Market Newsdesk

• Roflumilast foam demonstrated statistically significant improvement on the trial’s primary and multiple secondary endpoints
• Once-daily roflumilast foam demonstrated a favorable safety and tolerability profile
• Roflumilast foam potential “Best in Class” topical scalp and body psoriasis treatment
• Scalp psoriasis affects more than 2.5 million of the 6 million psoriasis patients in U.S with active disease
• Company to host a conference call today at 8:30 a.m. EST

WESTLAKE VILLAGE, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced positive top line data from its Phase 2b clinical trial evaluating ARQ-154 (topical roflumilast foam) as a potential treatment for scalp psoriasis.

Roflumilast foam 0.3% administered once daily for 8 weeks demonstrated statistically significant improvements compared to a matching vehicle foam on key efficacy endpoints in 304 adult and adolescent patients with plaque psoriasis that included plaques on the scalp. On the study’s primary endpoint of Scalp Investigator Global Assessment (S-IGA) success assessed at week 8, roflumilast foam 0.3% achieved a rate of 59.1% compared to a vehicle rate of 11.4% (p<0.0001). S-IGA success is defined as the achievement of an S-IGA score of ‘clear’ or ‘almost clear’ on a 5-grade scale plus at least a two-point change from baseline.   Onset was rapid, with significantly higher rates of S-IGA success noted as early as 2 weeks.

Multiple secondary endpoints were also met. On the key secondary endpoint of Body Investigator Global Assessment (B-IGA) success assessed at week 8, roflumilast foam 0.3% achieved a rate of 40.3% compared to a vehicle rate of 6.8% (p<0.0001), with separation from vehicle on B-IGA success as early as 2 weeks. Symptomatic improvement was also demonstrated, with 71.0% of subjects treated with roflumilast foam 0.3% who had a baseline Scalp Itch Numeric Rating Scale (SI-NRS) score of 4 or greater achieving an itch reduction of at least 4 points at week 8 compared to 18.5% of vehicle treated subjects (p<0.0001). Consistent with other clinical trials of topical roflumilast, roflumilast foam was well-tolerated, as evidenced by subject-reported local tolerability and rates of application site adverse events, treatment-related adverse events, and discontinuations due to adverse events low and similar to vehicle. Only 5 out of 200 subjects (2.5%) in the roflumilast foam treated group discontinued the study due to an adverse event, compared to 2 out of 104 subjects (1.9%) treated with the vehicle.

“Scalp psoriasis inflicts a high burden for patients, and current treatment options often carry significant treatment limitations that result in poor outcomes and can have a negative impact on patient quality of life,” said Leon Kircik, MD, Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, Indiana University Medical Center, and Medical Director, Physicians Skin Care, DermResearch, and Skin Sciences. “Roflumilast once-daily foam demonstrated rapid and significant improvements in psoriasis signs and symptoms, including reducing itch in a meaningful way. These positive results are encouraging for patients and clinicians who are desperate for new treatments that can simplify disease management, can be used in all areas of the body, and can ultimately improve the patient experience.”

“Approximately 40 percent of the 6 million Americans afflicted with active, chronic psoriasis have scalp involvement, an area where treatment of scalp plaques is complicated by the difficulty of delivering topical drugs under the hair and to the surface of the skin,” said Linda F. Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, as well as Division Head of Dermatology at Henry Ford Health System in West Bloomfield, Michigan. “Novel treatments are needed, particularly ones like topical roflumilast foam that have the potential to be safe for chronic use; that are appropriate for application in hair-bearing areas where a cream, lotion, or ointment is not suitable; and that have demonstrated symptomatic improvement similar to high-potency steroids while also maintaining a favorable safety and tolerability profile. I believe these data demonstrate that once daily roflumilast foam could offer patients the efficacy and tolerability that they need. In my opinion, if approved, topical roflumilast foam has the potential to become an important treatment option for plaque psoriasis patients, particularly those with scalp involvement.”

“We are delighted with these data, in which topical roflumilast foam demonstrated meaningful symptomatic improvement, alongside a favorable safety and tolerability profile that supports chronic use,” said Patrick Burnett, M.D., Ph.D., FAAD, and Chief Medical Officer of Arcutis. “With once-a-day dosing, roflumilast foam potentially offers the convenience of a simple, single, non-steroidal solution for both scalp and non-scalp plaques. If successful in Phase 3 clinical trials and approved for commercialization, roflumilast foam will be the first novel mechanism of action for the treatment of scalp and body psoriasis in decades. We believe it has the potential to positively affect the symptoms and quality of life of the millions of patients who suffer from this distressing chronic skin condition.”

Management will host a conference call today at 8:30 a.m. EST to discuss these results. To access the call, please dial (833) 614-1393 (domestic) or (914) 987-7114 (international) prior to the scheduled conference call time and provide the conference ID 8960956. A live webcast of the call will be available on the “Investors” section of the company’s website, www.arcutis.com. An archived version of the webcast will be available on the Arcutis website after the call.

About Roflumilast Foam

Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4 inhibitor) that Arcutis is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp.

Roflumilast has been approved by the FDA for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to-300 fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

Arcutis believes roflumilast foam has significant potential as a treatment for scalp psoriasis and seborrheic dermatitis. Roflumilast foam is nearly identical to ARQ-151 (topical roflumilast cream), Arcutis’ investigational topical cream PDE4 inhibitor that has demonstrated symptomatic improvement and a favorable tolerability profile in Arcutis’ clinical trials in plaque psoriasis, as well as encouraging results in atopic dermatitis. Arcutis completed enrollment in DERMIS-1 and DERMIS-2, the Company’s pivotal Phase 3 clinical trials evaluating topical roflumilast cream as a potential topical treatment for plaque psoriasis, and the Company expects to announce topline data in the first quarter of 2021 and to submit a New Drug Application (NDA) submission by the end of 2021. In addition, following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), Arcutis plans to advance its program to develop topical roflumilast cream for the treatment of atopic dermatitis into Phase 3 clinical trials beginning in early 2021.

About Scalp Psoriasis

Scalp psoriasis is a manifestation of plaque psoriasis characterized by raised, red areas of skin (“plaques”) covered with a silver or white scale that occurs in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Approximately 40 percent of the estimated 8.6 million Americans with psoriasis have involvement of the scalp, and over a lifetime, up to 80 percent of psoriasis patients may experience scalp involvement. Scalp psoriasis plaques are identical to psoriatic plaques on other areas of the body; however, topical treatment of scalp plaques is complicated by the difficulty of delivering topical drugs under the hair and onto the skin. As with psoriatic plaques on other parts of the body, psoriasis on the scalp is often itchy and is sometimes painful. Scalp psoriasis can also be associated with hair loss, likely due to damage to the hair from excessive scratching, rubbing, or combing of the affected area. Often, patients require two or more medications to manage their disease when they have scalp involvement.

About Arcutis – Bioscience, applied to the skin.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis’ robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company’s lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow the company on LinkedIn and Twitter.

Forward Looking Statements

This press release contains “forward-looking” statements, including, among others, statements regarding roflumilast foam’s potential as a scalp and body psoriasis treatment and whether roflumilast cream’s Phase 2 results may be predictive of roflumilast foam’s potential clinical outcomes. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-Q filed with U.S. Securities and Exchange Commission (SEC) on November 5, 2020, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Investor
Contact:

Heather Rowe Armstrong
Vice President, Investor Relations & Corporate Communications
[email protected]
805-418-5006, Ext. 740 

A PDF accompanying this announcement is available at http://ml.globenewswire.com/Resource/Download/d3d13839-6109-4c6c-a20c-b9bb48d2c612

• Exciting geological phenomena contributes to thesis of significant copper potential beyond existing 2.5MT M&I and 6MT Inferred copper resources in the South Zone

TORONTO, Nov. 23, 2020 (GLOBE NEWSWIRE) —  Ascendant Resources Inc. (TSX: ASND) (“Ascendant” or the “Company”) is pleased to provide an update on its on-going drill program on the South Zone at its Lagoa Salgada Project on the Iberian Pyrite belt in Portugal. The Company remains focused on expanding the known mineralization of the copper-rich South Zone. The Company has already published a robust PEA based upon an existing 10MT M&I resource in the North Zone (See PR January 14, 2020).

The discovery of native copper in the drill core of hole LS_ST_23 in addition to the expected massive sulfide and copper stockwork mineralization has been highly encouraging. Native copper findings are extremely rare and are also a good indicator of the potential for copper mineralization. This positive indication also comes on the heels of other supportive developments from hole LS_ST_21 where the drilling encountered mineralization earlier than planned and intersected a gossan intersection indicative of nearby massive sulphide mineralization.

Chris Buncic, President & CEO of Ascendant stated, “We are excited to continue our exploration activities in the South Zone where the occurrence of native copper in the drill core is highly prospective.Native copper is not a common occurrence, largely isolated to the copper belts in Chile, Namibia, the Upper Peninsula in Michigan, and Pinto Valley in Arizona. The fact that we have found this unusual occurrence at Lagoa Salgada is certainly consistent with our expectations of finding more copper-rich stockwork mineralization in the South Zone.”

The exploration program in the South Zone is intended to expand and upgrade the copper-rich resources in the Central and South Zones. This program builds upon the highly economic Preliminary Economic Assessment released on January 14, 2020 for the North Zone, in which the Company demonstrated the potential for a stand-alone high-grade polymetallic mining operation with an NPV₈ of US$106 million and an after-tax IRR of 31%. Commodity prices have improved considerably since this analysis was performed. An expansion of the South Resource should be accretive to the overall size of the Lagoa Salgada resource estimate, warranting further analysis of the scale and scope of potential future mining operations.

Drilling is set to continue through November and December with drill core assay results expected early in 2021. Please see the company website’s gallery for additional photos from this drill program, including core images, found at https://www.ascendantresources.com/English/Operations/Photo-Gallery/default.aspx.

Technical Disclosure/Qualified Person

All technical information contained herein has been reviewed and approved by Robert A. Campbell, M.Sc, P.Geo, an officer and director of the Company. Mr. Campbell is a “qualified person” within the meaning of NI 43-101 – Standards of Disclosure for Mineral Projects (“NI 43-101”).

About Ascendant Resources Inc.

Ascendant Resources Inc. is a Toronto-based mining company focused on the exploration and development of the highly prospective Lagoa Salgada VMS project located on the prolific Iberian Pyrite Belt in Portugal. Through focused exploration and aggressive development plans, the Company aims to unlock the inherent potential of the project, maximizing value creation for shareholders.

Lagoa Salgada contains over 12.8 million tonnes of M&I Resources and over 10.3 million tonnes in Inferred Resources and demonstrates typical mineralization characteristics of Iberian Pyrite Belt VMS deposits containing zinc, copper, lead, tin, silver and gold. Extensive exploration upside potential lies both near deposit and at prospective step-out targets across the large 10,700ha property concession. The project also demonstrates compelling economics with scalability for future resource growth in the results of the Preliminary Economic Assessment completed in 2020. Located just 80km from Lisbon, Lagoa Salgada is easily accessible by road and surrounded by exceptional Infrastructure. Ascendant holds a 21.25% interest in the Lagoa Salgada project through its 25% position in Redcorp – Empreendimentos Mineiros, Lda, (“Redcorp”) and has an earn-in opportunity to increase its interest in the project to 80%. Mineral & Financial Investments Limited owns the additional 75% of Redcorp. The remaining 15% of the project is held by Empresa de Desenvolvimento Mineiro, S.A. (EDM), a Portuguese Government owned company supporting the strategic development of the country’s mining sector. The Company’s interest in the Lagoa Salgada project offers a low-cost entry to a potentially significant exploration and development opportunity, already demonstrating its mineable scale.

Ascendant Resources is also engaged in the ongoing evaluation of producing and development stage mineral resource opportunities. The Corporation’s common shares are principally listed on the Toronto Stock Exchange under the symbol “ASND”. For more information on Ascendant Resources, please visit our website at www.ascendantresources.com.

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

For further information please contact:

Katherine Pryde
Communications & Investor Relations
Tel: 888-723-7413
[email protected]

Forward Looking Information

This news release contains “forward-looking statements” and “forward-looking information” (collectively, “forward-looking information”) within the meaning of applicable Canadian securities legislation. All information contained in this news release, other than statements of current and historical fact, is forward-looking information. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “budget”, “guidance”, “scheduled”, “estimates”, “forecasts”, “strategy”, “target”, “intends”, “objective”, “goal”, “understands”, “anticipates” and “believes” (and variations of these or similar words) and statements that certain actions, events or results “may”, “could”, “would”, “should”, “might” “occur” or “be achieved” or “will be taken” (and variations of these or similar expressions). Forward-looking
information is also identifiable in statements of currently occurring matters which may continue in the future, such as “providing the Company with”, “is currently”, “allows/allowing for”, “will advance” or “continues to” or other statements that may be stated in the present tense with future implications.
All of
the forward-looking information in this news release is qualified by this cautionary note.

Forward-looking information in this news release includes, but is not limited to, statements regarding the exploration activities and the results of such activities at the Lagoa Salgada Project, the ability of the Company to advance the Lagoa Salgada Project to a Preliminary Economic Assessment, and the ability of the Company to fund the exploration
activities
. Forward-looking information is based on, among other things, opinions, assumptions, estimates and analyses that, while considered reasonable by Ascendant at the date the forward-looking information is provided, inherently are subject to significant risks, uncertainties, contingencies and other factors that may cause actual results and events to be materially different from those expressed or implied by the forward-looking information. The material factors or assumptions that Ascendant identified and were applied by Ascendant in drawing conclusions or making forecasts or projections set out in the forward-looking information include, but are not limited to, the success of the exploration activities at Lagoa Salgada Project, the Company advancing the project to a Preliminary Economic Assessment, the ability of the Company to fund the exploration program at Lagoa Salgada, and other events that may affect Ascendant’s ability to develop its project; and no significant and continuing adverse changes in general economic conditions or conditions in the financial markets.

The risks, uncertainties, contingencies and other factors that may cause actual results to differ materially from those expressed or implied by the forward-looking information may include, but are not limited to, risks generally associated with the mining industry, such as economic factors (including future commodity prices, currency fluctuations, energy prices and general cost escalation), uncertainties related to the development and operation of Ascendant’s projects, dependence on key personnel and employee and union relations, risks related to political or social unrest or change, rights and title claims, operational risks and hazards, including unanticipated environmental, industrial and geological events and developments and the inability to insure against all risks, failure of plant, equipment, processes, transportation and other infrastructure to operate as anticipated, compliance with government and environmental regulations, including permitting requirements and anti-bribery legislation, volatile financial markets that may affect Ascendant’s ability to obtain additional financing on acceptable terms, the failure to obtain required approvals or clearances from government authorities on a timely basis, uncertainties related to the geology, continuity, grade and estimates of mineral reserves and resources, and the potential for variations in grade and recovery rates, uncertain costs of reclamation activities, tax refunds, hedging transactions, as well as the risks discussed in Ascendant’s most recent Annual Information Form on file with the Canadian provincial securities regulatory authorities and available
on SEDAR.

Should one or more risk, uncertainty, contingency, or other factor materialize, or should any factor or assumption prove incorrect, actual results could vary materially from those expressed or implied in the forward-looking information. Accordingly, the reader should not place undue reliance on forward-looking information. Ascendant does not assume any obligation to update or revise any forward-looking information after the date of this news release or to explain any material difference between subsequent actual events and any forward-looking information, except as required by applicable law.

Company Committed to Advancing
Omecamtiv
Mecarbil
with
Initial
Focus on Preparation
s for Regulatory Interactions Following Positive Results of GALACTIC-HF

Company to Host Conference Call and Webcast Today at
8:30
AM
Eastern Time

SOUTH SAN FRANCISCO, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Amgen has elected to terminate the Collaboration and Option Agreement, dated December 20, 2006 between the companies (the “Agreement”) and thereby end its collaboration with Cytokinetics, effective May 20, 2021, and intends to transition development and commercialization rights for omecamtivmecarbil and AMG 594 to Cytokinetics. Omecamtivmecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. AMG 594, a novel mechanism cardiac troponin activator, is in Phase 1 development for HFrEF and other types of heart failure.

“We believe this is an important pivot point and opportunity for our company, as we reclaim omecamtivmecarbil following positive Phase 3 clinical trial results,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In one of the largest heart failure clinical trials ever conducted, our novel mechanism drug candidate demonstrated positive efficacy in a diverse patient population with high unmet need and without an imbalance in the overall incidence of adverse events. We look forward to rapidly advancing next steps for omecamtivmecarbil, which we expect will include discussions with regulatory authorities. We believe we are well prepared to press forward given our strong balance sheet and pioneering leadership in the development of muscle-directed therapies.”

Terms of Termination

Pursuant to the terms of the Agreement, upon the effective date of Amgen’s termination, research, development and commercialization rights for compounds, including omecamtiv mecarbil and AMG 594, will transition to Cytokinetics. In addition, Amgen will have certain obligations set forth in the Agreement, including: cooperating with Cytokinetics and its designee(s) to facilitate a reasonably smooth, orderly and prompt transition of the programs, including transfer and assignment to Cytokinetics of specified regulatory filings, data and other information; if requested by Cytokinetics, transferring inventory of compounds to Cytokinetics at Cytokinetics’ expense; to the extent possible and requested by Cytokinetics, assigning relevant third-party manufacturing agreements to Cytokinetics; and granting to Cytokinetics exclusive and non-exclusive licenses to certain intellectual property rights. Cytokinetics will have no trailing royalty payment obligations to Amgen for either omecamtivmecarbil or AMG 594. With Cytokinetics’ consent, Amgen granted a sublicense to Les Laboratoires Servier and Institut de Recherches Internationales Servier (“Servier”) to commercialize omecamtiv mecarbil in Europe and the Commonwealth of Independent States, including Russia. Cytokinetics is party to a letter agreement with Amgen and Servier entered into in 2016, which provides that if Amgen’s rights to omecamtiv mecarbil are terminated, (i) the sublicensed rights previously granted by Amgen to Servier with respect to omecamtiv mecarbil, will remain in effect post termination of the Agreement and become a direct license or sublicense of such rights by Cytokinetics to Servier, on substantially the same terms as those in the Option, License and Collaboration Agreement between Amgen and Servier, and (ii) Amgen will, at Cytokinetics’ election, transfer to Cytokinetics or its designee (including Servier) certain ongoing development activities.

GALACTIC-HF
:
Results and
Next Steps

Primary results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 event-driven cardiovascular outcomes clinical trial of omecamtiv mecarbil, were recently presented at the American Heart Association (AHA) Scientific Sessions 2020, and were simultaneously published in the New England Journal of Medicine.¹

GALACTIC-HF, one of the largest Phase 3 global cardiovascular outcomes trials in heart failure ever conducted, enrolled 8,256 patients who were at risk of hospitalization and death, despite being well treated on standard of care therapy. After a median duration of follow-up of 21.8 months, the trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care. No reduction in the secondary endpoint of time to CV death was observed and no other secondary endpoints were met in accordance with the prespecified statistical analysis. The effect of omecamtiv mecarbil was generally consistent across prespecified subgroups and with a potentially greater treatment effect suggested in patients with a lower left ventricular ejection fraction.

Cytokinetics has received positive feedback from key heart failure opinion leaders on the primary results, with particular interest in the potential role of omecamtiv mecarbil in the treatment of advanced heart failure patients who remain at risk for hospitalization despite being treated with standard of care regimens. The company will be conducting market research to gain additional feedback from physicians and payors to inform the potential path forward. Cytokinetics expects to seek regulatory feedback regarding a potential registration path for omecamtivmecarbil, subject to cooperation and transitions from Amgen. In parallel, Cytokinetics plans to conduct commercial readiness assessments and to evaluate potential partnering opportunities, including co-promotion options in North America as well as licensing in other territories.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will host a conference call and webcast today, November 23, 2020, at 8:30 AM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 2184075.

An archived replay of the webcast will be available via Cytokinetics’ website until December 7, 2020. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 2184075 from November 23, 2020 at 11:30 AM Eastern Time until December 7, 2020.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is preparing for regulatory interactions for omecamtiv mecarbil, its novel cardiac muscle activator, following positive results from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with heart failure. Cytokinetics is conducting METEORIC-HF, a second Phase 3 clinical trial of omecamtivmecarbil. Cytokinetics is also developing CK-274, a next- generation cardiac myosin inhibitor, for the potential treatment of hypertrophic cardiomyopathies (HCM). Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics is also developing reldesemtiv, a fast skeletal muscle troponin activator for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is considering potential advancement of reldesemtiv to Phase 3 pending ongoing regulatory interactions. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the GALACTIC-HF clinical trial; statements relating to the METEORIC-HF clinical trial; Cytokinetics’ activities to advance the development of omecamtivmecarbil; the potential benefits of omecamtivmecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; the potential approval of omecamtiv mecarbil by the FDA or any other regulatory authority; Amgen’s fulfillment of its undertakings regarding transition of the omecamtivmecarbil and AMG 594 programs to Cytokinetics; any decision on the part of Servier to maintain or terminate its sublicense in respect of omecamtivmecarbil prior to the effectiveness of the termination of the Amgen-Cytokinetics collaboration; Cytokinetics’ and its partners’ research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics’ other drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen’s decisions and activities with respect to the transfer of rights to develop and commercialize omecamtivmecarbil and AMG 594 to Cytokinetics; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Communications, Investor Relations
(415) 290-7757

References

1. Teerlink J et al. NEJM. 2020

TORONTO, Nov. 23, 2020 (GLOBE NEWSWIRE) — Dundee Corporation (TSX: DC.A, DC.PR.B and DC.PR.D) (“Dundee” or the “Corporation”) announced today that it intends to commence a substantial issuer bid (the “Offer”) to purchase for cancellation from the holders thereof who choose to participate up to C$20,000,000 in value of its Class A subordinate voting shares in the capital of the Corporation (the “SV Shares”). The Offer is being made by way of a “modified Dutch auction”, which will allow holders who choose to participate in the Offer to individually select the price, within a price range of not less than C$1.40 and not more than C$1.60 per SV Share (in increments of C$0.05 per SV Share), at which they will tender their SV Shares to the Offer. Upon expiry of the Offer, the Corporation will determine the lowest purchase price (the “Purchase Price”) (which will not be less than C$1.40 and not more than C$1.60 per SV Share) based on all tenders validly deposited and not properly withdrawn pursuant to the Offer that will allow it to purchase the maximum number of SV Shares tendered to the Offer, having an aggregate purchase price not exceeding C$20,000,000.

The Corporation anticipates that the Offer will commence within the next week and will expire on January 11, 2021.

“This Offer is the next step towards the ongoing streamlining of our capital structure and is consistent with our goal of returning excess capital to shareholders when appropriate,” said Jonathan Goodman, President and CEO. “We are in a very strong financial position which allows us to proceed with this Offer, while maintaining a strong balance sheet and the financial flexibility needed to fund our strategic growth plan that is focused on the mining industry.”  

“Since I rejoined Dundee in early 2018, we have taken significant steps to lower our cost structure, reduce overall cash outflows, and decrease general and administrative expenses at the head office,” added Mr. Goodman. “Looking ahead, we wish to strike a balance to ensure we have sufficient capital to fund our investment in the mining strategy which we believe can deliver superior returns over the long-term, while returning capital to shareholders periodically in a prudent manner.”

“Earlier in 2020 we were able to retire approximately $49 million principal amount of our Cumulative 5-Year Rate Reset First Preference Shares, Series 2 for approximately $38.4 million,” said Robert Sellars, Executive Vice President and Chief Financial Officer. “That transaction was accretive to the Corporation and we believe that the Offer is similarly accretive to the Corporation, while providing liquidity to shareholders who wish to tender. The size of the Offer allows the Corporation to maintain a sufficient cash balance for future investment and ongoing general and administrative expenses and, as we continue to monetize legacy assets, we expect that the Corporation will enjoy even greater financial flexibility.”

Beginning in early 2018, the Corporation has focused on the implementation of its strategy of rationalizing its portfolio of investments and monetizing non-core assets as it exits business lines which are no longer deemed to be aligned with its longer-term mining-focused strategy. As part of this process, the Corporation has taken significant steps to streamline its capital structure and strengthen its balance sheet, most notably the monetization of its holdings in Dundee Precious Metals Inc. initiated in May 2020, and the acquisition and cancellation of approximately C$38.4 million of our Cumulative 5-Year Rate Reset First Preference Shares, Series 2 under our substantial issuer bid completed in September 2020.

In line with the Corporation’s longer-term strategy and commitment to creating value for the Corporation, the Board believes that the purchase of SV Shares under the Offer represents an attractive investment opportunity for Dundee and will be welcomed by certain holders of SV Shares who may wish to reduce their share ownership positions.

Additional Details of the Offer

If the Purchase Price is determined to be C$1.40 per SV Share (which is the minimum Purchase Price under the Offer), the maximum number of SV Shares that may be purchased by the Corporation under the Offer is 14,285,714 SV Shares, which represents approximately 14.3% of the SV Shares issued and outstanding as at November 20, 2020. If the Purchase Price is determined to be C$1.60 per SV Share (which is the maximum Purchase Price under the Offer), the maximum number of SV Shares that may be purchased by the Corporation under the Offer is 12,500,000 SV Shares, which represents approximately 12.5% of the SV Shares issued and outstanding as at November 20, 2020.

If SV Shares with an aggregate purchase price of more than C$20,000,000 are properly tendered and not properly withdrawn, the Corporation will purchase the SV Shares on a pro rata basis after giving effect to “odd lot” tenders (of holders beneficially owning fewer than 100 SV Shares), which will not be subject to pro-ration. In that case, all SV Shares tendered at or below the finally determined Purchase Price will be purchased, subject to pro-ration, at the same Purchase Price determined pursuant to the terms of the Offer. SV Shares that are not purchased, including all SV Shares tendered pursuant to auction tenders at prices above the Purchase Price, will be returned to shareholders.

The Offer and all deposits of SV Shares will be subject to the terms and conditions set forth in an offer to purchase, an accompanying issuer bid circular and a related letter of transmittal and notice of guaranteed delivery (all such documents, as amended or supplemented from time to time, collectively constitute and are herein referred to as, the “Offer Documents”). Further details of the Offer, including the terms and conditions thereof and instructions for tendering SV Shares, will be included in the Offer Documents. The Corporation anticipates that the Offer Documents will be mailed to shareholders, filed with the applicable Canadian securities regulatory authorities and made available without charge on SEDAR at www.sedar.com in accordance with applicable securities laws, as well as being posted on the Corporation’s website at www.dundeecorp.com, within the next week.

As at November 20, 2020, the Corporation had 99,977,913 SV Shares issued and outstanding. The SV Shares are listed and posted for trading on the Toronto Stock Exchange (the “TSX”) under the symbol “DC.A”. On November 20, 2020, the last full trading day prior to the day the terms of the Offer were publicly announced, the closing price of the SV Shares on the TSX was C$1.43.

The Corporation expects to fund any purchases of SV Shares under the Offer using the Corporation’s available cash on hand. All SV Shares purchased by the Corporation under the Offer will be cancelled.

The Offer is not conditional upon any minimum number of SV Shares being deposited. However, the Offer will be subject to certain conditions that are customary for transactions of this nature, all of which will be disclosed in the Offer Documents.

Dundee has retained RBC Dominion Securities Inc. (“RBC”) to act as financial advisor, Cassels Brock & Blackwell LLP (“Cassels”) to act as legal counsel and appointed Computershare Investor Services Inc. (the “Depositary”) to act as depositary for the Offer. Any questions or requests for information or assistance regarding the Offer may be directed to the Depositary at the contact details set out in the Offer Documents.

This news release is for informational purposes only and does not constitute an offer to buy or the solicitation of an offer to sell any SV Shares. The solicitation and the offer to buy SV Shares will only be made pursuant to the Offer Documents filed with the Canadian securities regulatory authorities. The Offer will not be made to, nor will deposits be accepted from or on behalf of, shareholders in any jurisdiction in which the making or acceptance of the Offer would not be in compliance with the laws of any such jurisdiction. However, Dundee
may, in its sole discretion, take such action as it may deem necessary to make the Offer in any such jurisdiction and to extend the Offer to shareholders in any such jurisdiction.

The Board has authorized and approved the Offer. However, none of Dundee, the Board, RBC, Cassels, or the Depositary makes any recommendation to any shareholder as to whether to deposit or refrain from depositing any or all of such shareholder’s SV Shares pursuant to the Offer or as to the purchase price or purchase prices at which shareholders may deposit SV Shares to the Offer. Shareholders are strongly urged to carefully review and evaluate all information provided in the Offer Documents, to consult with their own financial, legal, investment, tax and other professional advisors and to make their own decisions as to whether to deposit SV Shares under the Offer and, if so, how many SV Shares to deposit and the price or prices at which to deposit.

ABOUT DUNDEE CORPORATION

Dundee Corporation is a public Canadian independent holding company, listed on the Toronto Stock Exchange under the symbol “DC.A”. Through its operating subsidiaries, Dundee Corporation is engaged in diverse business activities in the areas of investment advisory, corporate finance, energy, resources, agriculture, real estate and infrastructure. Dundee Corporation also holds, directly and indirectly, a portfolio of investments mostly in these key areas, as well as other select investments in both publicly listed and private enterprises.

FOR FURTHER INFORMATION PLEASE CONTACT:

John Vincic
Investor and Media Relations for Dundee Corporation
Vincic Advisors
T: (647) 402-6375
E: [email protected]

Forward-Looking Statements

Forward-looking statements are included in this news release. These forward-looking statements are identified by the use of terms such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will”, “would”, and “should” and similar terms and phrases, including references to assumptions. Such statements may involve but are not limited to, Dundee’s plans, objectives, expectations and intentions, including Dundee’s objectives and expectations regarding the Offer and the size, timing and terms and conditions of the Offer, the anticipated mailing date of the Offer Documents and commencement date of the Offer, the expectation that the Corporation will enjoy even greater financial flexibility as it continues to monetize legacy assets, and other comments with respect to strategies, expectations, planned operations or future actions. Forward-looking statements, by their nature, are based on assumptions and are subject to important risks and uncertainties. Any forecasts, predictions or forward-looking statements cannot be relied upon due to, among other things, changing external events and general uncertainties of the business and its corporate structure. Results indicated in forward-looking statements may differ materially from actual results for a number of reasons. The forward-looking statements contained herein are subject to change. However, Dundee disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required under applicable securities regulations.

NOIDA, India and JOHNS CREEK, Ga., Nov. 23, 2020 (GLOBE NEWSWIRE) — EbixCash, a fully-owned subsidiary of Ebix, Inc. (NASDAQ: EBIX), a leading international supplier of On-Demand software and E-commerce services to the insurance, financial, healthcare and e-learning industries, today announced that it has acquired a 70 percent stake in a 1,800 person, pan-India based BPO company AssureEdge Global Services.

AssureEdge is today recognized as the first independent customer retention and customer response organization in India, with a vareiety of BPO offerings via six contact centers across the country. AssureEdge serves a number of industries and clients that have cross-selling value for EbixCash services. AssureEdge focuses on top priority areas like sales, fulfillment and customer retention for its clients. The Company today services 34+ large corporate clients, including some very well known names in the BFSI, telecom, entertainment and ecommerce sectors. For more information, visit the Company’s website at https://www.assureedgeglobal.com

Based on client commitments, AssureEdge is presently committed to growing its employee strength to 2,500 by the end of March 2021. The Company presently has a strong focus on growing its Human Resource Outsouring (HRO) and Last Mile Delivery (LMD) verticals, and is targeting 35% to 50% organic growth in the year 2021. AssureEdge presently generates approximately 30% EBITDA margins.

AssureEdge CEO and Founder Bhupesh Tambe will continue to lead the Company with a 30 percent stake in the venture. A proven leader with global experience of over 30 years and specializing in rapid growth and turnaround opportunities, Bhupesh will be immediately focusing his energies on AssureEdge integration into EbixCash, the immediate growth opportunities and the synergies offered by the integration. As a part of empowering AssureEdge, the Company will be rebranded as EbixCash Global BPO services.

Robin Raina, Chairman of the Board, President & CEO, Ebix, said: “AssureEdge can serve to handle fulfillment, collections and last mile delivery for EbixCash, as we converge it with our EbixCash financial and insurance technology platforms. We see AssureEdge serving our pre-sales and post-sales support for the BSE Ebix insurance platform, besides helping us provide an end-to-end fulfillment solution to banks on our lending, wealth management, asset management and credit card processing solutions for banks and financial institutions.”

About EbixCash and Ebix, Inc.

With a “Phygital” strategy that combines 320,000 physical distribution outlets in many Southeast Asian Nations (“ASEAN”) countries, to an Omni-channel online digital platform, the Company’s EbixCash Financial exchange portfolio encompasses leadership in areas of domestic & international money remittance, foreign exchange (Forex), travel, pre-paid & gift cards, utility payments, lending, wealth management etc. in India and other markets. EbixCash’s Forex operations have emerged as a leader in India’s airport Foreign Exchange business with operations in 32 international airports including Delhi, Mumbai, Bangalore, Hyderabad, Chennai and Kolkata, conducting over $4.8 billion in gross transaction value per year. EbixCash’s inward remittance business in India conducts approx. $6.5 billion gross annual remittance business, confirming its undisputed leadership position in India. EbixCash, through its travel portfolio of Via and Mercury, is also one of Southeast Asia’s leading travel exchanges with over 2,200+ employees, 212,450+ agent network, 25 branches and over 9,800 corporate clients; processing an estimated $2.5 billion in gross merchandise value per year. For more information, visit the Company’s website at www.ebixcash.com

With 50+ offices across 6 continents, Ebix, Inc., (NASDAQ: EBIX) endeavors to provide On-Demand software and E-commerce services to the insurance, financial, healthcare and e-learning industries. In the Insurance sector, Ebix’s main focus is to develop and deploy a wide variety of insurance and reinsurance exchanges on an on-demand basis, while also, providing Software-as-a-Service (“SaaS”) enterprise solutions in the area of CRM, front-end & back-end systems, outsourced administration and risk compliance services, around the world. For more information, visit the Company’s website at www.ebix.com

Contact details:

Darren Joseph

[email protected] or 678 281 2027

David Collins or Chris Eddy

Catalyst Global – 212-924-9800 or [email protected]

TORONTO, Nov. 23, 2020 (GLOBE NEWSWIRE) — Bunker Hill Mining Corp. (the “Company”) (CSE: BNKR) is pleased to announce that it has successfully renegotiated its option agreement for the purchase of a 100% interest in the saleable assets at the Bunker Hill Mine complex from Placer Mining Corporation (the “Lessor”). Under the new terms, the purchase price has been decreased by 30% from USD11.0 million to USD7.7 million.

Sam Ash, CEO of Bunker Hill Mining, stated:
“We are very pleased to have successfully negotiated a lower purchase price for the option agreement as it allows us to further focus our efforts on the ongoing high-grade silver exploration campaign and the mining restart plan. Under the terms of the agreement, we will be able to continue to explore, finalize the studies, and restart mining activities before being required to exercise the purchase option in August 2022. This offers a unique opportunity to optimize our working capital requirements and focus our balance sheet on the development of the asset.

Our
silver-focused exploration program
is continuing to progress well and we are excited to publish drill results in the upcoming weeks. We have recently
completed
6,000
feet of drilling from surface
and are now
moving
the
drill
rigs to
underground
platforms
to avoid any winter-related delays.
”

Bunker Hill Mining’s option agreement expires on August 1, 2022. Under the new terms of the amended agreement, the total consideration has been reduced by 30% to USD7.7 million, consisting of USD5.4 million payable in cash and USD 2.0 million in shares of the Company. The reference price for the payment in shares will be based on the share price of the last equity raise before the option is exercised. The Company will continue to make a monthly care and maintenance payment of USD60,000 to the Lessor in return for on-going technical support to the Company. Under the amended agreement, the Company’s contingent obligation to settle USD1.8 million of accrued payments due to the Lessor, if the Company decides not to exercise its right to purchase, has been waived. Under the amended agreement, the Company is to make an advance payment of USD2.0 million to the Lessor which shall be credited toward the purchase price of the Bunker Hill Mine when the Company elects to exercise its purchase right.

About Bunker Hill Mining Corp.

Bunker Hill Mining Corp. has an option to acquire 100% of all saleable assets at the Bunker Hill Mine. Information about the Company is available on its website, www.bunkerhillmining.com, or within the SEDAR and EDGAR databases.

For additional information contact:

Sam Ash, President and Chief Executive Officer
+1 208 786 6999
[email protected]

Cautionary Statements

Certain statements in this news release are forward-looking and involve a number of risks and uncertainties. Such forward-looking statements are within the meaning of that term in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, as well as within the meaning of the phrase ‘forward-looking information’ in the Canadian Securities Administrators’ National Instrument 51-102 – Continuous Disclosure Obligations. Forward-looking statements are not comprised of historical facts. Forward-looking statements include estimates and statements that describe the Company’s future plans, objectives or goals, including words to the effect that the Company or management expects a stated condition or result to occur. Forward-looking statements may be identified by such terms as “believes”, “anticipates”, “expects”, “estimates”, “may”, “could”, “would”, “will”, or “plan”. Since forward-looking statements are based on assumptions and address future events and conditions, by their very nature they involve inherent risks and uncertainties. Although these statements are based on information currently available to the Company, the Company provides no assurance that actual results will meet management’s expectations. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. Forward looking information in this news release includes, but is not limited to, the Company’s intentions regarding its objectives, goals or future plans and statements. Factors that could cause actual results to differ materially from such forward-looking information include, but are not limited to: the ability to predict and counteract the effects of COVID-19 on the business of the Company, including but not limited to the effects of COVID-19 on the price of commodities, capital market conditions, restriction on labour and international travel and supply chains; failure to identify mineral resources; failure to convert estimated mineral resources to reserves; the inability to complete a feasibility study which recommends a production decision; the preliminary nature of metallurgical test results; risks of
not
basing a production decision on a feasibility study of mineral reserves demonstrating economic and technical viability, resulting in increased uncertainty due to multiple technical and economic risks of failure which are associated with this production decision including, among others, areas that are analyzed in more detail in a feasibility study, such as applying economic analysis to resources and reserves, more detailed metallurgy and a number of specialized studies in areas such as mining and recovery methods, market analysis, and environmental and community impacts and, as a result, there may be an increased uncertainty of achieving any particular level of recovery of minerals or the cost of such recovery, including increased risks associated with developing a commercially mineable deposit with no guarantee that production will begin as anticipated or at all or that anticipated production costs will be achieved. Failure to commence production would have a material adverse impact on the Company’s ability to generate revenue and cash flow to fund operations. Failure to achieve the anticipated production costs would have a material adverse impact on the Company’s cash flow and future profitability; delays in obtaining or failures to obtain required governmental, environmental or other project approvals; political risks; changes in equity markets; uncertainties relating to the availability and costs of financing needed in the future; the inability of the Company to budget and manage its liquidity in light of the failure to obtain additional financing, including the ability of the Company to complete the payments
to the Lessor and the U.S. EPA
pursuant to the terms of the agreement to acquire the Bunker Hill Mine Complex; inflation; changes in exchange rates; fluctuations in commodity prices; delays in the development of projects; capital, operating and reclamation costs varying significantly from estimates and the other risks involved in the mineral exploration and development industry; and those risks set out in the Company’s public documents filed on SEDAR. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Cautionary Note to United States Investors Concerning Estimates of Measured, Indicated and Inferred Resources

This press release has been prepared in accordance with the requirements of the securities laws in effect in Canada, which differ from the requirements of U.S. securities laws. Unless otherwise indicated, all resource and reserve estimates included in this press release have been disclosed in accordance with NI 43-101 and the Canadian Institute of Mining, Metallurgy, and Petroleum Definition Standards on Mineral Resources and Mineral Reserves. NI 43-101 is a rule developed by the Canadian Securities Administrators which establishes standards for all public disclosure an issuer makes of scientific and technical information concerning mineral projects. Canadian disclosure standards, including NI 43-101, differ significantly from the requirements of the United States Securities and Exchange Commission (“SEC”), and resource and reserve information contained in this press release may not be comparable to similar information disclosed by U.S. companies. In particular, and without limiting the generality of the foregoing, the term “resource” does not equate to the term “reserves”. Under U.S. standards, mineralization may not be classified as a “reserve” unless the determination has been made that the mineralization could be economically and legally produced or extracted at the time the reserve determination is made. The SEC’s disclosure standards normally do not permit the inclusion of information concerning “measured mineral resources”, “indicated mineral resources” or “inferred mineral resources” or other descriptions of the amount of mineralization in mineral deposits that do not constitute “reserves” by U.S. standards in documents filed with the SEC. Investors are cautioned not to assume that any part or all of mineral deposits in these categories will ever be converted into reserves. U.S. investors should also understand that “inferred mineral resources” have a great amount of uncertainty as to their existence and great uncertainty as to their economic and legal feasibility. It cannot be assumed that all or any part of an “inferred mineral resource” will ever be upgraded to a higher category. Investors are cautioned not to assume that all or any part of an “inferred mineral resource” exists or is economically or legally mineable. Disclosure of
“contained ounces” in a resource is permitted disclosure under Canadian regulations; however, the SEC normally only permits issuers to report mineralization that does not constitute “reserves” by SEC standards as in-place tonnage and grade without reference to unit measures. The requirements of NI 43-101 for disclosure of “reserves” are also not the same as those of the SEC, and reserves disclosed by the Company in accordance with NI 43-101 may not qualify as “reserves” under SEC standards. Accordingly, information concerning mineral deposits contained in our website may not be comparable with information made public by companies that report in accordance with U.S. standards.