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• Award will help to fund planned Phase Ib/IIa study of inhaled murepavadin, a novel class antibiotic for the treatment of chronic Pseudomonas aeruginosa infections in cystic fibrosis
• Development program is currently jointly funded by Polyphor and the European Innovative Medicines Initiative (IMI) until end of planned Phase Ia study

ALLSCHWIL, Switzerland, Nov. 24, 2020 (GLOBE NEWSWIRE) — Polyphor AG (SIX: POLN) today announced a funding agreement with the Cystic Fibrosis Foundation to advance clinical development of its novel class antibiotic, inhaled murepavadin, in cystic fibrosis (CF). Inhaled murepavadin is a highly potent and selective antibiotic against Pseudomonas aeruginosa, including multidrug resistant strains. CF is characterized by chronic bacterial infection and severe inflammation that lead to progressive deterioration in lung function.

Under the terms of the agreement, Polyphor will be awarded up to USD $3.3 million to fund a Phase Ib/IIa clinical trial of inhaled murepavadin, as a follow-up study to a Phase Ia study in healthy volunteers using eFlow® Technology nebulizer (PARI Pharma GmbH), which is planned to be initiated pending CTA (clinical trial application) approval. The Phase Ib/IIa trial in adults with CF, assessing safety and tolerability (both overall and local) of ascending doses of inhaled murepavadin, is planned to be initiated in Q4 2021 following completion of the Phase Ia study. The Cystic Fibrosis Foundation Therapeutics Development Network (TDN) will provide support for the overall clinical development path for inhaled murepavadin.

“Pseudomonas aeruginosa infection is a leading cause of lung function decline in people with cystic fibrosis and our novel class antibiotic, inhaled murepavadin, has the potential to change the treatment paradigm transforming patients’ lives,” said Gokhan Batur, Chief Executive Officer of Polyphor. “This is Polyphor’s second award from the Cystic Fibrosis Foundation, whose support had made possible nearly every cystic fibrosis-specific drug available today. The award will further encourage clinical development of inhaled murepavadin, and we would like to thank the Cystic Fibrosis Foundation for their trust and ongoing support.”

About inhaled murepavadin:

Polyphor’s inhaled murepavadin is currently being developed as a precision antibiotic specifically targeting chronic Pseudomonas aeruginosa, for the treatment of these infections in people with CF. It is the first member of the Outer Membrane Protein Targeting Antibiotics (OMPTA), a novel class of antibiotics which was discovered by Polyphor and the University of Zurich and displays a unique mode of action. Based on the data of the inhaled murepavadin preclinical program suggesting significantly higher safety margins (at least 5-10 times) versus the intravenous formulation, Polyphor is planning to initiate the clinical development program. Until the end of the planned Phase Ia study the program is jointly funded by Polyphor and the European Innovative Medicines Initiative (IMI). Inhaled murepavadin is also part of the iABC project, a Europe-wide program dedicated to the development of inhaled antibiotics run by a consortium of leading lung specialists and research institutions in various European countries. The Cystic Fibrosis Foundation award will allow further development until the end of the Phase Ib/IIa study.

Infections remain a significant problem for people with CF who require novel treatment options, despite the availability of CFTR modulators. If approved for commercial use, inhaled murepavadin would be the first new class of antibiotics for Gram-negative pathogens in the last 50 years. It would also be potentially the first agent to target specifically Pseudomonas aeruginosa bacteria versus the current standard of care, broad spectrum inhaled antibiotics.

For further information please contact:

For Media:

Bernhard Schmid
LifeSci Advisors
+41 44 447 12 21
[email protected]

About Polyphor

Polyphor is a research-driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing best-in-class molecules in oncology and antimicrobial resistance leveraging the company’s leading macrocyclic peptide technology platform. Polyphor is advancing balixafortide (POL6326) in a Phase III trial in combination with eribulin in patients with advanced breast cancer and exploring its potential in other cancer indications. In addition, it has discovered and is developing the Outer Membrane Protein Targeting Antibiotics (OMPTA). OMPTA are potentially the first new class of antibiotics in clinical development in the last 50 years against Gram-negative bacteria. The company’s lead OMPTA program is an inhaled formulation of murepavadin for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. Polyphor is based in Allschwil near Basel and is listed on the SIX Swiss Exchange (SIX: POLN). For more information, please visit www.polyphor.com.

Disclaimer

This press release contains forward-looking statements which are based on current assumptions and forecasts of the Polyphor management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Polyphor’s results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Polyphor disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.

VANCOUVER, British Columbia, Nov. 24, 2020 (GLOBE NEWSWIRE) — Mydecine Innovations Group Inc. (the “Company”) (CSE:MYCO | OTC:MYCOF) announces that its previously issued financial statements for the fiscal year ended December 31, 2019, and the three- and six-month periods ended March 31, 2020 and June 30, 2020, any corresponding management’s discussion and analyses (collectively, the “Restated Documents”) will be restated and reissued.

During the fiscal year ended December 31, 2019, the Company recognized intangible assets in connection with the acquisitions of Relyfe Brand, LLC, Tealief Brand, LLC, and Drink Fresh Water, LLC. Upon further review, the assets do not meet the definition of intangible assets for the purposes of international financial reporting standards and as a result will be recorded as transaction costs in the Company’s statement of loss and comprehensive loss. The Restated Documents will reflect this change in the accounting treatment of the assets acquired in these acquisitions. The effect of the restatements does not impact the Company’s ongoing operations or cash position.

The Company intends to file the Restated Documents on or before November 30, 2020, in conjunction with the filing of the financial statements for the nine-month period ended September 30, 2020. The Restated Documents will replace and supersede the respective previously-filed financial statements and management’s discussion and analysis for such periods (collectively, the “Previous Documents”). The Previous Documents should no longer be relied upon.

On behalf of the Board of Directors

MYDECINE INNOVATIONS GROUP INC.

Joshua Bartch
Chief Executive Officer
[email protected]

About
Mydecine
Innovations Group

Mydecine Innovations Group™ is a life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing wellbeing. The company’s worldrenowned medical and scientific advisory board is progressing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada. Mydecine’s portfolio companies Mydecine Health Sciences™, Mindleap Health™, and NeuroPharm™ position the company at the forefront of disruptive modern medicine.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release.

Forward-looking Information Statement

This news release may contain certain “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian and United States securities laws. When used in this news release, the words “anticipate”, “believe”, “estimate”, “expect”, “target, “plan”, “forecast”, “may”, “schedule” and other similar words or expressions identify forward-looking statements or information. These forward-looking statements or information may relate to the
anticipated timing for the filing of the Restated Documents
, and other factors or information. Such statements represent the Company’s current views with respect to future events and are necessarily based upon
a number of
assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social risks, contingencies and uncertainties. Many factors, both known and unknown, could cause results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements. The Company does not intend, and does not assume any obligation, to update these forward-looking statements or information to reflect changes in assumptions or changes in circumstances or any other events affections such statements and information other than as required by applicable laws, rules and regulations.

Amsterdam, The Netherlands, November 24, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing innovative NK-cell-based medicines for the treatment of life-threatening diseases, today announces that Kiadis will participate in the 2020 Piper Sandler 32^nd Annual Virtual Healthcare Conference. Arthur Lahr, the company’s chief executive officer, will participate in a fireside chat and host one-on-one meetings with investors on Thursday, December 3, 2020.

A recording of the fireside chat may be accessed by visiting the “For Investors” section of the Company’s website under the “Events and Presentations“. A replay of the fireside chat will be available for 90 days.

Dutch Translation/Nederlandse vertaling

Kiadis Pharma N.V. (‘Kiadis’), een biofarmaceutisch bedrijf in de klinische fase dat innovatieve op NK-cellen gebaseerde geneesmiddelen ontwikkelt voor de behandeling van levensbedreigende ziekten, maakt bekend dat het zal deelnemen aan de virtuele 32^e Piper Sandler Health Conference. CEO Arthur Lahr zal op donderdag 3 december 2020 deelnemen aan een zogeheten ‘fireside chat’ en één-op-één meetings hebben met investeerders.

Een video-opname van de chat kan worden bekeken door naar het gedeelte “For Investors” te gaan op de Kiadis-website onder het tabblad “Events and Presentations“. Een replay van de fireside chat blijft 90 dagen beschikbaar.

Dit persbericht vormt een samenvatting van het gepubliceerde Engelstalige persbericht. Bij eventuele verschillen is de tekst van het Engelstalige persbericht altijd leidend.

Contacts

About Kiadis

Founded in 1997, Kiadis is building a fully integrated biopharmaceutical company committed to developing innovative cell-based medicines for patients with life-threatening diseases. With headquarters in Amsterdam, The Netherlands, and offices and activities across the United States, Kiadis is reimagining medicine by leveraging the natural strengths of humanity and our collective immune system to source the best cells for life.

Kiadis is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at www.kiadis.com.

Forward Looking Statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis’ or, as appropriate, Kiadis’ officers’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of known and unknown risks, uncertainties and assumptions that could cause actual results, performance, achievements or events to differ materially from those expressed, anticipated or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, regulation, competition and technology, can cause actual events, performance, achievements or results to differ significantly from any anticipated or implied development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or projections, or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the anticipated or implied developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

• If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options for the management of uterine fibroids:
  • 100 mg once daily for women with a contraindication to or who prefer to avoid hormonal add-back therapy (ABT)
  • 200 mg once daily with concomitant ABT for long-term use (beyond 6 months)
  • 200 mg once daily for short-term use, in particular when rapid reduction in fibroid volume is desired

• ObsEva expects to submit a new drug application to U.S. Food and Drug Administration in 1H:21

GENEVA, Switzerland and BOSTON, MA (November 24, 2020) – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for YSELTY® (linzagolix 100mg and linzagolix 200mg) for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids.

“The MAA submission is a major milestone for the company as it represents more than 5 years of drug development work by ObsEva team. I want to thanks all those who in the company or as subcontractors, as well as the more than 2,000 patients who contributed to this milestone. In developing multiple dose options, our long-term strategy has always been to meet the needs of the diverse population of women with uterine fibroids,” said Dr. Ernest Loumaye, founder and CEO of ObsEva. “Successful submission of the MAA brings us a step closer toward commercialization of Yselty, which will provide more women a potential best-in-class treatment for uterine fibroids.”

The Phase 3 clinical program in uterine fibroids comprises two pivotal trials, PRIMROSE 1 and PRIMROSE 2, that were designed to demonstrate the effectiveness and safety to support the claimed indication: management of HMB associated with uterine fibroids. The application is being submitted at this time as both Phase 3 studies have met their success criteria: both low and high doses of linzagolix with and without ABT are effective in the treatment of HMB associated with uterine fibroids and have an acceptable benefit risk profile.

The EMA is expected to notify ObsEva in December 2020 regarding the outcome of its validation of the MAA to ensure all essential regulatory elements required for a scientific assessment are included in the application prior to the start of the procedure.

About Linzagolix

Linzagolix (previously known as OBE2109) is a novel, oral, once daily, GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product.

About PRIMROSE 1 AND 2

PRIMROSE 1 (conducted in the United States, which enrolled 574 women with uterine fibroids) and the PRIMROSE 2 (conducted in Europe and in the United States, which enrolled 535 women with uterine fibroids) clinical trials are two Phase 3 clinical trials of linzagolix in patients with HMB associated with uterine fibroids. In both trials, patients were administered linzagolix doses of 100 mg or 200mg, both with and without hormonal ABT, or placebo. The primary endpoint of both trials was reduction in HMB at 24 weeks; responders were defined as patients with menstrual blood loss (MBL) of ≤ 80 mL and a ≥ 50 percent reduction from baseline in MBL, measured using the alkaline hematin method. Secondary endpoints included amenorrhea, time to reduced MBL, hemoglobin (Hb), pain, and quality of life (QoL). Safety endpoints included bone mineral density (BMD), and adverse events (AEs). Calcium/vitamin D were not provided. BMD was measured centrally via Dual Energy X-ray Absorptiometry (DEXA) scan at baseline and 24, 52, and 76 weeks (6-month post treatment assessment).

Both PRIMROSE trials successfully met the primary endpoint, with all doses showing statistically significant and clinically relevant reductions in HMB compared to placebo. There was a clear efficacy dose response, with the highest responder rates for the primary endpoint observed in women who received the 200 mg with ABT dose. Substantial improvements were also observed in all doses for the secondary endpoints of amenorrhea, time to reduced MBL and amenorrhea, hemoglobin levels in anemic subjects, pain, and quality of life.  The 200 mg dose alone showed rapid and substantial reduction in uterine and fibroid volume.

In PRIMROSE 1, the responder rate was 75.5% (p < 0.001) for patients receiving 200 mg with ABT and 56.4% for patients receiving 100 mg without ABT (p =0.003), compared to 35.0% in the placebo group. The overall safety profile was in line with expectations. The most frequently observed adverse events (occurring in > 5% of patients) were headache and hot flushes. Mean percentage changes from baseline in BMD were minimal, as expected with any GnRH antagonist treatment.

In PRIMROSE 2, the responder rate was 93.9% (p < 0.001) for patients receiving 200 mg with ABT and 56.7% for patients receiving 100 mg without ABT (p < 0.001), compared to 29.4% in the placebo group. The overall safety profile was in line with expectations. The most frequently observed adverse events (occurring in > 5% of patients) were headache, hot flushes, and anemia. Mean percentage changes from baseline in BMD were minimal and consistent with previous clinical data. 52-week results demonstrated that continued treatment with linzagolix provided sustained efficacy in the reduction of HMB; responder rates of 91.6% and 53.2% were observed in women receiving 200 mg with ABT and 100 mg without ABT, respectively. In addition, small incremental changes in BMD were observed at week 52 compared to week 24, suggesting the onset of plateauing BMD loss.

Additional follow-up data to be collected include PRIMROSE 1 52-week treatment results and 6-month post treatment assessment from both studies.

About ObsEva

ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving embryo transfer outcomes following in vitro fertilization. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.obseva.com.

About Kissei

Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and Unmet Medical Needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. KLH-2109/OBE2109 is a new chemical entity discovered by Kissei R&D.

Cautionary Note Regarding Forward Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the timing, advancement, best-in-class efficacy and potential therapeutic benefits of linzagolix, the potential for linzagolix to be a commercially competitive product, expectations regarding regulatory and development milestones, including the potential timing of regulatory submissions to the FDA, and the results of interactions with regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later stage clinical trials, related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, the impact of the novel coronavirus outbreak, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2019, the Risk Factors disclosed in ObsEva’s Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on November 5, 2020 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.ObsEva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

For further information, please contact:

CEO Office contact

Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550

Attachment

• Press Release in Pdf

Toronto, Nov. 24, 2020 (GLOBE NEWSWIRE) — University students, faculty, and academic librarians are struggling with social isolation, stress, and a lack of institutional support according to the results of a new poll which finds that those working and studying at Ontario’s universities believe the shift to online education has negatively impacted quality. Without immediate action from universities and the Ontario government to address these concerns, it is likely that quality will degrade even further.

“These results demonstrate that meaningful engagement between students and faculty is fundamental to the learning process,” said Rahul Sapra, President of the Ontario Confederation of University Faculty Associations. “As a result of the COVID-19 pandemic and the scramble to move courses online, we have lost that human connection and educational quality has suffered.”

The poll of 2,700 Ontario students, faculty, and academic librarians was commissioned by OCUFA and conducted by Navigator Inc. It reveals that 62 per cent of students and 76 per cent of faculty and academic librarians believe that the adjustments universities made to move teaching online have had a negative impact on education quality.

Financial security, care demands, and work-life balance are significant stress points for both groups. A third of students and two thirds of faculty and academic librarians revealed that they have care-giving responsibilities that they are struggling to balance while working or studying.

When asked about the impacts of the pandemic, a majority of students said they are concerned about their education quality and academic performance, their financial security as a result of high tuition fees and fewer opportunities to earn income, their mental health, and their ability to manage non-academic responsibilities, including caregiving, while studying.

“Since the beginning of the pandemic students have raised concerns about the quality and affordability of their education,” said Kayla Weiler, Ontario Representative of the Canadian Federation of Students. “These results further indicate that universities and the Ontario government must take action to improve learning and working conditions.”

Faculty and academic librarians, who have been working harder than ever during the past eight months to deliver the best education possible online, feel they are still falling short of their own expectations. With many universities making unilateral decisions about course delivery, a majority of faculty and academic librarians said they are concerned about their ability to teach and support students, their professional development, their mental health, and their ability to manage non-academic responsibilities, including caregiving, while working.

Financial security, mental health, and the challenges of balancing work and care responsibilities are of significantly higher concern to contract faculty. Most of these faculty work contract-to-contract with little job security, while receiving much lower pay than their securely-employed colleagues.

“Since this pandemic began, we have been hearing heart-wrenching stories from contract faculty across Ontario.” said Kimberly Ellis-Hale, a contract faculty member at Wilfrid Laurier University. “As dedicated instructors, we are committed to providing our students with exceptional educational experiences, but the reality is that, because we are contract faculty, we are not getting paid for the enormous amount of work it has taken to put these courses online and deliver them remotely, or to provide the additional support our students need and deserve. All this extra work and overtime is taking a heavy toll.”

The results of the poll also make it very clear that, even once the pandemic has ended, online education will not see the enthusiastic adoption that many have claimed. On the whole, neither students nor faculty view online learning as a desirable approach to a university education.

It is clear that most students, faculty, and academic librarians will not be returning to campus any time soon. However, there are still important actions Ontario’s universities can take to address these concerns. Reducing class sizes by hiring additional, securely employed faculty, will ensure students receive more one-on-one support and a better educational experience. Lowering tuition fees will help students struggling to make ends meet, now and after the pandemic. Finally, investments in better resources for students, faculty, and academic librarians—especially technology supports—would improve educational outcomes and address the mental and emotional burn-out many are feeling.

However, Ontario’s universities will have difficulty making these changes without additional support from the provincial government, which made substantial cuts to postsecondary education funding prior to the COVID-19 pandemic. The Ford government has displayed a pattern of behaviour by consistently ignoring those working on the frontlines of Ontario’s public education system. It is not too late to change course.

“Throughout the pandemic, the Ford government has stood on the sidelines and watched as university students, faculty, and academic librarians struggle,” said Sapra. “Even in the middle of the pandemic, the top concerns for students and faculty are fees and funding. It is time for the provincial government to step up, set an example, and invest in Ontario’s underfunded universities so that they can improve the educational experience and help students and faculty succeed.”

Reversing cuts to education by investing in smaller classes, good jobs, and lower tuition fees will not just help Ontario’s universities during the pandemic, but will lay the foundations for students, faculty, and academic librarians to effectively pivot back to the in-person educational experience they say is most effective.

For a copy of the poll results, click here.

Founded in 1964, OCUFA represents 17,000 professors and academic librarians in 30 faculty associations across Ontario. It is committed to enhancing the quality of higher education in Ontario and recognizing the outstanding contributions of its members towards creating a world-class university system. For more information, please visit the OCUFA website at 

www.ocufa.on.ca

.

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For more information or to arrange an interview, contact:
Ben Lewis, OCUFA Communications Lead at 416-306-6033 or [email protected]
Kayla Weiler, CFS-Ontario National Executive Representative at 519-901-0273 or [email protected]

Attachment

• OCUFA 2020 Faculty-Student Survey-opt