Pieris Pharmaceuticals Reports Full-Year 2017 Financial Results and Corporate Update

On March 9, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that financial results for its fiscal year ended December 31, 2017, and provided a corporate update (Press release, Pieris Pharmaceuticals, MAR 9, 2018, View Source [SID1234524603]):

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PRS-343: Pieris continues to advance PRS-343, a tumor-targeted 4-1BB-based immuno-oncology (IO) bispecific, through a phase 1, dose-escalation study, with initial safety, tolerability, pharmacokinetic and pharmacodynamic data expected in the second half of 2018. This program is the first bispecific T cell costimulatory agonist to enter clinical development.
PRS-060: The company continues to enroll healthy subjects in a first-in-human study for PRS-060, an IL-4 receptor alpha antagonist, which began during the fourth quarter of 2017. PRS-060 is the lead product in the company’s respiratory alliance with AstraZeneca. Pieris is sponsoring the phase 1 study, while AstraZeneca is responsible for funding its costs. Initial data from the phase 1 study are expected in the fourth quarter of 2018. AstraZeneca will sponsor and continue to fund clinical development of PRS-060 through phase 2a, after which the company may exercise an option to co-develop PRS-060. Pieris also has an option for U.S. co-commercialization rights for this program.
PRS-080: Pieris continues to enroll dialysis-dependent patients with functional iron deficiency anemia in a phase 2a study for PRS-080. Pieris intends to report safety and pharmacodynamic data from this study, including the change in hemoglobin levels after five weekly doses of PRS-080, in the second half of 2018. If data are positive, the company will seek to partner PRS-080 in territories outside of those for which ASKA Pharmaceutical Co. has an exclusive option (Japan and certain other Asian territories).
Seattle Genetics Collaboration: On February 9, 2018, the company announced a multi-program IO-focused alliance with Seattle Genetics. The collaboration leverages the expertise and core technologies of both companies to develop novel Antibody-Anticalin bispecific fusion proteins utilizing Seattle Genetics’ tumor-targeted monoclonal antibodies and Pieris’ costimulatory engaging Anticalin proteins. Under the collaboration, Seattle Genetics will pay Pieris a $30 million upfront fee. Pieris has the potential to receive up to $1.2 billion in success-based payments in addition to royalties up to the double digits in connection with the sales of commercialized products, as well as an option to co-develop and commercialize one of the programs in the U.S.
Equity Financing: In February 2018, the company completed an underwritten public offering in which it sold 6,325,000 shares of common stock, including the full exercise of the over-allotment of an additional 825,000 shares, to the public at a price of $8.00 per share. Net proceeds of the underwritten public offering, after deducting the underwriting discounts and commissions and financing costs, were $47.3 million.
Cash Position: Cash, cash equivalents and investments totaled $82.6 million as of December 31, 2017. This amount excludes payment of a $12.5 million milestone from AstraZeneca achieved in the fourth quarter of 2017, the $47.3 million in net proceeds from the February 2018 equity financing, and the $30.0 million upfront payment due from Seattle Genetics.
"2017 was a transformational year for Pieris, as we advanced our lead respiratory and IO drug candidates into the clinic, while advancing PRS-080 into a phase 2a study and entering into two major alliances, in respiratory diseases and IO, bringing increased validation to our R&D strategy while retaining commercial rights on several partnered programs and strengthening our cash position," said Stephen S. Yoder, President and CEO. "This momentum continued into 2018 as we signed a significant IO collaboration agreement with Seattle Genetics. We are developing three clinical-stage programs, data from all of which are projected to be available later this year. In addition, we continue to build long-term value by advancing multiple preclinical IO programs with the intention to file two new INDs in 2019, while engaging in a broad research effort developing novel Anticalin proteins against multiple targets in both IO and respiratory diseases. We look forward to sharing data across our pipeline later this year."

Fiscal Year Financial Update:

Cash Position – Cash, cash equivalents and investments totaled $82.6 million as of December 31, 2017, compared to a cash balance of $29.4 million as of December 31, 2016. The increase was driven primarily by a $45.0 million upfront payment received as part of the AstraZeneca respiratory alliance, a EUR30.0 million (approximately $32.0 million) upfront payment received from Servier, and a $2.8 million option payment received from ASKA. This was offset by $39.3 million of operating cash expenditures during the year.

R&D Expense – R&D expenses were $22.3 million for the year ended December 31, 2017, compared to $19.7 million for the year ended December 31, 2016. The Company’s increase in R&D expenses reflects advancement across its pipeline of programs as well as preparation for and advancement of clinical studies.

G&A Expense – G&A expenses for the year ended December 31, 2017 were $17.6 million, compared to $8.9 million for the year ended December 31, 2016. The increase in the 2017 period as compared to the corresponding period in 2016 is attributable in part to transaction fees associated with the company’s partnership agreements and investments in our G&A functions including personnel costs, recruiting costs, and professional services (audit, tax, legal and communications) to support the growing business.

Net Loss – Net loss was $17.6 million or $(0.40) per share for the year ended December 31, 2017, compared to a net loss $22.8 million or $(0.55) per share for the year ended December 31, 2016.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM Eastern Standard Time on Friday, March 9, 2018, to discuss the full year financial results and provide a corporate update. You can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

TRILLIUM THERAPEUTICS REPORTS ANNUAL 2017 FINANCIAL AND OPERATING RESULTS

On March 9, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the year ended December 31, 2017 (Press release, Trillium Therapeutics, MAR 9, 2018, View Source [SID1234524605]).

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"In 2017 we achieved a marked increase in patient enrollment in both our intravenous and intratumoral trials with TTI-621, which has allowed us to gain further insight into the safety and activity of this novel innate immune checkpoint inhibitor," said Dr. Niclas Stiernholm, President and CEO of Trillium Therapeutics. "We were especially gratified to see single-agent activity, as it may provide us with a relatively direct route to more advanced trials, while still having opportunities to pursue combination therapies in the future. In 2018 we plan to transition from signal-seeking mode to focusing on the most promising indications. We will also be introducing our second clinical CD47 program, TTI-622, leveraging the knowledge gained with TTI-621."

2017 Highlights:

Presented data at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showing locoregional tumor regression in 9/10 cutaneous T cell lymphoma patients receiving intratumoral TTI-621 monotherapy, often after a single injection.


Presented data at the 2017 ASH (Free ASH Whitepaper) Annual Meeting demonstrating that heavily pre- treated patients with relapsed/refractory diffuse large B cell lymphoma can achieve objective responses and/or prolonged progression-free intervals, following intravenous administration of TTI-621 either as monotherapy or in combination with rituximab.

ASH data indicate that TTI-621 is well tolerated by both routes of administration; notably, the transient thrombocytopenia observed after intravenous dosing was shown to be attenuated after the first dose.


Received a "Study May Proceed" letter from the FDA to enable a Phase 1a/b clinical trial of TTI-622 (SIRPa-IgG4 Fc) in cancer patients. This study will consist of a 3+3 intrapatient dose-escalation phase followed by an expansion phase with combination therapy cohorts.

Annual 2017 Financial Results

As of December 31, 2017, Trillium had cash and cash equivalents and marketable securities, and working capital of $81.8 million and $68.9 million, respectively, compared to $50.5 million and $45.5 million, respectively at December 31, 2016. The increase in cash and cash equivalents and marketable securities, and working capital was due mainly to the June and December 2017 financings raising net proceeds of $62.5 million partially offset by cash used in operations of approximately $27.0 million and an unrealized foreign exchange loss of $3.7 million.

Net loss for the year ended December 31, 2017 of $45.1 million was higher than the loss of $31.7 million for the year ended December 31, 2016. The net loss was higher due mainly to higher research and development expenses of $7.3 million in 2017 from two active TTI-621 phase I trials and manufacturing expenses for TTI-622, the recognition of a deferred tax recovery in the year ended December 31, 2016 related to the acquisition of Fluorinov of $3.7 million, and a higher net foreign currency loss of $2.7 million in 2017.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Puma Biotechnology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Puma Biotechnology, 2018, MAR 9, 2018, View Source [SID1234524630]).

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Proposed merger between Medical Prognosis Institute and Oncology Venture

On March 9, 2018 Medical Prognosis Institute A/S ("MPI") (Nasdaq First North Stockholm: MPI) and Oncology Venture Sweden AB (publ) ("Oncology Venture" or "OV") (AktieTorget: OV) reported that their respective Boards of Directors have agreed on a joint merger plan (the "Merger Plan") to accomplish a merger of the companies (the "Merger") (Press release, Oncology Venture, MAR 9, 2018, View Source [SID1234586757]). Combining these two highly complementary businesses will result in a leading integrated oncology biotechnology company with a promising anticancer drug pipeline (OV) resting on a proprietary patient screening technology to predict drug response (MPI’s DRP). The Merger will be implemented with MPI as the continuing legal entity and OV as the discontinuing entity. Following completion of the merger the combined company will be referred to as ‘Oncology Venture’. The Merger is conditional upon, inter alia, approvals at the extraordinary general meetings of both companies. Oncology Venture’s shareholders will receive as merger consideration 1.8524 shares in Medical Prognosis Institute for each share in OV. Above 50 percent of the shareholders in OV and above 70 percent of the shareholders in MPI, have undertaken or declared their intention to vote in favor of the Merger at their respective upcoming extraordinary general meetings.

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The Boards of Directors of Oncology Venture and MPI(1) have identified considerable strategic and operational rationales for a merger, based on the companies’ complementary business models, strong business relations and high degree of interdependence, as well as the significant overlaps in terms of ownership structures and executive management teams.

Creating a leading integrated company with unique competences and resources to identify and develop personalized cancer drugs

The proposed Merger has the potential to create a leading oncology biotechnology company that deploys MPI’s unique biomarker technology (DRP) with Oncology Venture’s capability of identifying and developing personalized cancer drugs.
The combined company will be well positioned to play a significant role in defining the cancer treatments of tomorrow, by providing opportunities for higher-speed drug development processes and better accuracy in drug relevance to patients.
With one company in full control of both the DRP technology and the drug candidates under development, transparency towards drug candidate licensees and licensors increases.
The Merger will build strength through increased scale and possible product diversification, enabling a more diversified revenue base.
Expected operational synergies amount to more than SEK 2 million per year. Savings that will be transferred into our core business of drug development.
Shareholdings between Oncology Venture and MPI

MPI holds 8.45 percent of the shares in Oncology Venture at the date of the announcement of the Merger. Furthermore, MPI holds warrants entitling MPI to subscribe for shares corresponding to approximately additionally 1.44 per cent of the shares in Oncology Venture. Oncology Venture does not hold or control any shares in MPI or any other financial instruments which gives Oncology Venture a financial exposure equivalent to a shareholding in MPI.

Summary of the transaction

The Boards of Directors are of the opinion that the combination of MPI and OV should be implemented by means of a statutory cross border merger in accordance with the EU Directive 2005/56/EC of 26 October 2005 as implemented in Danish and Swedish law, respectively, whereby the companies’ shareholders are given the opportunity to approve the merger at their respective extraordinary general meetings. The Boards of Directors propose that the Merger is implemented with MPI as the continuing legal entity and OV as the discontinuing entity. The plan is that the name of the merged company will be ‘Oncology Venture’.
The exchange rate of shares between the two companies has been calculated based on the 4 weeks trading volume-weighted average share price of the two companies, following the completion of the OV capital raise on 25 January 2018. No premium/discount is given to either company’s shareholders.
OV’s shareholders will receive as a merger consideration 1.8524 shares in MPI for each share in OV outstanding as at completion of the Merger. Hence, OV’s shareholders will receive approximately 51.3 percent economic ownership in the combined company.
Each holder of the warrants issued in existing warrant programs in OV have undertaken in relation to OV and MPI not to exercise the warrants and the warrants will hence be annulled in connection with the Merger. The holders of these warrants will subsequently be issued warrants in MPI with substantially the same terms and financial value as the existing warrants.
The current Board of Directors of MPI will continue until the first General Meeting of the merged company. The continuing Board of Directors is planned to consist of members from both of the current Boards of Directors.
The completion of the Merger is subject to, inter alia, approval by the shareholders of each of MPI and OV at their respective extraordinary general meetings, which are currently expected to be held in late May or early June 2018.
The formal decision to the proposed merger will be taken at an Extraordinary General Meeting (EGM) in each of the respective companies. The decision requires support from at least 2/3 of the shares present and votes cast at the EGM in order to be formally agreed upon.
Above 50 percent of shareholders in OV, including Sass & Larsen Aps, Buhl Krone Holding Aps, Seed Capital A/S and above 70 percent of shareholders in MPI, including MPI Holding Aps (fully owned by Steen Knudsen), Sass & Larsen Aps and Buhl Krone Holding Aps, have undertaken to vote in favor of the Merger at the respective upcoming extraordinary general meetings.
The combined company will continue to be listed on Nasdaq First North.

The Board of Directors of Oncology Venture considers the merger consideration to be fair from a financial point of view to its shareholders, and has obtained a fairness opinion from KPMG Transactional Advisors, dated as of March 8, 2018, reflecting their opinion as of that date that, on the basis of the considerations stated therein, the merger consideration to be paid by MPI is fair, from a financial point of view, to the shareholders in Oncology Venture.

The Board of Directors of MPI considers the merger consideration to be fair from a financial point of view to its shareholders and has obtained a valuation expert’s statement dated March 8, 2018 from EY Transaction Advisory reflecting their opinion as of that date that, on the basis of the considerations stated therein, the merger consideration to be paid by MPI is fair, from a financial point of view, to MPI.

Comments from Frank Knudsen, Chairman of the Board of Directors of MPI:

"I’m very happy about this opportunity to create a leading, integrated oncology biotech company with a promising anticancer drug pipeline developed by a proprietary Drug Response Predictor. I believe that by combining the assets and capabilities of MPI and Oncology Venture, we can bring new and improved cancer treatments to patients in a time- and cost-efficient way."

Comments from Duncan More, Chairman of the Board of Directors of Oncology Venture:

"Merging is the natural next step for both companies. I believe that by creating a ‘One Stop Shop’ the unified focus and savings will enable us to do more – faster. I also believe that the business model which includes both the DRP technology as well as anticancer drug development differentiates us from other companies and positions us as an attractive partner for developers – that is drug owners with cancer products that require our technology (DRP) to become clinically relevant – and customers that are drug companies with commercialization power. The approval of anticancer drugs for the treatment of tumors based on their molecular biology as opposed to their histopathology or location in the body is becoming a feature of the market. This is precisely the goal of the new combined company"

Comments from Peter Buhl Jensen, CEO of Oncology Venture and MPI:

"The Merger is a long time wish from several investors and the unity will be a valuable advantage in negotiations with drug owners, potential biotech and pharma partners and future acquirers of our drug candidates. The future of oncology drug development is increasingly integrating drugs and their companion diagnostics – we will be on the forefront of this development."

Comments from Steen Knudsen, CSO, inventor of the DRP technology and founder of MPI:

"I’m very supportive of merging the two companies as I believe that this will best facilitate a focused and fast route for putting the DRP to work for the benefit of cancer patients."

Overview of the combines company

Business overview

The combined company will be a leading Global oncology biotechnology company, with a clear focus as well as a modern vision of how the oncology market place is developing. The deployment of the unique biomarker technology that is the DRP technology to identify high likely responders for all the in-licensed pipeline products is expected to result in faster progress and more commercially viable products.

Due to the nature of biotechnology and the maturity of the combined company limited revenue generation is expected in the coming 12-18 months. Hence, the company will be dependent upon current liquidity reserves, and its ability to attract new liquidity.

The company currently holds liquidity reserves that allows the company to execute its current plans throughout 2018.

The company will undertake the necessary initiatives to ensure the needed funding is readily available end of 2018 for the company to fully realize its plans and exploit its opportunities.

Following the merger of MPI and OV it is the intention of the management of the combined company to bring the company to the Nasdaq main market in Stockholm.

Oncology Venture has been advised by Dragon Financial Partners.

Synergies and Integration

The Merger is expected to create substantial value for the shareholders of the combined company through synergies resulting from the coordination of the operations of the two companies and through the expansion of the combined company’s addressable business opportunities compared to MPI’s and OV’s standalone. In total, annual operating synergies are estimated to be in excess of SEK 2 million.

The synergies are expected to be realized with a short time horizon, and latest in year 2 following the Merger.

The integration of operations will commence immediately after the Merger is completed, and it is expected that the combined company will start to achieve synergies from the first year following the transaction completion. The integration is expected to be relatively smooth, given the overlapping management and key resources across the two companies.

Effects for employees

At completion of the Merger, the employees of Oncology Venture will – as a consequence of the Merger – automatically become employees of the combined company on terms and conditions equal to their existing employment terms and conditions. It is expected that all employment agreements will continue unaltered following the Merger and no redundancies are expected.

Ownership structure

Pursuant to the Merger Plan, OV’s shareholders will receive approximately 51.3 percent economic ownership in the combined company.

The illustrative table below shows the ownership of the combined company as if the Merger had been completed based on the latest available shareholding information.

Source: Company information

Following the Merger, the combined company will continue to be listed on Nasdaq First North Stockholm and be domiciled and headquartered in Hørsholm, Denmark.

Recommendation from the Board of Directors of MPI

The Board of Directors of MPI is of the opinion that the Merger is beneficial to MPI and its shareholders. The Board also considers the merger consideration to be fair from a financial point of view to MPI and has obtained a valuation expert’s statement dated March 8, 2018 issued by EY Transaction Advisory reflecting their opinion as of that date that, on the basis of the considerations therein, the merger consideration to be paid by MPI is fair, from a financial point of view, to MPI.

Recommendation from the Board of Directors of OV

The Board of Directors of OV is of the opinion that the Merger is beneficial to OV and its shareholders. The Board also considers the merger consideration to be fair, from a financial point of view, to the holders of OV shares and this view is supported by a fairness opinion from KPMG Valuation Advisors, acting as financial advisor to the Board of Directors of OV, dated as of March 8, 2018, to the effect that, as of such date and based upon and subject to the assumptions and limitations set forth therein, the merger consideration to be received in the merger by holders of OV shares is fair, from a financial point of view, to such holders. The Board of Directors of OV has issued a statement pursuant to Section II.19 of the Takeover rules for certain trading platforms adopted by the Swedish Corporate Governance Board (Sw. Takeover-regler for visa handelsplattformar som utfärdats av Kollegietför svensk bolagsstyrning) (the "Takeover Rules"), in which the shareholders of OV are recommended to vote in favor of the Merger.

Conditions for the Merger

Completion of the Merger is subject to the satisfaction of the following conditions prior to the general meetings of the respective companies voting on the merger proposal:

(i) the registration by Danish FSA of a merger prospectus;

(ii) passporting of the merger prospectus to Sweden in accordance with Article 25 of Regulation (EU) 2017/1129; and

(iii) no material adverse change affecting either of the companies shall have occurred or be pending or shall be threatening to occur.

The Board of Directors of each of the companies will only convene the general meetings of the respective company voting on the merger proposal if the conditions set out above are satisfied or waived, provided that this right will only be utilized to the extent permitted by applicable law, if the non-satisfaction is of material importance to the Merger or the combined company. The Board of Directors of the companies may waive the above conditions at their discretion.

In the event that the conditions stipulated in (i) – (iii) have not been satisfied by each company on or before September 30 2018 the Merger Plan will automatically terminate and cease to have any further force or effect.

Applicable law and disputes

The Merger shall be governed by and construed in accordance with the laws of Sweden. The Takeover Rules, the Swedish Securities Council’s (Sw. Aktiemarknadsnämnden) statements and advice on interpretation and application of the Takeover Rules and, if applicable, the Swedish Securities Council’s earlier statements and advice on interpretation and application of the Industry and Commerce Stock Exchange Committee’s (Sw. Näringslivets Börskommitté) rules for public offers as previously applicable, are applicable on the merger. The courts of Sweden shall have exclusive jurisdiction over any dispute arising out of or in connection with the Merger and the City Court of Stockholm shall be the court of first instance.

Tentative time schedule

The Merger Plan is announced and made available to the companies’ shareholders
April, 2018 Publication of the merger prospectus
May, 2018 Extraordinary general meetings in MPI and OV
August, 2018 The Swedish Companies Registrations Office registers the Merger
For further information, please contact:

About MPI
Medical Prognosis Institute is a publicly traded international company specialized in improving cancer patients’ lives by developing Personalized Medicine using its unique DRP technology. MPI’s exceptional opportunity to personalize cancer treatment begins with Breast Cancer moving on to Multiple Myeloma and Prostate Cancer as the first steps. MPI’s DRP tool has shown its ability to separate patients who benefit and who do not benefit from a specific cancer treatment. This has been shown in as many as 29 out of 37 trials, and covers more than 80 anti-cancer treatments in a wide range of cancer indications. MPI has built a significant large database with over 1,400 screened breast cancer patients and is building up a database in Multiple Myeloma to be followed by Prostate cancer in collaboration with oncologists and hematologists throughout Denmark. MPI has ownership of Oncology Venture (Publ) a spinout with three anti-cancer drugs in pipeline entered and of the privately hold Special Purpose Vehicles, 2X Oncology Inc. and OV-SPV2 Aps with four products in pipeline.

Asterias Biotherapeutics to Report Fourth Quarter and Full Year 2017 Results on March 15, 2018

On march 9, 2018 Asterias Biotherapeutics, Inc. (NYSE American:ST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, reported that it will release fourth quarter and full year 2017 financial and operating results on Thursday, March 15, 2018 after the close of the U.S. financial markets (Press release, BioTime, MAR 9, 2018, View Source;p=RssLanding&cat=news&id=2337278 [SID1234524609]). The Company will host a conference call and webcast on March 15, 2018 at 5:00 p.m. ET / 2:00 p.m. PT to discuss the results and corporate developments.

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For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 888-503-8163. For international participants outside the U.S./Canada, the dial-in number is 719-325-4857. For all callers, refer to Conference ID 9547064. To access the live webcast, go to View Source

A replay of the conference call will be available for one month beginning about two hours after the conclusion of the live call, by calling toll-free (from U.S./Canada) 888-203-1112; international callers dial 719-457-0820. Use the Conference ID 9547064. Additionally, the archived webcast will be available at View Source

About Asterias Biotherapeutics