On March 12, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology, and immunology, reported financial results for the fourth quarter and year ended December 31, 2017 and provided an update on its clinical development and commercial programs (Press release, Aclaris Therapeutics, MAR 12, 2018, View Source [SID1234524664]).

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"2017 was a defining year in Aclaris’ history, with the FDA approval of ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w), the first and only FDA-approved topical, non-invasive treatment of raised seborrheic keratosis (SK). We have generated a high level of excitement around ESKATA in the dermatology community, and look forward to our official launch in the second quarter of 2018," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. "In January 2018, we announced positive topline results from two Phase 2 clinical trials (WART-202 and WART-203) of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts (verruca vulgaris). We also advanced our topical Janus kinase (JAK) inhibitor programs in alopecia, with results from multiple Phase 2 trials expected later this year. As our early-stage pipeline compounds advance towards the clinic, we continue to progress towards our goal of becoming a vertically integrated, commercial-stage biopharmaceutical company with a robust clinical-stage pipeline and drug discovery engine."

Clinical Pipeline Update

A-101 45% Topical Solution

oIn January 2018, reported positive results from two Phase 2 clinical trials (WART-202 and WART-203) of A-101 45%, an investigational new drug for the treatment of common warts. A-101 45% met all primary, secondary, and exploratory endpoints of each trial analyzed to date, achieving clinically and statistically significant clearance of common warts.

Scheduled an End of Phase 2 meeting with the FDA for mid-2018, and plan to initiate two pivotal Phase 3 trials in the second half of 2018.

·JAK Inhibitor

oAA-202 Topical – an ongoing Phase 2 clinical trial of ATI-502 (formerly ATI-50002) for the topical treatment of alopecia areata (AA). This trial will evaluate the pharmacokinetics,

pharmacodynamics and safety of ATI-502 compared with placebo in 12 patients with AA. This randomized, double-blind clinical trial is being conducted at two investigational centers within the United States, and topline data are expected in the first half of 2018. After completing the 28-day portion of the trial, patients will then enter a 6-month open label extension during which all patients will receive drug.

AUATB-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of AA. This trial will evaluate the effect of ATI-502 on the regrowth of eyebrows in up to 24 patients with AA. This trial is being conducted at two investigational centers in Sydney and Melbourne, Australia, and topline qualitative data are expected mid-2018.

AA-201 Topical – an ongoing Phase 2 dose ranging trial of ATI-502 for the topical treatment of AA. This trial will evaluate the effect of two concentrations of ATI-502 on the regrowth of hair in a randomized, double-blinded, parallel-group, vehicle-controlled trial in up to 120 patients with AA. This trial is being conducted at 25 investigational centers within the United States and data are expected by year end 2018.

VITI-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of vitiligo. This trial will evaluate the effect of ATI-502 on the repigmentation of facial skin in up to 24 patients with vitiligo and data are expected in the first half of 2019.

oAGA-201 Topical – a planned Phase 2 open-label clinical trial of ATI-502 for the topical treatment of androgenetic alopecia (AGA), also known as male/female pattern hair loss, which is anticipated to begin in the first half of this year. This trial will evaluate the effect of ATI-502 on the regrowth of hair in up to 24 patients with AGA and data are expected in first half of 2019.

AUAT-201 Oral – a planned Phase 2 dose ranging trial of ATI-501 (formerly ATI-50001), an oral JAK inhibitor, for the treatment of AA which is anticipated to begin in the first half of 2018. Data are expected in mid-2019.

ATI-450

Recently presented data from pre-clinical studies of ATI-450 (formerly known as CDD-450), a selective inhibitor of the MK2 pathway, at a symposium at the American College of Rheumatology annual meeting on November 7, 2017. The abstract summarizing the data is titled "NOMID-Associated Complications in Mice Are Prevented By CDD-450, a Small Molecule Inhibitor of the Mitogen-Activated Protein Kinase-Activated Protein Kinase 2 (MK2) Pathway."

Investigational New Drug application on track for submission to the FDA in mid-2019.

Commercial Update

Expanded commercial organization to 70 people in support of a successful ESKATA launch.

Established Aclaris Market Research, Sales, Trade, Training, and Sales Operations teams.

oSuccessfully onboarded and trained Aclaris sales force consisting of 50 Field Sales Specialists, 2 Inside Sales Representatives, 6 Regional Sales Managers, and 1 Sales Director.

Conducted market research with over 2,500 patients and 1,400 HCPs to date.

Developed comprehensive HCP and consumer campaigns to support a successful ESKATA launch.

Finalized ESKATA pricing and positioning

Established ESKATA speaker bureau consisting of dermatologist and NP/PA speakers.

Aclaris present at 30 key dermatology meetings in 2017.

Generated a high level of corporate awareness with the goal to position Aclaris as a leading innovative biopharmaceutical company in dermatology.

Raised awareness regarding SK disease state awareness and patient willingness to pay for SK removal.

Strong presence at 2018 Winter AAD in San Diego; Generated a high level of ESKATA awareness.

Sales force currently implementing key market readiness activities, including:

Establishing ESKATA Centers of Excellence.

Implementation of ESKATA Early Experience Initiative.

National Sales Meeting scheduled for the second quarter of 2018, followed by official ESKATA launch.

Recent Corporate Highlights

Promoted Brett Fair to Chief Commercial Officer

Continued to build our research and development and commercial infrastructure.

The United States Patent and Trademark Office recently issued U.S. Patent No. 9,895,301, which is directed to methods related to the use and administration of a certain JAK inhibitor for treating hair loss disorders.

U.S. Patent No. 9,895,301 covers the use of tofacitinib for inducing hair growth and for treating hair loss disorders such as alopecia areata and AGA. Additional issued claims pertain to methods of using tofacitinib to treat particular phenotypes of alopecia areata, as well as to treat other hair loss disorders. The ‘301 Patent contains 67 claims and expires in November 2031.

This newly allowed patent is owned by The Trustees of Columbia University in the City of New York and exclusively licensed to Aclaris and is the latest U.S. patent to issue in connection with Aclaris’ JAK drug development program for hair loss disorders.

Recently added to the NASDAQ Biotechnology Index (NASDAQ: NBI).

Financial Highlights

Liquidity and Capital Resources

As of December 31, 2017, Aclaris had aggregate cash, cash equivalents and marketable securities of $208.9 million compared to $174.1 million as of December 31, 2016. The $34.8 million increase during the year ended December 31, 2017 included:

Aggregate net proceeds of $100.2 million from the sale of common stock under an at-the-market facility with Cowen and Company LLC in April 2017 and a follow-on public offering of common stock in August 2017.

$9.6 million of cash used to acquire Confluence in August 2017, net of cash acquired.

$1.2 million of purchases of property and equipment.

Net loss of $68.5 million, offset by $0.9 million of net cash provided by working capital and $14.8 million of non-cash stock-based compensation expense, depreciation and amortization.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2017 will be sufficient to fund its operations into the second half of 2019, without giving effect to any potential new business development transactions or financing activities.

Fourth Quarter 2017 Financial Results

Net loss was $22.9 million for the fourth quarter of 2017, compared to $11.5 million for the fourth quarter of 2016. Upon new tax legislation passed in December 2017, Aclaris recognized an income tax benefit of $1.8 million related to the reversal of the deferred tax liability associated with the In-Process Research and Development recognized in the Confluence acquisition earlier this year.

Revenue of $1 million and cost of revenue of $0.8 million for the fourth quarter of 2017 related to our contract research business acquired in August 2017.

Total operating expenses for the fourth quarter of 2017 were $25.7 million, compared to $11.6 million for the fourth quarter of 2016.

Research and development expenses were $13.2 million for the fourth quarter of 2017, compared to $6.9 million for the fourth quarter of 2016. The increase of $6.3 million was primarily attributable to a $2.3 million increase in expenses related to the WART-202 andWART-203 trials, a $1.5 million increase in personnel-related expenses, including stock-based compensation, due to increased headcount, a $2 million increase in preclinical and clinical trial development expenses related to the JAK inhibitor portfolio and a $1.5 million increase in Medical Affairs expenses and other costs, including early stage drug discovery. This increase was partially offset by a $1.3 million decrease due to the completion of our ESKATA Phase 3 clinical trials and the submission preparation of the NDA for ESKATA in November 2016.

General and administrative expenses were $12.5 million for the fourth quarter of 2017, compared to $4.7 million for the fourth quarter of 2016. The increase of $7.8 million was primarily attributable to $2.9 million in higher personnel-related expenses, including stock-based compensation, due to increased headcount, and a $1 million increase related to relocating our corporate headquarters and administrative costs related to our St. Louis, Missouri operations acquired in August 2017. Additionally, Aclaris incurred a $3.3 million increase in market research and sales operations expenses related to pre-commercial activities for ESKATA.

Full Year 2017 Financial Results

Net loss was $68.5 million for the year ended December 31, 2017, compared to $48.1 million for the year ended December 31, 2016.

Revenue of $1.7 million and cost of revenue of $1.2 million for the year ended December 31, 2017 related to the contract research business acquired in August 2017.

Total operating expenses were $72.9 million for the year ended December 31, 2017, compared to $48.6 million for the year ended December 31, 2016. Net cash used in operating activities was $54.7 million, compared to $34.6 million for the year ended December 31, 2016.

Research and development expenses were $39.8 million for the year ended December 31, 2017, compared to $33.5 million for the year ended December 31, 2016. The increase of $6.3 million was due to higher payroll-related expenses of $5.6 million due to increased headcount, including stock-based compensation expense, an increase of $4.5 million in preclinical and clinical trial development expenses related to our JAK inhibitor portfolio, an increase of $3.4 million in expenses related to the WART-202 and WART-203 trials, and a $3.6 million increase in medical affairs and early stage drug discovery activities. The increases noted above were partially offset by a $7.7 million decrease related to our ESKATA Phase 3 clinical trials costs, which were completed in November 2016, and $3.4 million in costs incurred with the acquisition of Vixen Pharmaceuticals, Inc. in the year ended December 31, 2016.

General and administrative expenses were $33.1 million for the year ended December 31, 2017, compared to $15.1 million for the year ended December 31, 2016. The increase of $18million was primarily attributable to an increase of $9.3 million in payroll-related expenses due to increased headcount, including stock-based compensation expense, an increase of $6.1 million in pre-commercial launch activities for ESKATA, a $1.3 million increase in facilities-related costs, and a $1.3 million increase in other professional fees.

As of December 31, 2017, Aclaris had approximately 30.8 million shares of common stock outstanding.

2018 Financial Outlook

Aclaris expects 2018 GAAP research and development (R&D) expenses to be in the range of $67 to $75 million, which, when excluding estimated stock-based compensation of $9 million, results in 2018 non-GAAP R&D expense of $59 to $67 million. The anticipated increase in R&D expenses in 2018 is mainly due to the planned execution of Phase 2 clinical trials in AA, AGA, and vitiligo, two planned pivotal Phase 3 trials in common warts, and development of our early stage pipeline compounds.

Aclaris expects 2018 GAAP selling, general and administrative (SG&A) expenses to be in the range of $80 to $86 million, which, when excluding estimated stock-based compensation of $14 million, results in 2018 non-GAAP SG&A expense of $66 to $72 million. The anticipated increase in SG&A expenses in 2018 is primarily the result of the deployment of our new salesforce in January 2018 and the additional selling, marketing and consumer initiatives to support the commercial launch of ESKATA.

·Company to Host Conference Call

Management will conduct a conference call at 8:00 a.m. ET today to discuss Aclaris’ financial results and provide a general business update. The conference will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 1495576 prior to the start of the call.

On March 12, 2018 Merrimack Pharmaceuticals Inc. saw a slight uptick in pre-market trading this morning after the company reported it is expanding enrollment in a Phase II lung cancer study (Press release, BioSpace, MAR 11, 2018, View Source [SID1234524670]).

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Cambridge, Mass.-based Merrimack said it has seen a "tremendous interest" in its open-label Phase II SHERLOC study assessing progression-free survival in patients who have received MM-121 in combination with docetaxel. The trial is comparing the combination treatment with docetaxel as a stand-alone therapy in patients with heregulin-positive non-small cell lung cancer who have progressed after a platinum-containing regimen.

In its announcement, Merrimack said it will expand trial enrollment from 80 patients to 100. The trial patients must have received a prior platinum-based therapy, as well as prior immunotherapy where available and clinically indicated, the company said.

The trial expansion followed a year in which Merrimack reset its focus on its 10 wholly-owned clinical and preclinical programs that target biomarker-defined cancers. Merrimack began its internally-developed focus in early January after the company sold some assets, including FDA-approved pancreatic cancer treatment Onivde to Ipsen for $575 million. That placed the company’s futures on its wholly-owned assets, including MM-121.

Investors have not been too happy with Merrimack since the Ipsen deal. Over the course of 2017, the company saw its share prices drop by 63 percent. Shares of Merrimack closed at $11.58 on March 9.

Merrimack’s MM-121 (seribantumab) is a fully human anti-HER3 (ErbB3) monoclonal antibody. The drug is designed to target phenotypically distinct heregulin positive cancer cells within solid tumors. Typically heregulin positive cancer cells have been able to "escape the effects" of targeted, cytotoxic and anti-endocrine therapies, Merrimack said. That ability provides the potential for the rapid progression of the disease. When MM-121 is used in combination with the chemotherapy drug docetaxel, the company believes the dual treatment will block the heregulin/HER3 signaling axis, which will make tumor cells more sensitive to the effects of the combination therapy.

In October 2017 the U.S. Food and Drug Administration granted orphan drug designation to MM-121 in this setting. The orphan drug designation is granted to drugs that are being developed to treat a patient population of fewer than 200,000 people in the United States.

Sergio Santillana, Merrimack’s chief medical officer, said enrollment in the SHERLOC study has been faster than the company expected. Calling that an encouraging sign, Santillana said the interest reflects what the company believes is "the significant unmet medical need among this patient population."

"This expansion enables us to maximize this opportunity to gain meaningful insight, by strengthening the statistical design of the study, and emerge with a clear path forward," Santillana said in a statement.

Even with the additional patients added to the trial, Merrimack said it anticipates rolling out top-line data for the study in the second half of 2018.

In addition to heregulin-positive non-small cell lung cancer, Merrimack is also testing MM-121 in patients with heregulin-positive, hormone receptor-positive and HER2-negative post-menopausal metastatic breast cancer. In February the company dosed its first patient in a randomized Phase II trial. The mid-stage study, called SHERBOC, is testing the combination of MM-121 with chemotherapy treatment fulvestrant against placebo.

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.

Insys Therapeutics 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, Insys Therapeutics, 2018, MAR 9, 2018, View Source [SID1234524716]).

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Exicure 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, Exicure, 2018, MAR 9, 2018, View Source [SID1234524663]).

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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!