, 2021 relating to the Offering (the "Supplement") was filed with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States. The Supplement and the accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and the accompanying Base Prospectus can be found for free on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained in the United States from Wells Fargo Securities, Attn: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at (800) 326-5897, or by email at [email protected] or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected], or in Canada from Wells Fargo Securities Canada, Ltd., 22 Adelaide Street West, Suite 2200, Toronto, ON, M5H 4E3, Attn: Akshay Pattni, email: [email protected] or from Cantor Fitzgerald Canada Corporation, Attn: Equity Capital Markets, 181 University Avenue, Suite 1500, Toronto, ON, M5H 3M7, email: [email protected].

This news release 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 province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

On July 20, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will host a conference call and live webcast on Tuesday, August 3, 2021 at 8:30 a.m. Eastern Time to report its second quarter 2021 financial results and recent corporate and portfolio activity (Press release, Kiniksa Pharmaceuticals, JUL 20, 2021, View Source [SID1234585021]).

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A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will be available on Kiniksa’s website for 14 days following the conference. The conference call can be accessed by dialing (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 1485623.

On July 20, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its second quarter 2021 financial results on Tuesday, August 3, 2021 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, JUL 20, 2021, View Source [SID1234584972]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

To access the conference call and webcast, please register at the link below:
View Source

Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

The live webcast of the call and slide deck, may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to [email protected].