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]).

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!

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.

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.

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!

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 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported that management will present a company overview at the Raymond James Human Health Innovation Conference being held virtually Monday, June 21st – Wednesday, June 23rd, 2021 (Press release, OncoSec Medical, MAY 27, 2021, View Source [SID1234580696]).

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!

Raymond James Human Health Innovation Virtual Conference
Date: Monday, June 21st
Time: 12:00pm ET

For those not attending the conference, a replay of the presentation will be available for 90 days in the "Events & Presentations" section of OncoSec’s website at View Source

On May 27, 2021 eFFECTOR Therapeutics, Inc. (eFFECTOR), a biopharmaceutical company focused on pioneering the development of selective translation regulation inhibitors (STRIs) for the treatment of cancer, and Locust Walk Acquisition Corp. (NASDAQ: LWAC), a blank-check company formed for the purpose of acquiring or merging with one or more businesses, reported they have entered into a definitive merger agreement (Press release, eFFECTOR Therapeutics, MAY 27, 2021, View Source [SID1234580695]). Upon closing of the transaction, anticipated to occur in the third quarter of 2021, the combined company will be named eFFECTOR Therapeutics, Inc. and will be led by Steve Worland, Ph.D., president and CEO. The combined company’s common stock is expected to be listed on the Nasdaq Capital Market under the ticker symbol "EFTR".

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!

"This milestone is the beginning of a significant new chapter in eFFECTOR’s history, as we build on our strong scientific foundation as leaders in the development of selective translation regulator inhibitors as a new class of therapies for cancer," said Dr. Worland. "We’re entering into this transaction to accelerate eFFECTOR’s growth with the goal of delivering a new class of medicines to help drive improved health outcomes for people with cancer. We are excited to be selected by the management and board of LWAC, whose members have vast experience as investors and operating executives in the biotechnology industry."

"After evaluating more than 90 biotech companies, eFFECTOR emerged as the best choice for our business combination," stated Chris Ehrlich, CEO and director of LWAC. "eFFECTOR is at the cutting-edge of targeting translation regulation, which has the potential to simultaneously address multiple drivers of cancer. We are confident that the highly experienced management team with a track record of pipeline advancement and business accomplishments are prepared to lead eFFECTOR as a publicly listed company. This transaction positions eFFECTOR to reach important value inflection points for our impressive list of stakeholders."

The transaction includes up to $175 million in trust at LWAC (less any redemptions by existing LWAC stockholders) and a concurrent, fully committed $60 million PIPE financing of common stock issued at $10.00 per share from new and existing leading healthcare investors including founding Series A investors Abingworth, SR One, The Column Group and U.S. Venture Partners, as well as Altitude Life Science Ventures, Sectoral Asset Management, Pfizer Ventures, Alexandria Venture Investments, BioMed Ventures and Osage University Partners.

Proceeds from the transaction are expected to provide eFFECTOR with the capital to further develop its pipeline, advancing it through multiple clinical milestones, including the following:

Report topline data from the randomized Phase 2b KICKSTART clinical trial of eFFECTOR’s lead product candidate, tomivorsertib, an oral small-molecule inhibitor of mitogen-activated protein kinases 1 and 2 (MNK) 1/2, in combination with pembrolizumab in metastatic non-small cell lung cancer (NSCLC), both in the frontline extension and frontline settings; this study is open for enrollment.
Initiate multiple Phase 2a expansion cohorts for zotatifin, a small-molecule inhibitor of eIF4A, in patients with breast cancer and NSCLC in the second half of 2021.
Support expansion of both tomivosertib and zotatifin into additional indications.
Key Transaction Terms

Upon the closing of the business combination, and assuming no redemptions of shares of LWAC by its public stockholders, eFFECTOR would be expected to have cash resources of approximately $210 million (less any redemptions), and a total enterprise valuation of $419 million.

The boards of directors of both eFFECTOR and LWAC have unanimously approved the proposed transaction, which is expected to be completed in the third quarter of 2021. The closing of the transaction is subject to approval of LWAC shareholders and the satisfaction or waiver of certain other customary closing conditions.

Additional information about the transaction will be provided in a Current Report on Form 8-K to be filed by LWAC with the Securities and Exchange Commission (SEC) and will be available on the SEC’s website at www.sec.gov. In addition, LWAC intends to file a registration statement on Form S-4 with the SEC, which will include a proxy statement/prospectus, and will file other documents regarding the proposed transaction with the SEC.

Advisors

Credit Suisse and Stifel are acting as lead PIPE placement agents, and Credit Suisse is also acting as capital markets advisor to eFFECTOR. Locust Walk Securities is also acting as PIPE placement agent. Latham & Watkins LLP is acting as legal counsel to eFFECTOR. Cantor Fitzgerald is acting as the lead capital markets advisor to LWAC. JMP Securities and Mizuho Securities are also acting as capital markets advisors to LWAC. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to LWAC.

Investor Webcast

The management teams of eFFECTOR and LWAC will host a webcast today, Thursday, May 27 at 9:00 a.m. ET to provide a brief overview of eFFECTOR and the proposed transaction. The webcast can be accessed here: View Source

On May 27, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its participation at three upcoming virtual investor conferences (Press release, TG Therapeutics, MAY 27, 2021, View Source [SID1234580694]). Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, is scheduled to participate in the following:

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!

Jefferies Virtual Healthcare Conference: Fireside chat scheduled to take place on Tuesday, June 1, 2021, at 2:00 PM ET
Goldman Sachs 42nd Annual Global Healthcare Conference: Fireside chat scheduled to take place on Tuesday, June 8, 2021, at 1:20 PM ET
Raymond James Human Health Innovation Conference: Presentation scheduled to take place on Tuesday, June 22, 2021, at 10:00 AM ET
A live webcast of each presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source Following each event, an archive file will be available for thirty days.