On May 22, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported a plan to focus its research and development investments on advancing on-going and previously announced clinical trials for its innate cell engager candidates, AFM13 and AFM24 (Press release, Affimed, MAY 22, 2019, View Source [SID1234536527]). As part of the strategic plan, Affimed will terminate the Phase 1 clinical program of AFM11, a CD19/CD3-targeting bispecific T cell engager. The Company also provided an update on recent operational progress and reported financial results for the quarter ended March 31, 2019.

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"We are focused on advancing our CD16A-targeting innate cell engager product candidates as we progress through 2019, with the goals of initiating a market registration-directed study of AFM13 and entering the clinic with AFM24," said Dr. Adi Hoess, Affimed’s CEO. "We strongly believe our innate cell engagers could enhance current immuno-oncology approaches and address unmet patient needs in treating hematologic and solid tumor malignancies. We have determined that the optimal use of our resources at this time is to advance our innate cell engagers, focusing their development on indications with high unmet need and the potential for a rapid path to regulatory approval. In addition to advancing our current clinical product candidates, we are working toward expanding our early clinical stage pipeline and exploring rational combinations of our innate cell engagers with other therapeutic modalities such as adoptive NK cell therapies."

Corporate Updates
Affimed received a milestone payment from Genentech, a member of the Roche Group, triggered by the achievement of a preclinical milestone under its research collaboration with Genentech to develop and commercialize novel natural killer (NK) cell engager-based immunotherapeutics based on Affimed’s ROCK platform to treat multiple cancers.
Dr. Martin Treder has informed Affimed that he intends to step down from his position as Chief Scientific Officer to pursue new opportunities. Dr. Treder will continue as a consultant to the Company.
Dr. Hoess commented, "Martin oversaw the development of Affimed’s ROCK platform. We thank Martin for his many contributions to Affimed during his tenure as CSO, and wish him success in his future endeavors."

Pipeline Updates and Upcoming Clinical Plans
CD16A innate cell engager programs

AFM13 (CD30/CD16A)

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, Affimed together with its collaboration partners from Washington University School of Medicine, St. Louis, MO, presented data that describe functional responses of conventional and cytokine-induced memory-like (CIML) NK cells in the presence or absence of AFM13. In a poster titled, "The CD30/CD16A bispecific innate immune cell engager AFM13 elicits heterogeneous single cell NK cell responses and effectively triggers memory like (ML) NK cells," preclinical data showed that AFM13 significantly enhanced NK cell recognition of CD30-positive tumor cells and this enhanced tumor recognition correlated with superior NK cell activation. In the study, the combination of CIML NK cells with AFM13 potentiated cytokine secretion and cytotoxicity towards tumor target cells, further demonstrating the rationale for combining AFM13 with adoptive NK cell-based therapies as a promising therapeutic approach for treating CD30-positive malignancies.
Abstracts providing updates on AFM13 clinical studies have been accepted for oral and poster presentations at the 15th International Conference on Malignant Lymphoma (ICML), to be held from June 18-22, 2019, in Lugano, Switzerland. The oral presentation includes updated data from the combination study of AFM13 with Merck’s Keytruda (pembrolizumab) in patients with relapsed or refractory Hodgkin lymphoma (HL). In addition, a poster presentation will highlight data from the investigator-sponsored study of AFM13 as monotherapy in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestations. Details on these presentations are expected to be available in mid-June through the ICML meeting website at www.lymphcon.ch.
Affimed filed with U.S. Food and Drug Administration (FDA) the full study protocol for the Company’s Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with peripheral T cell lymphoma (PTCL) and transformed mycosis fungoides, a subset of cutaneous T cell lymphoma. The study commencement is targeted for the second half of 2019 pending agreement with the FDA on the final study protocol.
An investigator-sponsored study directed towards development of an off-the-shelf adoptive immunotherapy comprised of AFM13 pre-mixed with expanded cord blood-derived allogeneic NK cells in patients with relapsed/refractory CD30-positive malignancies is planned by The University of Texas MD Anderson Cancer Center (MDACC) with the support of Affimed.
AFM24 (EGFR/CD16A)

At the AACR (Free AACR Whitepaper) Annual Meeting 2019, a poster titled, "Preclinical characterization of the bispecific EGFR/CD16A innate immune cell engager AFM24 for the treatment of EGFR-expressing solid tumors," highlighted potentially differentiating features of AFM24 versus standard of care anti-EGFR therapies, such as the monoclonal antibody cetuximab. AFM24 demonstrated the ability to bridge NK cells and macrophages to EGFR expressing tumor cell lines, and induced lysis through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively, which was independent of RAS mutational status. AFM24 enhanced tumor infiltration of NK cells and elicited dose-dependent anti-tumor efficacy in in vivo tumor models. Importantly, AFM24 showed reduced inhibition of EGFR phosphorylation relative to the standard of care, cetuximab. Treatment of cynomolgus monkeys with AFM24 showed a favorable safety profile, even when treated at high dose levels, demonstrating AFM24’s potential to have significantly lower toxicities in humans compared to standard of care.
Affimed currently anticipates completing investigational new drug (IND)-enabling studies of AFM24 by mid-year 2019 to support the initiation of the first-in-human study of AFM24 in the second half of 2019.
Financial Highlights
(Figures for the first quarter of 2019 and for the first quarter 2018 are unaudited.)

Pro-forma cash, cash equivalents and short-term deposits, including the milestone payment under the Genentech collaboration that the Company received in April 2019, totaled €100.4 million or approximately $113 million, as of March 31, 2019. Cash, cash equivalents and short-term deposits on December 31, 2018 were €108.8 million. Based on its current operating and budget assumptions, Affimed anticipates that its cash, cash equivalents and short-term deposits as of March 31, 2019 will enable the Company to fund its planned clinical development and early development activities into 2021.

Net cash used in operating activities was €13.4 million for the three months ended March 31, 2019 compared to net cash used in operating activities of €6.9 million for the three months ended March 31, 2018. Total revenue was €11.4 million for the three months ended March 31, 2019 compared to €0.5 million for the three months ended March 31, 2018. The increase in revenue is primarily attributable to the recognition of €10.6 million as revenue from the Genentech collaboration in the first quarter of 2019.

Research and development (R&D) expenses for the first quarter of 2019 were €8.0 million compared to €6.4 million for the first quarter of 2018. The increase was primarily related to higher expenses related to clinical study startup activities for the AFM13 registration study in PTCL, as well as early stage development and discovery activities.

General and administrative (G&A) expenses for the first quarter of 2019 were higher at €2.4 million compared to €2.0 million for the first quarter of 2018. This increase was primarily related to higher personnel expenses. Net income was €1.9 million, or €0.03 per common share, for the first quarter of 2019, compared to a net loss of €8.2 million, or €0.15 per common share, for the first quarter of 2018. Net income was primarily related to significantly increased revenue, partially offset by higher R&D and G&A expenses.

Note on IFRS Reporting Standards
Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed will host a conference call and webcast today, Wednesday, May 22, 2019 at 8:30 a.m. Eastern time to discuss the company’s financial results and recent corporate developments. To access the call, please dial +1 (631) 510-7495 for U.S. callers, or +44 (0) 2071 928000 for international callers, and reference conference ID 1083705 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived for 30 days following the call.

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

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."

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.

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.