On November 9, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its interim financial results in line with guidance for the first nine months of 2018 and business progress for the third quarter of 2018 (Press release, Bavarian Nordic, NOV 9, 2018, View Source [SID1234531089]).

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Highlights

A Biologics License Application for MVA-BN smallpox vaccine (formerly IMVAMUNE) was submitted to the U.S. Food and Drug Administration (FDA). Pending acceptance of the BLA, the Company anticipates approval of the vaccine during 2019 with subsequent filing for a Priority Review Voucher.
IMVANEX smallpox vaccine was supplied to the Public Health England for vaccination of healthcare workers involved in first ever human cases of monkeypox in the U.K.
Following the positive Phase 2 results for our RSV vaccine candidate, MVA-BN RSV, we have initiated discussions with the FDA, which will continue into 2019 with an aim to agree on the design of Phase 3, which we plan to initiate in 2020.
Two studies of our cancer immunotherapy candidate, CV301, in combination with checkpoint inhibitors were initiated. This takes the total number of studies to three, which is in accordance with our strategy to seek rapid proof of concept for the combination of our platform and checkpoint inhibition in three indications. During 2019 we will further advance the potential of our platform by using other routes of administration, which are expected to provide an even broader and more potent anti-tumor response.
A Phase 2 study of BN-Brachyury was initiated in patients with chordoma, a rare cancer in the bones of the skull base and spine with limited treatment options. The vaccine has received orphan drug designation from the FDA for the treatment of chordoma, and the study could potentially provide pivotal results for registration of the vaccine.
Production and deliveries of MVA-BN smallpox vaccine remain on track to fulfil full year guidance.
As planned, Henrik Juuel joined the Company in November as new Chief Financial Officer and member of the executive management.
"The recent BLA submission for our smallpox vaccine highlights the competences and strengths of Bavarian Nordic today, which we proudly apply to advance our technology to develop new vaccines to meet the unmet medical needs that remain in both infectious disease and oncology. We have seen strong progress in our pipeline over the past months with several new studies initiating, seeking proof-of-concept for our immuno-oncology platform across major solid tumor types, but also in rare and underserved cancers, such as chordoma. Following the positive Phase 2 data from our RSV program, we have also recently initiated discussions with the FDA on the design of Phase 3, anticipated to start in 2020. Meanwhile, we continue our successful operations with production of bulk vaccines and construction of our new fill/finish facility going according to plan, securing the foundation for future revenues and success for Bavarian Nordic," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.

Financial results
Financial results for the first nine months were in line with our expectations.

Revenue generated for the nine months ending September 30, 2018 was DKK 319 million/USD 50 million (DKK 1,329 million/USD 206 million in the first nine months of 2017).
The income before interest and tax (EBIT) was a loss of DKK 261 million/USD 41 million (profit of DKK 531 million/USD 82 million in the first nine months of 2017).
As of September 30, 2018, the Group’s cash preparedness was DKK 2,401 million/USD 373 million (DKK 2,604 million/USD 404 million as of December 31, 2017).
Outlook for 2018 maintained
The majority of revenues in 2018 relate to our contract with the U.S. Government for the manufacture of MVA-BN bulk vaccine, all of which have already been produced as of the reporting date. Therefore, we remain on track to fulfill our financial expectations for 2018, with revenues of approximately DKK 500 million/USD 78 million for the full year and a loss before interest and tax (EBIT) of approximately DKK 385 million/USD 60 million. The expected cash preparedness at year-end was upgraded in August from approximately DKK 1,850 million/USD 287 million to approximately DKK 2,100 million/USD 326 million after being granted an unsecured loan facility of EUR 30 million from the European Investment Bank.

Danish kroner (DKK) is the Company’s functional currency. Solely for information purposes, figures above have also been converted into USD using an assumed exchange rate of DKK 6.44 per 1.00 USD, which was the exchange rate as of September 30, 2018.

Anticipated selected pipeline developments

MVA-BN smallpox vaccine

FDA acceptance of the Biologics License Application (BLA) for liquid-frozen MVA-BN (Q4, 2018)
Anticipated FDA approval and award of a Priority Review Voucher (2019)
Initiation of a Phase 3 MVA-BN freeze-dried lot consistency study (H1, 2019)
RSV

Continue discussions with the FDA on the regulatory pathway for approval (H1, 2019)
Initiate Phase 3 study in 2020
Janssen partnership

Initiate Phase 1/2a study of MVA-BN HPV + AdVac (H2, 2018*)
Initiate Phase 1 study of MVA-BN HIV + AdVac (H2, 2018*)
CV301

Report clinical results of NSCLC combination Phase 1/1b (H2, 2018)
Initiate a Phase 1 intra-tumoral administration in patients with solid tumors (H1, 2019)
BN-Brachyury

Report clinical results from Phase 1 study (H2, 2018)
Initiate Phase 1 intravenous administration (H1, 2019)
Report clinical results from Phase 2 in chordoma (H2, 2019)
* Janssen is responsible for the clinical development

Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am EST) to present the interim results followed by a Q&A session. A live and recorded webcast of the presentation can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 35 15 81 21, UK: +44 (0) 330 336 9411, USA: +1 323-794-2551. Participant code is 8332812

On November 9, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, will present at the Canaccord Genuity Medical Technologies & Diagnostics Forum on Thursday, November 15, 2018, at 9:00 a.m. Eastern Time (ET) (Press release, Veracyte, NOV 9, 2018, View Source [SID1234531105]).

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A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On November 8, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that it will be presenting clinical and preclinical data on the company’s next generation AKT inhibitor, ARQ 751, in three poster presentations at the 30th EORTC/AACR/NCI Symposium to be held from November 13 to 16, 2018 in Dublin, Ireland (Press release, ArQule, NOV 8, 2018, View Source [SID1234530928]).

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Presentation Details

Title: A Phase 1 Dose Escalation Study of ARQ 751 in Adult Patients with Advanced Solid Tumors with AKT1, 2, 3 Genetic Alterations, Activating PI3K Mutations, PTEN-null, or Other Known Actionable PTEN Mutations
Abstract #:

395
Session:

Molecular Targeted Agents – PART II
Date:

Friday, November 16, 2018
Time:

10:00-14:00 PM CET
Location:

Exhibition Hall

Title:

Combination of the AKT inhibitor ARQ 751 with Immune Checkpoint Inhibitor and Other Therapeutic Agents
Abstract #:

371
Session:

Molecular Targeted Agents – PART II
Date:

Friday, November 16, 2018
Time:

10:00-14:00 PM CET
Location:

Exhibition Hall

Title:

Miransertib and ARQ 751 exhibit superior cell-death-inducing properties compared to other AKT inhibitors and can overcome resistance to other allosteric AKT inhibitors
Abstract #:

442
Session:

Molecular Targeted Agents – PART II
Date:

Friday, November 16, 2018
Time:

10:00-14:00 PM CET
Location:

Exhibition Hall

About ARQ 751
ARQ 751 is an orally bioavailable, selective small molecule inhibitor of the AKT serine/threonine kinase. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications. ARQ 751 is currently in a Phase 1 study in adult patients with refractory and/or metastatic tumors that harbor genetic alterations along the AKT pathway.

About Miransertib
Miransertib (ARQ 092) is an orally available, selective, pan-AKT (protein kinase B) inhibitor that potently inhibits AKT1, 2 and 3 isoforms. Dysregulation of AKT has been implicated in a variety of rare overgrowth diseases and cancers; however, there are currently no approved inhibitors of AKT. AKT inhibitors, either as single agent or combination therapy, show significant promise in molecularly defined patient populations. Miransertib is currently in a Phase 1/2 company-sponsored study for PIK3CA-Related Overgrowth Spectrum (PROS), a Phase 1 study for ultra-rare Proteus syndrome conducted by the National Institutes of Health (NIH/NHGRI), and a Phase 1b study in combination with the hormonal therapy, anastrozole, in patients with advanced endometrial cancer with AKT and PI3K mutations. Miransertib has been granted Rare Pediatric Disease Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA), as well as Orphan Designation by the FDA and European Medicines Agency in the rare overgrowth disease, Proteus syndrome.

On November 8, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that it will present at the 2018 Canaccord Genuity Medical Technologies and Diagnostics Forum in New York City on Thursday, November 15, 2018 at 9:30 a.m. Eastern Time (Press release, Genomic Health, NOV 8, 2018, View Source;diagnostics-forum-300746203.html [SID1234531043]).

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To access the live and subsequently archived webcast of the presentation, go to the Investor Relations section of the company’s web site at View Source Please connect to the web site at least 15 minutes prior to the presentation to allow for any software download that may be necessary. An archived replay will be available for three months beginning 24 hours after the live presentation.

On November 8, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of people with cancer, reported operating results for the third quarter ended September 30, 2018 and recent highlights from its development program for Vicinium for patients with high-grade non-muscle invasive bladder cancer (NMIBC) (Press release, Eleven Biotherapeutics, NOV 8, 2018, View Source [SID1234531409]).

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"2018 has been a year of focused execution for Sesen Bio, led by the advancement of the Phase 3 program for Vicinium for patients with NMIBC," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "NMIBC is a devastating disease and there remains just one recommendation for patients who do not respond or become refractory to today’s standard-of-care treatment: complete bladder removal. Our goal is to help save this essential organ and provide a meaningful treatment option for patients with BCG-unresponsive NMIBC. Our Phase 3 registration clinical trial is well-designed and preliminary data reported earlier this year suggest that Vicinium is active and has a favorable safety profile, consistent with our Phase 2 experience. We look forward to assessing six-month data from the trial next month and twelve-month data in mid-2019. If the VISTA Trial is successful, we believe Viciniumcould change the treatment outlook for patients with NMIBC, bringing us closer to achieving our mission of saving and renewing the lives of patients with cancer."

Recent Highlights

In September 2018, at the Global Congress on Bladder Cancer 2018, Sesen Bio presented a biomarker update from its Phase 3 VISTA Trial data showing that all screened patient samples expressed EpCAM, the molecular target of Vicinium.
In October 2018, the company entered into an agreement with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. to provide supply services in support of the manufacturing of Vicinium for the treatment of high-grade NMIBC. The Agreement facilitates a transfer of manufacturing technology from Sesen Bio to Fujifilm.
Upcoming Events

Sesen Bio anticipates reporting six-month data from the ongoing Phase 3 VISTA Trial in December 2018. A conference call will be held to review the data, with details to follow.
Third Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $57.9 million as of September 30, 2018, compared to $11.3 million as of September 30, 2017.
Revenue: There was no revenue for the three-month periods ended September 30, 2018 and 2017, respectively, as no revenue triggering milestones were achieved during either period under the company’s license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
R&D Expenses: Research and development expenses were $3.4 million for the three months ended September 30, 2018, compared to $3.6 million for the same period in 2017. The decrease was due primarily to a reduction in Vicinium-related development expenses.
G&A Expenses: General and administrative expenses were $3.8 million for the three months ended September 30, 2018, compared to $1.6 million for the same period in 2017. The increase was due primarily to an increase in professional fees as well as higher personnel-related expenses.
Net Loss: Net loss was $14.0 million, or $0.18 per share, for the three months ended September 30, 2018, compared to net loss of $9.1 million, or $0.37 per share, for the same period in 2017. The increase was due primarily to the change in the fair value of contingent consideration and increased general and administrative expenses.
Financial Guidance: Based on current operating plans, Sesen Bio believes it will have capital sufficient to fund its current operating plans into 2020.