Bavarian Nordic Announces Interim Results for the First Three Months of 2019

On May 22, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its interim financial results and business progress for the first three months of 2019 (Press release, Bavarian Nordic, MAY 22, 2019, View Source [SID1234536526]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "As outlined in our strategy, 2019 and 2020 will be transitional years for Bavarian Nordic with significant investments in R&D and our new fill and finish facility, all with the objective to secure future revenue, growth and profitability. We have prepared for an eventful year, and while we have already shared several news during the first quarter, there are more exciting news to come, including the anticipated first U.S. approval, which will solidify our position as the global leader in the smallpox vaccine space and create new commercial opportunities ahead. Also, the approval will trigger the award of a Priority Review Voucher which, when sold, will contribute to maintaining a strong financial position. We also look forward to presenting a finalized plan for Phase 3 development of our RSV vaccine, and to report Phase 2 data from our immuno-oncology programs later this year. So, we are moving forward within all four strategic pillars of the company as planned and are reporting a first quarter fully in line with our expectations and guidance, both financially and operationally."

OPERATIONAL HIGHLIGHTS

Delivering our strategy

Our strategy is four-fold, and aims to secure and reinforce a sustainable foundation, while also expanding the commercial opportunities:

MAINTAIN global leadership of our smallpox vaccine business
EXPAND and rapidly ADVANCE the pipeline of infectious disease programs
ESTABLISH a broad and deep cancer immunotherapy portfolio
EXPAND the commercial footprint and capabilities
Smallpox

We have seen continued strong progress for our smallpox vaccine program, reinforcing our global leadership position.
The approval of the liquid-frozen formulation and award of a Priority Review Voucher are anticipated in September of 2019.
We have continued manufacturing for the ongoing contract for freeze-dried MVA-BN and will have produced bulk vaccine worth USD 333 million by year-end, of which USD 50 million are part of our 2019 revenues.
In January, we were awarded USD 44 million by the U.S. Government for qualification of our new fill and finish facility, as well as for transfer and validation of the production process for freeze-dried MVA-BN, which are all activities that will occur during 2020 before starting production of the current order (conversion of bulk vaccine to approx. 13 million final vaccine doses).
The pivotal Phase 3 lot consistency trial of the freeze-dried formulation of MVA-BN is planned to initiate in the second quarter of 2019. Based on the successful completion of this trial, we expect to submit a BLA supplement in 2021 with anticipated approval in 2022 of freeze-dried MVA-BN.
Infectious diseases

We remain at the forefront of RSV vaccine development with our differentiated, broad-spectrum vaccine candidate, which has successfully concluded Phase 2 development in elderly. We are currently in discussions with U.S. regulatory authorities on licensure requirements and expect to outline the Phase 3 development plan around mid-2019.
In February, our partner Janssen initiated a Phase 1/2a of the therapeutic HPV vaccine regimen. This is the first of three commercial programs under our partnership to initiate clinical trials. The second program, HIV, is also expected to initiate clinical trials later this year. Collectively, these programs, along with our Ebola collaboration represent USD 1 billion in potential future milestone payments, in addition to royalties on future sales.
Our partnership with the U.S. Department of Defense on the development of a prophylactic vaccine against the equine encephalitis virus – a rare, but potentially deadly illness – further evolved, as we received funding to support a Phase 1 clinical trial, which we expect to initiate later this year. Successful trial results could lead to additional funding of clinical development towards licensure.
Cancer immunotherapy

In January, our pivotal Phase 2 trial of BN-Brachyury for the treatment of chordoma completed the recruitment of patients for the first stage ahead of schedule. The first results from this study are expected by the end of this year.
Our other immune-oncology candidate, CV301, is currently subject of three Phase 2 trials in multiple cancers, where the vaccine is combined with different immune checkpoint inhibitors. The first results from one of these trials, where CV301 is combined with atezolizumab in bladder cancer, is expected to become available later in 2019.
Both vaccine candidates will be employed in new trials later this year to investigate new routes of administration as part of our strategy to further enhance our immuno-oncology platform.
Commercial

Construction of our fill and finish facility is progressing according to plan, and we expect the building to be completed by end of 2019, which is also the peak investment year with approximately DKK 270 million in total investments. Subsequently, qualification and validation activities will begin and continue into late 2020 before initiating production.
FINANCIALS AND OUTLOOK

Financial results for the first quarter in line with expectations

Revenue generated for the three months ending March 31, 2019 was DKK 127 million/USD 19 million (DKK 11 million/USD 2 million in the first three months of 2018).
The income before interest and tax (EBIT) was a loss of DKK 104 million/USD 16 million (loss of DKK 173 million/USD 26 million in the first three months of 2018.
As of March 31, 2019, the Group’s cash preparedness was DKK 2,172 million/USD 327 million (DKK 2,314 million/USD 327 million as of December 31, 2018), including unutilized credit lines of DKK 244 million/USD 37 million (DKK 244 million/USD 37 million as of December 31, 2018).
Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.64 per 1.00 USD, which was the exchange rate as of March 31, 2019.

Outlook for 2019 maintained

We maintain our financial expectations for 2019 as announced on March 21, 2019 with revenues of approximately DKK 600 million/USD 92 million for the full year, a loss before interest and tax (EBIT) of approximately DKK 360 million/USD 55 million and a cash preparedness at year-end of approximately DKK 1,600 million/USD 246 million.

While the Company anticipates the award of a Priority Review Voucher upon the expected approval of MVA-BN smallpox vaccine by the FDA in 2019, income from the sale of this voucher has not been included in the guidance.

The financial expectations are based on an exchange rate of DKK 6.50 per 1.00 USD. For further details regarding assumptions behind the guidance see the Annual Report 2018.

Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CEST (8 am EST) 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 3096344.

Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43

Graham Morrell
Paddock Circle Advisors (US)
[email protected]
Tel: +1 781 686 9600

Company Announcement no. 08 / 2019

Personalis, Inc. to Provide Tumor Immunogenomic Profiling to the Parker Institute for Immunotherapy Biomarker Discovery in Clinical Trial Participants

On May 22, 2019 Personalis, Inc., a leader in advanced genomics for cancer, reported that the Parker Institute for Cancer Immunotherapy will utilize Personalis’ cancer immunogenomics platform, ImmunoID NeXT, for the investigation of biomarkers of response to immunotherapies in clinical trial participants (Press release, Personalis, MAY 22, 2019, View Source [SID1234536523]). The trials include melanoma, pancreatic, and all-comer solid tumor patients treated with checkpoint inhibitors, either as monotherapy or in combination with other cancer therapeutics. This project builds on Personalis’ existing relationship with the Parker Institute as a contributing industry member of the TESLA Consortium, which focuses on improving neoantigen prediction algorithms.

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Unlike traditional biomarker interrogation approaches that require several individual assays, which may be costly and time-consuming, and which may exhaust limited tumor tissue sample, ImmunoID NeXT consolidates multiple biomarker assays into one, meaning researchers no longer need to make the difficult choice regarding which biomarkers to analyze. The platform represents an end-to-end solution for immuno and precision oncology biomarker discovery applications, simultaneously enabling the analysis of: tumor mutations, neoantigens, immune repertoire clonality, tumor escape mechanisms (including HLA-related somatic mutations and genotyping), tumor mutational burden (TMB), microsatellite instability (MSI), oncoviruses, and more.

"Personalis’ platform could help us better understand which patients will respond or not respond to immunotherapy and why," said Theresa LaVallee, PhD, VP Translational Medicine and Regulatory Affairs at the Parker Institute.

"We’re excited to work with the Parker Institute on this important new project," said Dr. Richard Chen, MD, Personalis’ Chief Scientific Officer. "Both organizations are focused on improving outcomes for cancer patients, and we believe that ImmunoID NeXT is the catalyst that our partners and customers can leverage to discover more effective biomarkers of response to immunotherapies."

OncoSec Medical Incorporated Prices $11,000,000 Public Offering

On May 22, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a late-stage cancer biotechnology company developing intratumoral gene-delivery immunotherapies, reported the pricing of an underwritten public offering led by fundamental, healthcare institutional investors consisting of 3,492,063 shares of Common Stock together with Warrants to purchase up to 2,619,047 shares of Common Stock at a combined price to the public of $3.15 (Press release, OncoSec Medical, MAY 22, 2019, View Source [SID1234536522]). The Warrants will have an exercise price of $3.45, will be exercisable upon issuance and will expire five years from the date of issuance. The gross proceeds to the Company from this offering are expected to be approximately $11,000,000 before deducting underwriting discounts, commissions and other offering expenses. OncoSec has granted the underwriter a 45-day option to purchase additional shares of Common Stock and/or additional Warrants to cover over-allotments, if any. The offering is expected to close on May 24, 2019, subject to customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-213036) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2006 or email: [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that OncoSec has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about OncoSec and such offering.

This press 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 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 jurisdiction.

Iovance Biotherapeutics Announces Breakthrough Therapy Designation for LN-145 for Treatment of Advanced Cervical Cancer Patients Who Have Progressed on or After Chemotherapy

On May 22, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Iovance TIL therapy candidate LN-145 in recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy (Press release, Iovance Biotherapeutics, MAY 22, 2019, View Source [SID1234536521]).

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"We are very excited that the FDA has granted LN-145 in advanced cervical cancer Breakthrough Therapy designation. Cervical cancer patients who have progressed on or after chemotherapy have limited treatment options. We hope to bring LN-145 to these patients as quickly as possible," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance. "The designation allows us to expedite our development program through more frequent interactions with the FDA and provides eligibility for rolling review and priority review."

Breakthrough Therapy designation (BTD) is designed to expedite the development and review of therapeutic candidates intended to treat serious or life-threatening diseases in the case where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The FDA decision on BTD for LN-145 in advanced cervical cancer was based on clinical data from the ongoing innovaTIL-04 (C-145-04) trial. The company will present the data on June 1, 2019, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Halozyme Announces argenx Has Selected Second Target Under ENHANZE® Technology Collaboration And License Agreement

On May 22, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that argenx has selected a second target under the collaboration and license agreement the companies announced in February 2019 (Press release, Halozyme, MAY 22, 2019, View Source [SID1234536520]).

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The second target selected for development by argenx is human complement factor C2 associated with the product candidate ARGX-117, which is being developed to treat severe autoimmune diseases. Halozyme will receive a $10 million milestone payment during the current quarter from argenx for this target nomination and potential future payments of up to $160 million subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on future commercial sales products. argenx has now selected two targets for development and can select one additional target in the future according to the terms of the collaboration and license agreement.

"We are excited about this opportunity to expand our partnership with argenx," said Dr. Helen Torley, president and chief executive officer. "Planning is well underway for the second half 2019 phase 1 study initiation for the first selected target, FcRn. This second development stage target to be used with our ENHANZE drug delivery technology is yet another example of the potential for ENHANZE to provide dosing optionality for patients. We look forward to continuing our work with argenx as they seek to improve the lives of patients suffering with severe autoimmune diseases."

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.