On May 27, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported the initiation of a new share buy-back program, under which the Company intends to buy back up to 31,747 of its own shares (Press release, Bavarian Nordic, MAY 27, 2021, View Source;text=COPENHAGEN%2C%20Denmark%2C%20May%2027%2C,31%2C747%20of%20its%20own%20shares. [SID1234580701]). The purpose of the share buy-back program is to meet the Company’s obligations arising from the share-based incentive programs for the Board of Directors and Executive Management, in accordance with the Company’s remuneration policy.

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The share buy-back program is initiated pursuant to the authorization granted at the annual general meeting on April 20, 2021, according to which the Company may purchase up to 10 % of the Company’s share capital for the time being.

The share buy-back program will be executed in accordance with Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse and supplementing Regulation (EU) 2016/1052 of 8 March 2016, which together constitute the Safe Harbour Regulation.

Bavarian Nordic A/S has appointed Danske Bank A/S Lead Manager of the program. Danske Bank A/S will buy back shares on behalf of Bavarian Nordic A/S and make decisions on trading with Bavarian Nordic A/S’ shares independently and without influence of Bavarian Nordic A/S.

The program will be implemented in accordance with the authorization within the following scope:

A maximum of 31,747 shares will be bought back within the duration of the program.
The maximum consideration for Bavarian Nordic A/S-shares bought back within the duration of the program is DKK 13 million. However, based on yesterday’s closing price of Bavarian Nordic’s share on Nasdaq Copenhagen A/S, the total consideration is expected to be in the level of DKK 8.7 million.
The program terminates at the latest on June 4, 2021.
The maximum number of shares, which may be purchased per trading day, shall not exceed 25% of the average daily volume of shares in the Company traded on Nasdaq Copenhagen A/S in the preceding 20 trading days.
The shares may not be purchased at a price which is higher than the higher of the following:
The price of the last independent trade.
The highest current independent purchase bid on Nasdaq Copenhagen A/S.
Bavarian Nordic A/S may terminate the program at any time. If the Company determines to terminate the program, the Company will give notice hereof.

On May 27, 2021 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that Bassil Dahiyat, Ph.D., president and chief executive officer, will present a corporate overview at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 1:00 p.m. ET / 10:00 a.m. PT (Press release, Xencor, MAY 27, 2021, View Source [SID1234581380]).

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A webcast will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Following the webcast, a replay will be archived on the website for at least 30 days.

On May 27, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in the following virtual investor conferences in June (Press release, Bicycle Therapeutics, MAY 27, 2021, View Source [SID1234580668]):

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Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021; fireside chat at 11:00 a.m. ET
Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021; fireside chat at 8:00 a.m. ET
The JMP Securities Life Sciences Conference on Thursday, June 17, 2021; fireside chat at 12:00 p.m. ET
A live webcast of the fireside chats will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available for 30 days following the presentation dates.

On May 27, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, reported financial results for the first quarter 2021 (Press release, Biomea Fusion, MAY 27, 2021, View Source [SID1234580686]).

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"I could not be more proud of Team Fusion and what we have achieved scientifically and operationally during this past quarter," said Thomas Butler, Biomea’s CEO and Chairman of the Board. "We continue to execute at a very high level and are on track to submit our IND application to the FDA for BMF-219 during the second half of this year. We believe that menin will become a cornerstone therapeutic target for cancer treatments, and our approach to disrupt this scaffold protein through irreversible inhibition will afford us a profound opportunity to create effective and patient-friendly therapies for some of today’s most untreatable cancers. Over just a four month period, we were able to complete a Series A financing in December 2020 and our recent IPO in April, raising a combined total of $223 million in aggregate gross proceeds. Our strong balance sheet provides us today with ample funding to fully explore the potential of BMF-219 in multiple tumor types, comprehensively build out our proprietary irreversible platform, and progress multiple early-stage small pipeline molecules into the clinic. During the same period, we also doubled the size of our team, bringing in extremely talented but also friendly and passionate people."

Business Highlights

Completed initial public offering ("IPO") in April. The Company’s common stock commenced trading on the Nasdaq Global Select Market under the ticker symbol "BMEA" on April 16, 2021. The IPO, at a public offering price of $17.00 per share, raised $167 million in aggregate gross proceeds, including shares sold to the underwriters pursuant to the exercise of their option to purchase additional shares in May 2021. As of April 30, 2021, there were 28,767,867 shares of common stock outstanding.

Continue to advance lead program, BMF-219, toward the clinic. Biomea continues to progress BMF-219, an irreversible menin inhibitor for the treatment of menin-dependent cancers. Biomea anticipates filing an investigational new drug (IND) application in the second half of 2021. The company has two additional programs pursuing undisclosed targets, which are currently in the discovery phase.

Strengthened the Board of Directors. In the first quarter Biomea added Mick Hitchcock, Ph.D., former senior advisor to Gilead, who brings 40 years of biotech experience in drug development and commercialization to its board of directors.
Financial Highlights

First Quarter 2021 Financial Results

Biomea reported a net loss attributable to common stockholders of $5.9 million for the first quarter of 2021, compared to a net loss of $0.4 million for the same period in 2020.
Research and development expenses were $3.8 million for the three months ended March 31, 2021, compared to $0.3 million for the same period in 2020. The increase in R&D expenses was primarily due to an increase in pre-clinical development activities for BMF-219 and higher personnel-related expenses.
General and administrative expenses were $2.1 million for the three months ended March 31, 2021, compared to $0.1 million for the same period in 2020. The increase in G&A expenses was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations.
As of March 31, 2021, the Company had cash, cash equivalents, restricted cash, and investments of $57.5 million.

On May 27, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its interim financial results and business progress for the first three months of 2021 (Press release, Bavarian Nordic, MAY 27, 2021, View Source [SID1234580702]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "It has been an eventful quarter for Bavarian Nordic with continued progress in the commercialization of the Company. This is driven by the acquired product portfolio from GSK, our smallpox vaccine business, and several new supply contracts, but importantly, also with significant advances in our pipeline. We have initiated the human challenge trial of the RSV vaccine as planned and look forward to results later this year. Following the announcement of encouraging preclinical results for the COVID-19 vaccine, which demonstrated the potential for a broad protection against emerging SARS-CoV2 variants, we will soon advance the project by initiating a larger phase 2 trial and are working to secure funding for phase 3 development towards licensure. We remain optimistic about the gradual reopening of the society and maintain our financial guidance for 2021, although markets are still uncertain due to COVID-19."

Financial highlights from the first quarter

Revenue was DKK 535 million comprised of DKK 515 million from combined product sales and DKK 20 million from contract work.
EBITDA was DKK 1 million.
Strong cash position of DKK 2,589 million at end of the period, excluding unutilized credit facilities of DKK 244 million.
Full-year guidance maintained with expected revenue between DKK 1,900-2,200 million, EBITDA between DKK 100-250 million and securities, cash and cash equivalents at year-end between DKK 1,400-1,600 million. The guided ranges reflect the uncertainty created by COVID-19 in the rabies and tick-bore encephalitis markets.

* EBITDA in Q1 2020 was positively impacted by the sale of the Priority Review Voucher.

Other highlights

In January, Bavarian Nordic announced contracts with three European countries for the supply of smallpox vaccines. Deliveries occurred during the first quarter 2021.
In March, Bavarian Nordic received a new order from the Canadian Government for smallpox vaccines valued at USD 31 million for delivery in 2022 and 2023. The order was made under an existing contract with the Public Health Agency of Canada.
In March, Bavarian Nordic reported encouraging preclinical data for the COVID-19 vaccine candidate, ABNCoV2 and subsequently raised DKK 1.1 billion through a private placement to, among others, advance the clinical development of the vaccine towards licensure.
Events after the reporting date

In April, new preclinical results for the COVID-19 vaccine candidate, ABNCoV2 were announced, confirming its potential to offer broad protection against variants of the SARS-CoV2 virus.
In April, Bavarian Nordic received a new Ebola supply order from Janssen, valued at approximately USD 28 million. Manufacturing and delivery will occur during 2021. The Johnson & Johnson Ebola vaccine regimen, which includes Mvabea from Bavarian Nordic also received Prequalification from the World Health Organization, which along with the July 2020 approval from the European Commission, will help accelerate its registration in countries where Ebola is a persistent public health threat.
In May, the US government exercised the final USD 12 million option remaining under the USD 202 million order for JYNNEOS awarded in April 2020.
In May, Bavarian Nordic entered an agreement with Dynavax on marketing and distribution of their HEPLISAV B hepatitis B vaccine in Germany
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 1 pm CET (7 am ET) to present the interim results followed by a Q&A session. A listen-only version of the call can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 3319667.