The New York Stock Exchange welcomes executives and guests of Zymeworks Inc. (NYSE: ZYME) in celebration of their recent listing on April 28, 2017. To honor the occasion, Dr. Ali Tehrani, President and Chief Executive Officer, will ring The NYSE Closing Bell®.
VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. (“Zymeworks”) today announced the pricing of its initial public offering of 4,500,000 common shares at a price to the public of U.S.$13.00 per share. In addition, Zymeworks has granted the underwriters a 30-day over-allotment option to purchase up to an additional 675,000 common shares at the initial public offering price, less underwriting discounts and commissions. Zymeworks expects to use the net proceeds from the offering to further develop and advance its pipeline of product candidates and to increase its liquidity.
The New York Stock Exchange has approved, and the Toronto Stock Exchange has conditionally approved, the listing of the common shares. The common shares are expected to begin trading on the New York Stock Exchange and on the Toronto Stock Exchange on an “if, as and when issued basis” on April 28, 2017 under the ticker symbol “ZYME.” The offering is expected to close on or about May 3, 2017, subject to the satisfaction of customary closing conditions.
Citigroup Global Markets Canada Inc., Barclays Capital Inc. and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering. Canaccord Genuity Corp. is acting as lead manager. Cormark Securities Inc. is acting as co-manager. MTS Securities, LLC served as financial advisor to Zymeworks in the offering.
A registration statement relating to the common shares was declared effective by the U.S. Securities and Exchange Commission on April 27, 2017. A final base PREP prospectus has been filed with, and a receipt has been issued by, the securities commissions or similar securities regulatory authorities in each of the provinces and territories of Canada containing important information relating to the common shares.
The offering is being made only by means of a prospectus. The prospectus contains important detailed information about the securities offered. A copy of the U.S. final prospectus, when available, related to the offering may be obtained from Citigroup Global Markets Canada Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone: (800) 831-9146, or by email at email@example.com; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone: (888) 603-5847, or by email at Barclaysprospectus@broadridge.com; or Wells Fargo Securities, LLC, Attn: Equity Syndicate, 375 Park Avenue, New York, NY 10152, by telephone: (800) 326-5897, or by email at firstname.lastname@example.org. Copies of the registration statement and U.S. final prospectus may also be obtained, when available, from www.sec.gov. A copy of the supplemented PREP prospectus, when available, related to the offering may be obtained from Canaccord Genuity Corp., Attn: Equity Capital Markets, 161 Bay Street, Suite 3000, Toronto, ON M5J 2S1, or by email at Ecm@canaccordgenuity.com; or Cormark Securities Inc., 200 Bay St Suite 2800, Toronto, ON M5J 2J2, by telephone: 416-943-6414, or by email at email@example.com. A copy of the supplemented PREP prospectus may also be obtained, when available, from www.sedar.com.
No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.
This press release contains certain forward-looking statements, including statements with regard to the use of proceeds from the offering and the expected closing of the offering. Words such as “expects”, “anticipates” and “intends” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the offering discussed above will be completed on the terms described. Completion of the proposed offering and the terms thereof are subject to numerous factors, many of which are beyond Zymeworks’ control, including, without limitation, failure of customary closing conditions and the risk factors and other matters set forth in Zymeworks’ filings with the U.S. Securities and Exchange Commission and the securities commissions or similar securities regulatory authorities in each of the provinces and territories of Canada. Zymeworks undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
David Matousek, 604-678-1388
Senior Manager, Investor Relations & Corporate Communications
Immunovaccine Announces Positive Interim Clinical Data from Ovarian Cancer Study of DPX-Survivac in Combination with Epacadostat
Preliminary Analysis Supports the Ability of Immunovaccine’s Lead Candidate to Induce T-Cell Infiltration
Early Data Reflect Tolerability and Clinical Potential of the Triple Combination Immunotherapy in Recurrent Ovarian Cancer
Halifax, Nova Scotia; March 29, 2017 – Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced the first interim data analysis from its ongoing Phase 1b clinical study of its novel T-cell activating immuno-oncology candidate, DPX-Survivac, in combination with epacadostat and low-dose cyclophosphamide. The analysis included the results of blood tests, tumor biopsies and CT scans to assess safety, disease progression and T-cell response for the first four evaluable patients in the trial.
All patients enrolled in the trial have recurrent ovarian cancer with evidence of progressive disease. Based on the interim analysis, the combination therapy appears to have an acceptable safety profile, with a single grade 3 and single grade 4 event reported and no serious adverse events (SAEs) reported.
At the time of the interim analysis, three of four patients exhibited stable disease, while a fourth patient continued to progress and discontinued the trial. In addition, researchers observed:
• Signs of increased T cell activity in tumors in three of the four patients based on RNA sequencing
• Stable disease with signs of tumor shrinkage in the patient who has been in trial for the longest duration thus far (based on CT scan at day 140)
“We are very encouraged by these early data, which are tremendously important to Immunovaccine, as they help to validate the underlying clinical potential of DPX-Survivac,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “Research is consistently demonstrating that activating T cells is a crucial mechanism to improving tumor response rates.(i) This desired mechanism of action is exactly what we have developed DPX-Survivac to address, and this data set has provided an encouraging first clinical demonstration of this effect.”
Immunovaccine is developing DPX-Survivac as a combination therapy that can significantly expand the range of cancers successfully treatable by novel immunotherapeutic agents. Emerging data from other studies have shown limited clinical efficacy of checkpoint inhibitor monotherapy in ovarian cancer, with response rates ranging from 10-15 percent.(ii)
Phase 1b Trial and Early Data
The Phase 1b company-sponsored clinical trial is a single-arm, open-label study of patients who have been diagnosed with platinum-resistant and sensitive ovarian cancer, and who have completed first-line treatment with measurable disease. Investigators plan to enroll up to 40 participants at up to ten sites in the U.S. and Canada. The study’s primary objective is to assess the safety and immunogenicity of the treatment, and to determine changes in the immune cell infiltration into tumors. Secondary objectives include objective response rate, duration of response, and time to progression.
Investigators are evaluating patients over a 12-month treatment schedule, collecting biopsy and blood samples before and after treatment. In addition, investigators are performing CT scans at the outset for each patient, repeating the scans every two months to evaluate status of the disease and to assess potential clinical benefit.
In addition to the early findings related to disease progression and the presence of survivin-antigen specific CD8+ T cells in the blood, analysis of the tumor revealed increases in multiple T cell markers, including cytotoxic markers and checkpoint inhibitor molecules.
“This readout, while from a limited number of patients, is important as it marks the first time DPX-Survivac has been tested in active progressive disease, where we can formally look at its impact on tumor progression and the tumor microenvironment, as well as assess potential clinical benefit,” said Marianne Stanford, PhD, Vice President, Research, at Immunovaccine. “The data set thus far has provided a preliminary indication of DPX-Survivac’s ability to induce T-cell infiltration in the tumor micro-environment. We are very encouraged by this information, and we look forward to the next opportunity to analyze the data and their related implications for this clinical program.”
Immunovaccine expects to complete enrollment and issue topline data by the end of 2017. Patients interested in enrolling in this trial can find more information via clinicaltrials.gov.
This triple combination study is the result of a collaboration between Immunovaccine and Incyte Corporation to assess the safety and effectiveness of DPX-Survivac, along with epacadostat, an investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) enzyme inhibitor, and low-dose cyclophosphamide in patients with recurrent ovarian cancer who have measurable disease.
About Ovarian Cancer
According to the American Cancer Society (ACS),(iii) ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Often diagnosed in its advanced stages, about 21,290 women received a new diagnosis of ovarian cancer in 2015; approximately 14,180 women would die from the disease, according to ACS estimates.
Ovarian cancer has a significant impact globally as well. The World Cancer Research Fund(iv) reports that ovarian cancer is the seventh most common cancer in women worldwide (18 most common cancer overall), with 239,000 new cases diagnosed in 2012.
DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ platform, which is a patented formulation that provides controlled and prolonged exposure of antigens to the immune system, resulting in a strong, specific and sustained immune response. The National Cancer Institute (NCI) has recognized survivin as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in multiple cancer types in addition to ovarian cancer, including breast, colon and lung cancers. Survivin plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in a higher percentage of tumors than other TAA’s.
The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T-cell immune response against cells presenting survivin peptides. This targeted therapy attempts to use the immune system to search actively and specifically for tumor cells and destroy them. Survivin-specific T-cells have been shown to target and kill survivin-expressing cancer cells while sparing normal cells.
DPX-Survivac has been granted Fast Track designation by the U.S. FDA as maintenance therapy in individuals with advanced ovarian, fallopian tube, and peritoneal cancer who have no measureable disease following surgery and front-line platinum/taxane chemotherapy to improve their progression-free survival.
About Epacadostat (INCB24360)
Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive enzyme that modulates the anti-tumor immune response by promoting regulatory T-cell generation and blocking effector T-cell activation, thereby facilitating tumor growth by allowing cancer cells to avoid immune surveillance. Epacadostat is a first-in-class, highly potent and selective oral inhibitor of the IDO1 enzyme that reverses tumor-associated immune suppression and restores effective anti-tumor immune responses. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitor pembrolizumab improved response rates compared with studies of the immune checkpoint inhibitors alone. A Phase 3 study, ECHO-301, evaluating the combination of epacadostat with the anti-PD-1 antibody pembrolizumab for the first-line treatment of patients with advanced or metastatic melanoma is underway. Ongoing Phase 1 and Phase 2 studies are also investigating epacadostat in combination with PD-1 and PD-L1 inhibitors in a variety of other cancer histologies.
Immunovaccine Inc. is a clinical-stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and infectious diseases. Immunovaccine develops T-cell activating cancer immunotherapies and infectious disease vaccines based on DepoVax™, the Corporation’s patented platform that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T-cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1b study with Incyte Corporation assessing its lead cancer therapy, DPX-Survivac, as a combination therapy in ovarian cancer. An investigator-sponsored Phase 2 study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide combined with an approved anti-PD-1 drug in advanced ovarian cancer. The Corporation is also exploring additional applications of DepoVax™, including DPX-RSV, an innovative vaccine candidate for respiratory syncytial virus (RSV), which has recently completed a Phase 1 clinical trial. Immunovaccine also has ongoing clinical projects to assess the potential of DepoVax™ to address malaria and the Zika virus. Connect at www.imvaccine.com.
Immunovaccine Forward-Looking Statements
This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals and the matters discussed under “Risk Factors and Uncertainties” in Immunovaccine’s Annual Information Form filed on Sedar. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.
Contacts for Immunovaccine:
Mike Beyer, Sam Brown Inc.
T: (312) 961-2502 E: firstname.lastname@example.org
Pierre Labbé, Chief Financial Officer
T: (902) 492-1819 E: Plabbe@imvaccine.com
Patti Bank, Managing Director, Westwicke Partners
O: (415) 513-1284
T: (415) 515-4572 E: email@example.com
(i) Patrick A. Ott, F. Stephen Hodi, Howard L. Kaufman, Jon M. Wigginton and Jedd D. Wolchok. Combination immunotherapy: a road map. Journal for ImmunoTherapy of Cancer (2017). 5:16 DOI 10.1186/s40425-017-0218-5
(ii) Gaillard SL, Secord AA, Monk B. 2016. The role of immune checkpoint inhibition in the treatment of ovarian cancer. Gynecologic Oncology Research and Practice. (3)11. DOI: 10.1186/s40661-016-0033-6
(iii) What Are the Key Statistics about Ovarian Cancer?” Cancer.org. The American Cancer Society, 12 Mar. 2015. Web. Accessed 29 Dec. 2015.
(iv) “Ovarian Cancer Statistics.” Cancer Facts and Figures – Data on Specific Cancers. World Cancer Research Fund International. Web. Accessed 29 Dec. 2015.
SutroVax Announces Closing of $64M via Series B Financing
- Announces achievement of pre-clinical proof-of-concept with lead program: Potential best-in-class pneumococcal conjugate vaccine
- Advancing lead into IND-enabling development to obtain clinical proof-of-concept
Foster City, CA, March 21, 2017 – SutroVax, a biopharmaceutical company dedicated to the delivery of best-in-class conjugate vaccines and novel complex antigen-based vaccines to prevent serious infectious diseases, today announced the closing of a $60 million Series B financing. The financing was led by new investors Frazier Healthcare Partners and Pivotal bioVenture Partners, and included participation from all existing investors: Abingworth, Longitude Capital, Roche Venture Fund and CTI Life Sciences Fund. In addition to Series B funds raised, the Company’s existing investors are investing an additional $4 million in SutroVax.
SutroVax will use the proceeds from this financing to advance its lead pneumococcal conjugate vaccine (PCV), which prevents invasive pneumococcal disease caused by Streptococcus pneumoniae, and accelerate the Company’s antigen discovery and early-stage development efforts in other disease areas. SutroVax’s broad-spectrum PCV is designed to provide expanded protection against circulating strains of pneumococcus and has the potential to replace the current vaccines used in infants and adults. SutroVax has generated pre-clinical proof-of-concept in head-to-head studies with its broad-spectrum PCV compared to current vaccines using well accepted immunological endpoints.
“The closing of this round, which was highly competitive and oversubscribed, is an important milestone for SutroVax and reflects the significant achievements we have made in developing a pneumococcal conjugate vaccine product candidate with the potential to disrupt a market with annual sales of over $7 billion,” said Grant Pickering, CEO of SutroVax. “This financing enables us to advance our lead PCV program into the clinic and expand our R&D, clinical development and manufacturing organizations.”
SutroVax conjugate vaccines are developed utilizing the Company’s exclusive rights to Sutro Biopharma’s Xpress CF Platform, a cell-free protein synthesis technology. The platform represents a major advancement over conventional conjugate vaccine production methods, by enabling precise and consistent conjugation of antigens to site-specific locations on a protein carrier that do not impede T-cell help resulting in higher-potency conjugates. SutroVax is utilizing these more potent conjugates to develop a broader-spectrum PCV product.
“Frazier Healthcare Partners has followed SutroVax’s progress since its founding and is delighted to make SutroVax its first vaccine investment,” stated Patrick Heron, Managing General Partner.
Tachi Yamada, M.D., Frazier Venture Partner, former President of the Bill & Melinda Gates Foundation Global Health Program and former head of GlaxoSmithKline and Takeda Pharmaceuticals R&D added, “SutroVax’s lead product candidate and technology platform has the potential to deliver the next generation of vaccines for major infectious diseases including pneumococcal disease.”
“We are pleased to make SutroVax the pioneer investment from Pivotal bioVenture Partners, our recently closed inaugural fund. I am delighted to join with the preeminent group of life sciences investors backing the company,” said Tracy Saxton, Ph.D., Managing Partner. “We are excited by the Company’s differentiated approach and ground-breaking progress in developing a potential best-in-class pneumococcal conjugate vaccine to provide coverage of circulating pathogenic strains outside of the current standard of care.”
As part of the financing, Patrick Heron and Tracy Saxton will join the SutroVax Board of Directors.
About Frazier Healthcare Partners
Founded in 1991, Frazier Healthcare Partners is a leading provider of growth and venture capital to healthcare companies. With nearly $3.0 billion total capital raised, Frazier has invested in over 170 companies, with investment types ranging from company creation and venture capital to buyouts of profitable lower-middle market companies. The firm’s Growth Buyout team invests in healthcare and pharmaceutical services, medical products and related sectors. The Life Sciences team invests in therapeutics and related areas that are addressing unmet medical needs through innovation. Frazier has offices in Seattle, WA and Menlo Park, CA, and invests broadly across the US, Canada, and Europe.
About Pivotal bioVenture Partners
Pivotal bioVenture Partners is a newly launched, San Francisco-based venture capital firm investing in early stage biotechnology companies. Pivotal closed a $300 million fund, and its investment strategy is centered on identifying companies developing differentiated science from discovery to early clinical development with the potential to deliver transformative therapies. The Pivotal team includes experienced life science investors and entrepreneurs with a track record of venture investing and scientific acumen.
About Pneumococcal Disease and the Pneumococcal Vaccine Market
Pneumococcal disease is an infection caused by Streptococcus pneumoniae. This infection can cause a wide range of serious illnesses including pneumonia, meningitis and blood stream infection as well as ear and sinus infections. According to the Centers for Disease Control and Prevention (CDC), an estimated 900,000 Americans suffer from pneumococcal pneumonia each year and up to 400,000 hospitalizations occur in the US. In addition, about 18,000 older adults die each year from pneumococcal disease in the U.S. The market-leading vaccine is a 13-valent PCV, Prevnar 13®, that has worldwide sales of approximately $6 billion annually yet does not protect against a significant number of circulating strains of pneumococcus causing invasive disease in adults and children. In the U.S., the CDC’s Advisory Committee on Immunization Practices (ACIP) recommends all children aged two months to five years and immunocompromised children aged six years and older be vaccinated with Prevnar 13®. In addition, the ACIP recommends all adults aged 65 years and older and immunocompromised adults aged 19 years and older be vaccinated with Prevnar 13®and Pneumovax®, a 23-valent non-conjugate vaccine with over $600 million in annual sales.
SutroVax is an independent vaccine platform and development company whose mission is to deliver best-in-class conjugate vaccines and novel complex antigen-based vaccines to prevent serious infectious diseases. The company is leveraging its exclusive license to Sutro Biopharma’s Xpress CF platform to perform cell-free protein synthesis and site-specific conjugation for the field of vaccines. For more information, visit www.sutrovax.com.
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Toronto medical device company CellAegis Devices Inc has secured about $12.8 million (US$9.5 million) in a Series C financing. The round was led by Canadian venture capital firm CTI Life Sciences Fund and co-led by an undisclosed U.S. strategic investor. MaRS Catalyst Fund, Broadview Ventures and several family offices also invested. With the deal, Dr. Shermaine Tilley, a CTI managing partner, and Broadview’s Christopher Colecchi have joined the board. CellAegis has developed the non-invasive autoRIC Device, which delivers therapy to patients with cardiovascular conditions. It will use the funds raised to support U.S. clinical testing and commercialization.
CellAegis Devices Announces US$9.5 Million Financing to Support Clinical and Regulatory Advancement of its autoRIC® Device
TORONTO, March 14, 2017 /PRNewswire/ – CellAegis Devices Inc, a Toronto-based medical device company, today announced closing a US$ 9.5 million Series C financing to support a U.S. clinical trial and de novo 510(k) regulatory filing for marketing of its autoRIC Device as an adjunct therapy to stenting. This device automatically delivers Remote Ischemic Conditioning (RIC) to provide a non-invasive, cardio-protective therapy shown to reduce heart damage during heart attacks and other cardiovascular procedures. The autoRIC Device is approved by Health Canada and in Europe where it is being used in multiple large investigator-sponsored trials to assess its efficacy in reducing clinical events after a heart attack.
The financing was led by CTI Life Sciences Fund, a leading Canadian venture capital investor, and co-led by a U.S. based strategic investor. Other investors included MaRS Catalyst Fund, Broadview Ventures and strategic family offices.
Dr. Shermaine Tilley, Managing Partner in CTI Life Sciences Fund, and an appointee from the US Strategic will join CellAegis’ board of Directors. Christopher Colecchi, from Broadview Ventures’, will also serve as a Director.
“We are ready to advance clinical commercialization of autoRIC Device in the EU and Canada, complete the FDA trial and gain approval to open the US market,” said Rocky Ganske, Chief Executive Officer of CellAegis Devices. “This financing adds the experience of seasoned Canadian and U.S. medical technology investors, and demonstrates the support of our existing investors.”
Dr. Tilley stated, “CTI Life Sciences Fund is enthusiastic to provide capital to CellAegis at this important juncture in the company’s development. The autoRIC Device shows promise in significantly improving outcomes in cardiovascular and other organ systems following ischemic events such as heart attacks, and we look forward to facilitating its clinical testing and regulatory submission for the U.S. market.”
*CellAegis autoRIC Device is not cleared or approved for clinical use in the United States.
About CellAegis Devices.
CellAegis Devices (Toronto, Canada) has patented and developed the non-invasive autoRIC Device, which delivers Remote Ischemic Conditioning (RIC) therapy to patients with acute and chronic cardiovascular conditions. This medical procedure protects the heart as well as other organs from ischemia and reperfusion injury. The autoRIC Device has CE Mark and Health Canada approvals for treatment during heart attacks, cardiothoracic or surgical procedures. Investigator sponsored clinical research studies for chronic conditions such as heart failure and stroke are also underway. The autoRIC Device was developed from the clinical work of Dr. Andrew Redington and colleagues at the Hospital for Sick Children in Toronto, and funded in part by the Fondation Leducq’s Transatlantic Networks of Excellence.
About CTI Life Sciences Fund.
CTI Life Sciences Fund L.P. was created in 2006 and is based in Montreal. The firm makes venture capital investments mostly in high quality biotech and medtech companies at the pre-clinical and clinical development stages, in North America, and primarily in Canada. Since its second mandate in 2014, CTI Life Sciences Fund manages $245 million of assets. For more information, please visit www.ctisciences.com.
About Broadview Ventures.
Broadview’s mission is to accelerate the development of promising technology for the diagnosis and treatment of cardiovascular and neurovascular disease through targeted investments. For more information visit http://broadviewventures.org
About MaRS Catalyst Fund.
MaRS Catalyst Fund launched in 2016 provides funding and support to Canadian companies pursuing social and environmental outcomes with business models that scale. MaRS Catalyst focuses on businesses that can deliver better Health outcomes, provide a more sustainable Planet and support happier People through innovative education products and work sustainability services. For more information please visit www.marscatalystfund.ca
**CellAegis and autoRIC are registered Trademarks of CellAegis Devices Inc.
Photo courtesy of CellAegis Devices Inc
Profound Medical Corp. Completes Previously Announced $17.4 Million Bought Deal Offering of Common Shares
THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES.
TORONTO, Nov. 14, 2016 (GLOBE NEWSWIRE) — Profound Medical Corp. (“Profound” or the “Company”) (TSX-V:PRN) today announced that it has completed its previously announced bought deal offering of 15,820,000 common shares of the Company (“Common Shares”) at a price of $1.10 per Common Share (the “Offering”) for gross proceeds of approximately $17.4 million. The Offering was completed through a syndicate of underwriters led by GMP Securities L.P., and including Echelon Wealth Partners Inc. and Mackie Research Capital Corp.
The Common Shares were offered by way of a short form prospectus in all of the provinces of Canada as well as in the United States under applicable registration statement exemptions. The Company intends to use the net proceeds from the Offering (a) to support certain costs and expenses of the TACT Pivotal Clinical Trial; (b) for ongoing expansion of infrastructure to execute on European sales and marketing plans; and (c) for general corporate purposes, including working capital.
The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any State in which such offer, solicitation or sale would be unlawful.
About Profound Medical Corp.
The Profound team is committed to the effort to achieve a new therapeutic standard in prostate cancer. For the millions of men currently living with prostate cancer, and the thousands more who are diagnosed with it every year, current treatment options often mean having to make difficult choices based on potential side effects that can significantly impact quality of life. The Company’s mission is to profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate cancerous prostate tissue with precision, while actively protecting critical anatomy from potential side effects; a tomorrow where patients have access to a safe, fast and effective treatment option, so they can quickly return to their daily lives.
Established in 2008, Profound is commercializing a novel technology, TULSA-PRO™, which combines real-time Magnetic Resonance Imaging with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control that is designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects. TULSA-PRO™ is CE Marked and Profound is sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which is designed to further demonstrate the safety and effectiveness of this innovative technology.
Forward Looking Statements
This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For investor or media inquiries, please contact:
Profound Medical Corp.
Vice President, Finance
Profound Medical Corp.
Toronto’s Xagenic Inc. completes successful beta testing of X1 diagnostic system
The external study confirmed the feasibility of point-of-care testing using the X1 system, and that the CT/NG (combined chlamydia and gonorrhoea) test was able to generate results comparable to gold-standard molecular tests normally run at centralized labs.
“We are very excited about the progress of the X1 testing system and demonstrating its clinical utility during Beta testing,” said Xagenic COO Randall Wilhoite. “The information we have collected will inform the completion of the final design for the X1 and the development of menu for this first-in-class POC molecular testing system.”
Successful conclusion of this Beta testing precedes Xagenic’s plans for market launches in Europe and the U.S. in the near future.
Xagenic’s X1 system is a cartridge-based, point-of-care platform to test for infectious diseases, such as flu, strep and upper respiratory infections, although this first assay developed for the X1 system is a combined chlamydia and gonorrhoea (CT/NG) test designed to facilitate screening, diagnosis and rapid treatment of these common sexually-transmitted diseases.
The single-use cartridge system contains a proprietary sensor chip that enables direct detection of chlamydia and gonorrhea without the use of enzymes, and is an electrochemical amplification-based technology protected by 17 patent families globally.
The X1 system is intended to deliver a definitive test result during the time available during a typical on-site office consult with a physician, typically requiring less than a minute of physician hands-on time running with the device.
Normally, tests require that samples to be sent to centralized labs before results are obtained, a process that can last anywhere between two to seven days.
Bringing rapid on-demand testing to physician offices eliminates costs associated with that out-sourced transportation and testing infrastructure, while also improving patient compliance and outcomes, and reducing complications and unnecessary direct costs.
In 2015, Xagenic announced a $15 million round of financing, led by investors that had previously participated in its 2014 $25.5 million Series B round of funding, including Domain Associates, CTI Life Sciences, BDC Capital and the Ontario Capital Growth Corporation.
Between that and Xagenic’s $10 million in Series A funding, the company has raised $52.7-million in financing to date.
Xagenic has origins in the University of Toronto, and was launched in 2010 with $1 million seed money from MaRS Innovation, the Ontario Institute for Cancer Research, the Health Technologies Exchange, and the Ontario Centres of Excellence.
In 2015, Xagenic acquired exclusive rights to a mutation detection technology, developed by Dr. Shana Kelley, whose University of Toronto team has developed a close working relationship over the years with Xagenic.
That team published a study on the technology in Nature Chemistry, outlining its capacity to detect cell-free nucleic acids in blood plasma or serum, meaning that Xagenic’s platform would be able to run a kind of “liquid biopsy” or deliver results without taking a tissue sample.
Headquartered in Toronto, Xagenic also has a San Francisco office.
Venous infers: Early work sufficient to attract $21M for Ilkos’ leg ulcers effort
SEPTEMBER 28 , 2016
By Randy Osborne, Staff Writer
“The beauty of this deal is that it’s not just an out-licensing deal from Servier,” CTI Life Sciences partner Jean-François Leprince told BioWorld Today as he explained newly formed Laval, Quebec based Ilkos Therapeutics Inc., which made its debut with a $21 million three-way investment in equal parts by CTI, the Fonds de solidarité FTQ and Servier Canada.
Ilkos is developing a compound called S42909 for oral, first-line treatment of venous lower limb ulcers. The candidate was deprioritized from Servier’s research and development lineup, but the firm is still “highly interested” in it, Leprince said – interested enough that the company is overseeing phase IIa trials as part of the arrangement with Ilkos. “They remain investors into the newco in Quebec, and the newco is contracting Servier as, I would say, a service provider,” he said. “We will be using the Servier organization to run the phase IIa trials around Europe, Canada and the U.S.” The $21 million is “more than enough” to finish the dose-ranging trial, which will involve three doses and more than 200 patients, he added.
A nicotinamide adenine dinucleotide phosphate (NADPH) oxidase inhibitor, S42909 “has gone through a very intensive and complete phase Ia trial with more than 200 healthy volunteers,” he said. The outcome turned up data showing S42909 safe and well-tolerated. “We believe, rightly or wrongly – the future will tell – that there is enough de-risking or risk mitigation with this project,” he said. Servier, founded in 1954, is the first French independent pharmaceutical group.
About S42909, Leprince said, “at the very beginning, [venture capital fund CTI] had a little bit of skepticism, because this indication has been the graveyard of many drugs, not to mention the latest cellular therapies. But I must say that the pharmacological properties of the compound have been evidenced by very compelling preclinical results.” Servier, with “global leadership in vein disease” thanks to Daflon (micronized purified flavonoid fraction), makes the ideal partner, in his view. “Would it not have been that way, because of the challenge associated with the indication, we would not have done [the deal]. There is only one company with the kind of expertise in venous insufficiency that can operate a trial like that.”
Specifically, Daflon is indicated for symptoms of venolymphatic insufficiency (heavy legs, pain, restless leg at bedtime) and hemorrhoid attacks.
S42909 “goes one step beyond” Daflon to affect the causes of venous insufficiency, said Leprince. Along with Danny Gagné, manager of the Fonds de solidarité FTQ’s life sciences portfolio, and Frédéric Fasano, Servier Canada’s CEO, he will serve as director of Ilkos. Chairman of the board is Mark Beaudet, co-founder of St. Laurent, Quebec-based Paladin Labs Inc., acquired by Endo International plc, of Dublin, in 2013. (See BioWorld Today, Nov. 6, 2013.)
NEUROPATHY . . . AND ALZHEIMER’S?
In the microcirculation damage of venous insufficiency, three mechanisms are implicated: leukocyte additions to the endothelial wall; oxidative stress; and the presence of metalloproteinase-2. S42909 seems to influence all of those, Leprince said. “You will tell me, ‘OK, it’s animals,’ but we believe those animal models are very predictive of what could happen in humans,” he said. Currently, venous lower limb ulcers are treated with compression bandages and “some local, topical products that are used essentially to address the symptoms, i.e., inflammation [and] infections,” he said. “First, we want to demonstrate the efficacy of the compound in venous disease, which [makes up] 70 percent of the total ulcers. Second, maybe the indication we will be targeting is the prevention of recurrence of the venous ulcers. Healing the ulcers is already quite an achievement, but then you run the risk, especially with aged people, to suffer the recurrence. We may [later] contemplate what we call mixed ulcers, which is a combination of venous and arterial, but we are not yet at the level of arterial disease.”
Ilkos takes its name from the Greek for ulcer, “elkos,” with the first vowel changed to suggest illness and thence healing. “The concept is a kind of quasi-virtual company,” Leprince said. Ilkos will contract with Servier and others, intending along with the phase IIa trial to “stake a post in the ground with the beginning of a clinical development program in Japan,” while conducting some preclinical toxicology studies “which are longer-term, 26- week studies on animals,” he said.
A June paper in Experimental Dermatology described a two-week preclinical experiment in 24 New Zealand white rabbits. Researchers concluded that “S42909 improved [the] healing process by dampening excessive inflammation and facilitating collagen deposition without wound contraction phenomena,” and said the compound “might be a promising therapy to treat chronic wounds [such] as venous leg ulcers.”
The company is not alone in NADPH oxidase research. At the start of last year, Geneva-based Genkyotex SA raised CHF20 million (then US$20 million) in a series D round to take forward its pipeline of selective NADPH oxidase inhibitors in a broad range of indications, including diabetic neuropathy. In November 2015, the company gained orphan drug status from the FDA and EMA for GKT137831, its lead drug in the class, targeting systemic sclerosis. Another Swiss firm, Kareus Therapeutics SA, is trying an approach with NADPH in Alzheimer’s disease, though research is early stage. (See BioWorld Today, Jan. 7, 2013, and Jan. 8, 2015.) //