Critical Outcome Technologies Applies for Orphan Drug Designation for COTI-2 Treatment of Ovarian Cancer

Orphan Drug Designation Could Serve Unmet Medical Need and Provide Significant Financial Benefits LONDON, ONTARIO--(Marketwired - April 4, 2014) - Critical Outcome Technologies Inc. ("COTI" or the "Company") (TSX VENTURE:COT), the bioinformatics and accelerated drug discovery company, announced today it has submitted an Orphan Drug Application to the U.S. Food and Drug Administration (FDA) for its lead cancer drug candidate, COTI-2, for the treatment of ovarian cancer.

"We believe that COTI-2, with its p53 dependent mechanism of action, represents a significant therapeutic advantage over treatments currently available for ovarian and other gynecological cancers," said Dr. Wayne Danter, President and CEO. "The fact that more than 95% of ovarian cancers have a p53 gene mutation, combined with the extent of the unmet medical need in ovarian cancer patients, makes a treatment for this indication one of our top priorities. If COTI-2 is granted Orphan Drug status, the financial benefits in the future could be substantial and COTI-2 would be directed down a unique development pathway within the FDA, including the possibility of an expedited regulatory process and the potential for fewer patients to be required in clinical trials."

The Orphan Drug Designation may qualify the Company for several benefits under the U.S. Orphan Drug Act of 1983 (ODA), as amended. These benefits may include a seven-year period of orphan drug exclusivity upon product approval, fee reductions, assistance in study design from the FDA, potential for expedited drug development and eligibility for drug grants.

About Orphan Drug Designation Under the Orphan Drug Act, the FDA may grant the Orphan Drug Designation to facilitate drug development for drugs that target conditions affecting fewer than 200,000 patients in the United States each year, while providing a significant therapeutic advantage over existing therapies. The first new drug application to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for that product, for that indication.

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Dalton Pharma Services Announces Completion of a Major Expansion in Aseptic Filling Capabilities

Toronto, Ontario March 20, 2014 Dalton Pharma Services, a privately owned pharmaceutical services provider to leading pharmaceutical and biotechnology companies, today announces the completion of a $2.5 million expansion of its sterile and aseptic filling capabilities. This project included addition of sterile vial processing and washing, expanded vial depyrogenation capability, automated vial inspection capability, new Water For Injection (WFI) system, and expanded and improved gowning areas for GMP manufacturing operators.

"This is an important step in our strategic plan for increasing sterile filling capabilities at Dalton,” said Peter Pekos, President and CEO. “I am grateful for the hard work of our senior management and our key contractors that enabled completion of this key phase on schedule.”

“Besides increasing our overall capacity,” he added. “This expansion will allow us to provide our clients with more complete and efficient manufacturing services. The focus of future stages of the expansion will be the addition of high value capabilities supporting large and small molecule manufacturing development. The next stage of expansion is scheduled to begin later this year. Our overall goal continues to be the offering of fully integrated sterile manufacturing services from preclinical to commercial production, for both API and finished doses.”

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Sernova Announces Annual Meeting, Record Date and Adopts Advance Notice By-Law

FOR RELEASE February 26th, 2014, 6:00 a.m. EST LONDON, ONTARIO--(Marketwire – February 26th, 2014) - Sernova Corp. (TSX-V: SVA), a clinical stage company developing medical technologies for the long-term treatment of chronic debilitating metabolic diseases including diabetes and haemophilia is pleased to announce that it will hold an annual general and special meeting of shareholders (the “AGM”) on April 28, 2014. The record date for shareholders entitled to vote at the AGM is March 24, 2014. The Company also announces that the board of directors of the Company (the “Board”) has approved and adopted By-Law No. 3 of the Company, being a by-law relating to the nomination of directors of the Company (the “Advance Notice By-Law) which requires that advance notice be provided to the Company in circumstances where nominations of persons for election to the Board are made by shareholders of the Company other than pursuant to: (i) a requisition of a meeting of shareholders made pursuant to the provisions of the Canada Business Corporations Act; or (ii) a shareholder proposal made pursuant to the provisions of such Act. “We feel the Advance Notice By-Law is an important corporate governance tool that will ensure Sernova’s shareholders are treated fairly in being provided advanced notice of information in connection with the nomination of directors,” said Dr. Philip Toleikis, President and CEO. The Advance Notice By-law is similar to the advance notice by-laws adopted by many other Canadian public companies. The purpose is to foster a variety of interests of the shareholders and the Company by ensuring that all shareholders, including those participating in a meeting by proxy rather than in person, receive adequate notice of the nominations to be considered at a meeting and can thereby exercise their voting rights in an informed manner. In addition, the Advance Notice By-Law should assist in facilitating an orderly and efficient meeting process, provides shareholders, directors and management of the Company with a clear framework for nominating directors. Among other things, the Advance Notice by-Law fixes a deadline by which shareholders must submit director nominations to the Company prior to any meeting of shareholders and sets forth the minimum information that a shareholder must include in the notice to the Company for the notice to be in proper written form.

In the case of an annual meeting of shareholders, notice to the Company must be made not less than 30 nor more than 65 days prior to the date of the annual meeting; provided, however that in the event the annual meeting is to be held on a date that is less than 40 days after the date on which the first public announcement of the date of the annual meeting was made, notice may be made not later than the close of business on the 10th day following such public announcement.

In the case of a special meeting of shareholders (which is not also an annual meeting), notice to the Company must be made not later than the close of business on the 15th day following the day on which the first public announcement of the date of the special meeting was made.

The Advance Notice By-Law has been approved and adopted by the Board and is effective immediately. Shareholders will be asked to ratify and confirm the Advanced Notice By-Law at the AGM. A copy of the By-Law Amendments will be provided in the Management Information Circular, which will be filed under the Company’s profile at www.sedar.com.

For purposes of the AGM, in accordance with the terms of the Advance Notice By-Law, notice of nominations of persons for election to the Board at the AGM must be made by March 28, 2014 and be sent to the following email address of the Chief Executive Officer of the Company: Philip.toleikis@sernova.com.

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Debiopharm Group™ to Acquire Affinium’s Antibiotic Clinical Assets and Platform to Identify and Develop Targeted Antibiotics

Lausanne, Switzerland and Toronto, Ontario, February 11, 2014 — Debiopharm Group™ (Debiopharm), a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs as well as companion diagnostics, and Affinium Pharmaceuticals (Affinium), a Canadian company focusing on the development of a platform of novel, targeted narrow-spectrum antibacterial therapeutics, today announced the acquisition by Debiopharm of Affinium's clinical and preclinical assets as well as its technology platform. The clinical assets include AFN-1252, a FabI inhibitor designated by the FDA as a Qualified Infectious Disease Product (QIDP) which has successfully completed a Phase 2a study for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and, its prodrug AFN-1720, currently in Phase 1 clinical development. Both compounds are highly potent agents that are selectively active against all Staphylococcus species and strains tested thus far (5400 strains) including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA). In clinical trials, AFN-1252 has demonstrated an excellent efficacy, safety and tolerability profile in over 250 subjects. The possibility to treat staphylococcal infections with a molecule that allows for an intravenous-oral switch will be a major advance to address difficult-to-treat infections. Through its expertise of molecular diagnostics, Debiopharm will develop concomitantly with the clinical trials a diagnostic test that will allow to select Staphylococcus-infected patients, and increase the success of treatment.

"This acquisition is a strategic choice for Debiopharm and represents a massive continuing investment in antibiotic development. In September 2013, we entered the antibiotics arena by signing an agreement with TCG Life Sciences Ltd (India) to develop a novel class of antibiotics," said Thierry Mauvernay, Delegate of the Board of Debiopharm Group. "In 2013, the scientific community has shown that the gut microbiome plays vital roles in determining how the body responds to challenges as different as malnutrition, autoimmune diseases and cancer. Thus, as highlighted in the 2013 Science Breakthrough of the Year, we are convinced that it is crucial to develop innovative targeted antibiotics which preserve indigenous gut microbiota and overcome resistance to broad-spectrum antibiotics. Debiopharm intends to make additional investments in this promising field and become a key player in this therapeutic area and associated diagnostics".

"The purchase of Affinium's assets is a unique opportunity to develop a targeted antibiotic having demonstrated excellent efficacy and safety in clinical trials as well as the potential to preserve gut flora diversity and thus to prevent acquired resistance. We are very happy about this achievement and are confident that Affinium's novel platform will yield additional, new, first-in-class antibiotics in the near future," commented Andres McAllister, Chief Scientific Officer, Debiopharm International SA.

"We are delighted to transfer the subsequent development of Affinium's clinical lead antibiotic, AFN-1720, as well as the promising platform in selective antibiotics, to our colleagues at Debiopharm, stated Ed Mascioli, MD, CEO of Affinium. "We wish them every success in bringing AFN-1720 through regulatory approvals to serve the serious medical needs of an increasing patient population suffering from life-threatening Staphylococcal infections. We look forward to Debiopharm's unlocking the very promising potential of the platform in generating more specific, targeted antibiotics against other serious infectious pathogens. We are also very pleased that Drs. Nachum Kaplan and Barry Hafkin will continue with the program’s development. Their collective decades of expertise in microbiology and infectious diseases as well as with this program will ensure its future success."

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Frank Holler Joins Sernova’s Board of Directors

Experienced Biotech Entrepreneur and Investor to Bring Strategic Growth Expertise to Sernova Source: Sernova Corp FOR RELEASE February 11th, 2014, 6:00 a.m. EST LONDON, ONTARIO--(Marketwire – February 11th, 2014) - Sernova Corp. (TSX-V: SVA), a clinical stage company developing medical technologies for the long-term treatment of chronic debilitating metabolic diseases including diabetes, blood disorders such as haemophilia and other diseases, today announced the appointment of Mr. Frank Holler to its Board of Directors. A Vancouver-based entrepreneur and investor, Holler brings 25 years of success-driven experience in the biopharma and technology sectors to Sernova’s board. He has been directly involved in the founding and development of some of Canada’s most successful biopharma companies including ID Biomedical, Angiotech Pharmaceuticals and Xenon Pharmaceuticals.

“Frank possesses the ideal combination of coveted bio-science experience and strategic relationships with institutions and pharma to guide Sernova’s strategic advancement,” stated Dr. George Adams, Sernova’s Board Chair.

“I am pleased to be joining the board of Sernova,” said Mr. Holler. “Sernova’s CEO, Dr. Philip Toleikis is a former Angiotech colleague and I am looking forward to working with him and the Sernova team as we advance Sernova’s therapeutic cell-based product development programs and drive value for shareholders.”

Mr. Holler previously served as President & CEO of Xenon Pharmaceuticals, Inc., a genetics-based drug development company focused on the treatment of rare inherited medical conditions, President & CEO of ID Biomedical Corporation, a vaccine development company sold to GlaxoSmithKline in 2005, and was a founding director of Angiotech Pharmaceuticals, a TSX/NASDAQ-listed biotechnology company. He was also an investment banker with Merrill Lynch Canada and Wood Gundy, Inc. (now CIBC World Markets) and former director of the British Columbia Biotechnology Association (now LifeSciences BC), and in 2003 received the BC Biotech Award for Vision and Leadership. “Frank’s extensive industry experience, capital markets expertise and strategic insights will be very helpful as Sernova continues to advance its programs,” said Dr. Philip Toleikis, President and CEO of Sernova. “In particular, I believe his background in corporate finance, strategic partnering and M&A will be a good fit for Sernova as we continue to build out the Company’s leading position in regenerative medicine.”

Sernova also announces that it has granted an aggregate of 150,000 incentive stock options on February 11, 2014 to certain directors of the Company to purchase common shares in the capital stock of the Company subject to approval of the TSX Venture Exchange. Each option entitles the holder to purchase one common share of the Company at an exercise price of $0.15, for a period of 5 years, in accordance with the provisions of the Sernova Stock Option Plan.

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Sernova Announces Appointment of Cathy Steiner as CFO

Source: Sernova Corp FOR RELEASE January 31st, 2014, 6:00 a.m. EST LONDON, ONTARIO--(Marketwire – Jan. 31st, 2014) - Sernova Corp. (TSX-V: SVA), today announced that Ms. Cathy R. Steiner, CPA CA MSc MBA has joined the Company as Chief Financial Officer. Ms. Steiner is an industry veteran with over 20 years of experience working with healthcare companies as an investment banker, financial and capital markets advisor, and management consultant. Prior to joining Sernova, Ms. Steiner was Managing Director of Nucleus GC, an advisory services boutique specializing in the healthcare and life sciences sector. In this capacity, she advised healthcare clients at all stages of development on financings, mergers and acquisitions, business development, and growth strategy.

Previously she held the positions of Executive Director, Healthcare Investment Banking for CIBC World Markets, and Vice President, Healthcare Investment Banking for Yorkton Securities, where she was instrumental in raising over $1 billion in funding for Canadian-based companies, and in mergers and acquisitions worth in excess of $2 billion. Earlier, Ms. Steiner was Senior Tax Specialist at Deloitte.

“We are delighted to be bringing Cathy on board as Sernova’s CFO,” stated Dr. Philip Toleikis, President and CEO of Sernova. “Given her deep capital markets expertise as well as her extensive experience planning and closing successful transactions for healthcare companies, we are confident that she will make a great contribution to strengthening our financial position and advancing our corporate development.”

Sernova wishes to thank Mr. Bill Smethurst, the outgoing CFO, for his service to the Company.

Sernova also announces that it has granted an aggregate of 2,910,000 incentive stock options on January 27th, 2014 to certain directors, officers, employees and consultants of the Company to purchase common shares in the capital stock of the Company subject to approval of the TSX Venture Exchange. Each option entitles the holder to purchase one common share of the Company at an exercise price of $0.15, for a period of 5 years, in accordance with the provisions of the Sernova Stock Option Plan.

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Stem Cell Therapeutics Completes $33 Million Private Placement

Toronto, Canada – December 13, 2013 – Stem Cell Therapeutics Corp. (TSX-V: SSS; OTCQX: SCTPF), an immuno-oncology company developing cancer stem cell-related therapeutics, is pleased to announce that it has raised gross proceeds of $33 million through a private placement of units. The financing proceeds will be used to advance the Company’s CD47 cancer stem cell program through IND-enabling studies, manufacturing and phase 1 clinical trials. “The transformation of Stem Cell Therapeutics into a global competitor in the immuno-oncology space requires a value-driving asset backed by world class science, access to significant capital, experienced leadership, as well as a strong and knowledgeable investor base. As of today we have all those components,” commented the company’s CEO, Dr. Niclas Stiernholm.

The financing was led by a prominent U.S. healthcare fund, with participation from several other premier U.S. healthcare institutional investors, including Special Situations Funds, Ridgeback Capital, Merlin Nexus, Sabby Capital, venBio, Opaleye Management and HSMR Advisors. Bloom Burton & Co. acted as lead agent for the private placement. ROTH Capital Partners, LLC acted as placement agent in the United States.

“The significant investment and validating sponsorship from these reputable life science-focused funds is the result of a concentrated effort to introduce the U.S. investment community to our CD47 immune checkpoint program since the acquisition of Trillium Therapeutics in April 2013,” added Dr. Stiernholm.

In connection with the offering, the Company issued 157,142,858 units at a price of $0.21 each. The units consisted of either one common share and three-quarters of a common share purchase warrant (“Common Share Units”) or one Series 1 Non-Voting First Preferred Share and three-quarters of a common share purchase warrant (“Preferred Share Unit”). Of the total Units issued, 79,247,693 units were Common Share Units and 77,895,165 units were Preferred Shares Units. Each whole warrant entitles the holder to purchase one common share at a price of $0.28 at any time prior to expiry on December 13, 2018. Following the offering, the Company has 121,752,380 common shares issued and outstanding (144,031,618 on a fully diluted basis).

The Company paid its agents a commission of 6% of the gross proceeds of the offering (excluding subscription proceeds from certain President’s list subscribers), or $1,053,116, and issued a number of compensation warrants equal to 6% of the units sold in the offering (except units sold to President’s list subscribers), or 5,014,839 compensation warrants. Each compensation warrant entitles the holder to acquire one common share at an exercise price of $0.21 prior to expiry on December 13, 2015.

All securities issued under the offering (including the compensation warrants), in Canada are subject to a four month hold and resale restrictions under Canadian securities law, and in the United States are subject to statutory resale restrictions under U.S. securities laws. All securities issued under the offering are also subject to a four month hold imposed under the policies of the TSX Venture Exchange.

Subscribers who purchased Preferred Share Units and certain subscribers who purchased Common Share Units also agreed to be subject to restrictions on the conversion and exercise of securities of the Company convertible in common shares. Such subscribers cannot convert or exercise securities of the Company convertible into common shares if, after giving effect to the exercise of conversion, the subscriber and its joint actors would have beneficial ownership or direction or control over common shares in excess of 4.99% of the then outstanding common shares. This limit can be raised at the option of the subscriber on 61 days prior written notice: (i) up to 9.99%, (ii) up to 19.99%, subject to stock exchange clearance of a personal information form submitted by the subscriber, and (iii) above 19.99%, subject to stock exchange approval and shareholder approval.

Subject to receipt of any required regulatory approvals, subscribers who purchased a minimum of 10% of the securities sold under the offering have been given rights to purchase securities of the Company in future financings to enable each such subscriber to maintain its percentage holding in the Company for so long as the subscriber holds at least 10% of the outstanding common shares on a fully-diluted basis.

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Sernova Corp Engages Carson Seabolt and Network IR

November 27, 2013, 6:00 a.m. EDT LONDON, ONTARIO (Marketwire – November 27, 2013) - Sernova Corp (TSX-V: SVA), today is pleased to announce it has engaged Carson Seabolt and Network IR (“Network”) to develop and execute a comprehensive investor communications program to raise awareness of the Company within North American and International investment communities.

“Carson Seabolt and his team at Network IR are well-respected and will assist in the capital and institutional markets as we approach important Company milestones including anticipated clinical trial results in 2014,” said Dr. Philip Toleikis, Sernova Corp Chief Executive Officer.

“Our team is very excited to begin working with Sernova and its Management. It is a very rare opportunity to find a clinical-stage company that is working towards building such a worthwhile and potentially game-changing portfolio of products. I feel strongly that Dr. Toleikis and the entire Sernova team have the ability to deliver to the market, future patients and society a better way of treating what were once considered lifelong illnesses,” said Andrew Mugridge of Network IR.

“There is a lot to like about Sernova at this exciting juncture, and CEO Philip Toleikis is committed to ensure Sernova’s story is told to an ever-discerning retail audience. Attracting Carson Seabolt and NIR is a testament to Dr. Toleikis’s intuitive understanding that capital markets require an engaging, supportive retail ecosystem in the fruition of great projects. I credit Philip’s commitment to his stakeholders as we march into a promising 2014,”said Ray Matthews, Strategic Advisor.

Under the terms of the Company's agreement with Network IR, the Company will pay to Network a cash fee of $6,000 per month for six months and grant to Network a total of 300,000 incentive stock options, each option being exercisable, once vested, into one common share of the Company at a purchase price of $0.15 per share. The options shall vest in four equal quarterly installments, and will be governed by the Company's option plan and the policies of the TSX Venture Exchange.

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Sernova Receives Patent Allowance for Therapeutic Immune Privileged Cell Technologies

July 09, 2013 LONDON, ONTARIO (Marketwire - July 9, 2013) - Sernova Corp (TSX-V: SVA), today announced the Japan Patent Office has issued a Notice of Patent Allowance to Sernova for a patent entitled "The production of a biological factor and creation of an immunologically privileged environment using genetically altered Sertoli cells."

When transplanted into a recipient, Sertoli cells provide an immune privileged environment for therapeutic cells without the need for anti-rejection drugs. The claims of this patent relate to Sertoli cells themselves which can release factors in the body to treat a range of chronic diseases such as diabetes, Parkinson's disease, various cancers, hemophilia B and other blood diseases.

"This patent allowance further strengthens Sernova's intellectual property position and provides Sernova with the unique ability to use cells with therapeutic capabilities that are also naturally protected from immune system attack," stated Dr. Philip Toleikis, Sernova's President and CEO. "We envision our Cell Pouch(TM) transplanted with these immune privileged Sertoli cells and releasing the correct replacement factor for the treatment of a variety of diseases, without the need for anti-rejection medications. We believe such a product would be a significant advancement in the cell-based treatment of deficiency diseases."

Sernova's medical collaborators have presented evidence at leading scientific conferences demonstrating that the Cell Pouch(TM) is a safe and effective platform for the delivery of factors such as insulin from therapeutic cells. Sernova is developing the Cell Pouch(TM) as an enabling platform to treat multiple chronic debilitating diseases with immune protected, therapeutic cells and is currently evaluating the safety and efficacy of the Cell Pouch(TM) in human clinical trials for diabetes.

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Sernova Receives Patent Allowance for Therapeutic Cell Immune Protection Technology

June 24, 2013 LONDON, ONTARIO (Marketwire - June 24, 2013) - Sernova Corp. (TSX-V: SVA), today announced that the Australian Patent Office has issued a Notice of Patent Allowance to Sernova for a patent entitled "Adult sertoli cells and uses thereof".

Importantly, sertoli cells provide an immune privileged environment to protect donor therapeutic cells from immune system attack. When transplanted into Sernova's Cell Pouch(TM) with therapeutic cells, a safe, protected and efficacious environment is provided for therapeutic cells such as insulin-producing islets for the treatment of diabetes. The allowance of this patent will provide Sernova with patent protection through 2027 and similar patent applications have been filed in multiple countries around the world.

"The patent allowance strengthens Sernova's broad patent portfolio related to immune protection of therapeutic cells," stated Dr. Philip Toleikis, Sernova's President and CEO. "We believe the Cell Pouch(TM), proven to provide an ideal non-inflammatory, biocompatible environment, rich in matrix and microvessels for therapeutic cells, combined with sertoli local immune protection, provides the best combination of cell-based technologies to treat chronic diseases without the need for continuous anti-rejection drugs." Toleikis continued, "This strengthened patent portfolio has enabled us to expand our partnering and development opportunities as we continue to advance our Cell Pouch System(TM)."

Sernova has presented evidence at leading scientific conferences demonstrating that the Cell Pouch(TM) can be used as a safe and effective platform for the delivery of insulin from both autograft (self) and allograft (donor) islets to restore glucose control in stringent preclinical models of diabetes using the product scaled for humans. Sernova is currently evaluating the safety and efficacy of the Cell Pouch(TM) in humans in the first study of its kind in the world at the University of Alberta with Dr. James Shapiro as the principal investigator.

As the Company progresses, Sernova plans to explore the additional utility of the Cell Pouch(TM) as an enabling platform for a range of therapeutic cell types with the potential to treat multiple chronic debilitating diseases with broad unmet medical need.

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