Applied DNA, EvviVax, and GVS Receive Regulatory Approval to Conduct Veterinary Clinical Trial for Linear COVID-19 Vaccine Candidate

Applied DNA, EvviVax, and GVS Receive Regulatory Approval to Conduct Veterinary Clinical Trial for Linear COVID-19 Vaccine Candidate

– Trial Redesigned to Accelerate Development of Clinical Path to Potential USDA APHIS Conditional License for Commercial Veterinary Sales –

STONY BROOK, N.Y.–(BUSINESS WIRE)–
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, EvviVax, S.R.L. (“EvviVax”), a spin-off of Takis Biotech with expertise in engineered veterinary cancer immunotherapy and targeted vaccines, and Veterinary Oncology Services at Guardian Veterinary Specialists (GVS), a multi-specialty veterinary hospital, announced the receipt of approvals from the New York State Department of Agriculture and Markets and the U.S. Department of Agriculture on an advanced clinical strategy to conduct a previously reported, New York State-based, veterinary trial of a lead LinearDNA™ COVID-19 vaccine candidate. The vaccine candidate is jointly developed by Applied DNA and EvviVax.

Applied DNA, EvviVax, and GVS also announced a redesign of the veterinary trial to allow for an acceleration of the lead candidate’s development path with the end goal of applying for a U.S. Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS) conditional license to enable commercial veterinary sales for domestic felines.

The goal of the trial remains to evaluate the vaccine candidate as a strategy for the prevention of SARS-CoV-2, the virus that causes COVID-19, in feline companions of humans that would mitigate the animals as a potential reservoir for infections in humans. Domestic felines are a known COVID-19 reservoir and can transmit the virus to other felines. No transmission back to humans has been documented, though the scientific possibility remains given the virus’s zoonotic origin. The trial will take place at GVS in Brewster, N.Y., and is expected to begin within the next 90 days.

The trial will now recruit a smaller number of healthy domestic feline companion animals that will receive two doses of the vaccine candidate and follow the enrolled cohort for up to six months. The trial’s primary endpoint is to demonstrate the safety and immunogenicity (detection of neutralizing antibodies and T-cell response) of the vaccine candidate in domestic felines. The vaccine candidate previously yielded strong antibody and T-cell responses even at very low doses in mice.

Trial Supervising Investigator and Diplomate of the American College of Veterinary Internal Medicine, Dr. Joseph Impellizeri, of GVS, stated, “By studying the immune response after immunizing an important host that resides with human counterparts, we hope to understand better the potential clinical response against the virus using a specially designed vaccine and delivery system that may translate to both human and animal protection.”

Accelerated Development of Clinical Path

The redesigned trial allows for immunologic data to be gathered faster across a smaller cohort that would also support the near-concurrent pursuit of a parallel trial (the “proposed trial”) currently being finalized to advance further data by challenging an additional cohort in a controlled environment with the lead vaccine candidate. Upon seroconversion, the vaccinated felines would then be placed among an infected COVID-19 feline cohort. The rates of transfer of the infection among the vaccinated cohort will be studied with a planned endpoint of revealing the vaccine candidate’s overall efficacy against active disease. The data from the redesigned and proposed trials may also provide additional support for requisite toxicology and bio-distribution studies to potentially initiate human SARS-CoV-2 vaccine candidate trials.

On the assumption that both trials’ primary endpoints are met, the Company and EvviVax expect to apply for a USDA APHIS conditional license (9 CFR 102.6) for a LinearDNA COVID-19 vaccine candidate for domestic felines. Conditional licensure is afforded to products that meet emergency needs, such as the COVID-19 outbreak, and potentially accelerates the vaccine candidate’s time-to-market.

“In accelerating our vaccine development program for veterinary application, we seek to elevate our work with EvviVax in the emerging field of SARS-CoV-2 susceptibility in animals,” said Dr. James A. Hayward, president and CEO, Applied DNA. “With the initiation of the redesigned veterinary trial, we progress towards potentially commercializing our lead LinearDNA vaccine candidate for use on domestic felines while also generating valuable complementary data for potential human COVID-19 vaccine candidate trials and charting a possible development path to other animals, such as mink. The virus’s impact on farmed mink populations globally has been especially devastating and has resulted in the collapse of Denmark’s $800 million mink fur industry1. Further, mink-linked SARS-CoV-2 virus mutations identified in humans have now spread to at least seven countries2. Should our veterinary COVID-19 vaccine gain conditional licensure, we believe it could have significant economic and public utility.”

Footnotes:

1https://www.reuters.com/article/us-health-coronavirus-denmark-mink-farme/it-stops-here-danish-mink-farmer-sees-no-future-after-mass-cull-idUSKBN27L2BN

2 https://amp.theguardian.com/environment/2020/nov/18/covid-19-mink-variants-discovered-in-humans-in-seven-countries

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.

Applied DNA is a member of the Russell Microcap® Index.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA), U.S. Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown ability to manufacture the vaccine candidates in large quantities, the fact that the safety and efficacy of the vaccine candidates has not yet been established, the unknown ability of the vaccine candidates to generate revenue or profit for Applied DNA, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020, May 14, 2020 and August 6, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, [email protected]
Program contact: Brian Viscount, Applied DNA Sciences, 631-240-8877, [email protected]

Web:www.adnas.com

Twitter: @APDN

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Stem Cells Veterinary Biotechnology Pharmaceutical Health Infectious Diseases Genetics Clinical Trials

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Warrior Gold Announces $1 Million Private Placement

Warrior Gold Announces $1 Million Private Placement

Not for Distribution to United States Newswire Services or for Dissemination in the United States

TORONTO–(BUSINESS WIRE)–Warrior Gold Inc. (TSX-V – WAR) (“Warrior Gold” or the “Company”) is pleased to announce a non-brokered private placement to raise up to $1 million through the issuance of a combination of common share units (the “HD Units”) and flow-through share units (the “FT Units”) of the Company at a price of $0.09 per HD Unit and $0.12 per FT Unit (the “Private Placement”). Each Unit will comprise one common share, and in the case of the FT Units, one flow-through share, and one-half of one common share purchase warrant (each whole common share purchase warrant, a “Warrant”) with each Warrant entitling the holder to purchase one additional common share in the capital of the Company for a period of 18 months from the date of closing of the Private Placement, at a purchase price of $0.15 per common share, provided, however, that, if, at any time following the statutory four month hold period, the closing price of the common shares on the TSX Venture Exchange is greater than $0.20 for 20 or more consecutive trading days, the Warrants will be accelerated and will expire on the 30th business day following the date of such notice.

The Company may pay finder’s fees on a portion of the Private Placement in accordance with applicable securities laws and the policies of the TSX Venture Exchange. All securities issued under the Private Placement will be subject to a four month and one day “hold period” under applicable Canadian securities legislation.

The Private Placement is subject to approval of the TSX Venture Exchange.

The proceeds from the sale of the HD Units will be utilized by the Company for working capital and general corporate purposes and the proceeds from the sale of the FT Units will be used by the Company to incur eligible “Canadian exploration expenses” that will qualify as “flow-through mining expenditures” as such terms are defined in the Income Tax Act (Canada) (the “Qualifying Expenditures”) related to the Company’s Goodfish-Kirana Property located in Kirkland Lake, Ontario.

About Warrior Gold Inc.

Warrior Gold is a TSX Venture Exchange listed Company that owns the Goodfish-Kirana Property located five km from the town of Kirkland Lake, Ontario. The Property is located in the historic Kirkland Lake Gold Camp which is situated in the prolific Abitibi Greenstone Belt, recognized as one of the world’s highest grade greenstone belts with over 200 million ounces of gold produced to date.

The Goodfish-Kirana Property is 11.5 km long by roughly three km wide (34 km2) and contains three major structural trends: the east-west trending Kirana Deformation Zone; the northeast trending Goodfish Deformation Zone; and the Victoria Creek Deformation Zone on the recently acquired Sutton claims on the northeast side of the property. The Property contains numerous historical gold showings, as well as 18 historical pits and shafts.

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

Forward-Looking Statements: This press release contains forward-looking statements. Forward-looking statements are frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. The forward-looking statements are based on certain key expectations and assumptions made by the Company. Although Warrior Gold believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because Warrior Gold can give no assurance that they will prove to be correct. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. In addition to other risks that may affect the forward-looking statements in this press release are those set out in the Company’s management discussion and analysis of the financial condition and results of operations for the year ended March 31, 2020 and the second quarter ended September 30, 2020, which are available on the Company’s profile at www.sedar.com. The forward-looking statements contained in this press release are made as of the date hereof and Warrior Gold undertakes no obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

For additional information please contact:

Danièle Spethmann, P.Geo.

President & CEO

Warrior Gold Inc.

+1 647 344-3433

[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Natural Resources Other Natural Resources Mining/Minerals

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Sherritt Renews and Extends its $70 Million Credit Facility

Sherritt Renews and Extends its $70 Million Credit Facility

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

TORONTO–(BUSINESS WIRE)–
Sherritt International Corporation (“Sherritt” or “the Corporation”) (TSX:S), a world leader in the mining and refining of nickel and cobalt from lateritic ores, today announced that it has renewed and extended its $70 million credit facility with its syndicate of lenders to April 30, 2022. The renewal builds on the Corporation’s recently completed balance sheet initiative and related efforts to strengthen its capital structure and improve its liquidity.

“Combined with the recently completed balance sheet initiative and the purchase of put options, renewal of our $70 million credit facility provides us with increased financial strength and flexibility as we head into 2021,” said David Pathe, President and CEO of Sherritt International. “The renewal for an extended period coupled with more favorable covenants are indicative of our strengthened balance sheet and more encouraging outlook.”

Sherritt successfully maintained the size of the facility while extending the term beyond one year and agreeing to more flexible financial covenants. As at September 30, 2020, Sherritt had drawn approximately $8 million against the facility.

Interest on the credit facility will be based on bankers’ acceptance plus 400 basis points. The credit facility has a number of financial covenants, including:

  • Net available cash being greater than $25 million. This total is calculated as cash in Canada plus undrawn amounts on the credit facility.
  • Senior Secured Net Debt /EBITDA (earnings before interest, depreciation and amortization) of less than 2.0x. Senior secured net debt is calculated as first-lien debt, or amounts drawn on the credit facility, less cash held in Canada up to $25 million. EBITDA is calculated on a 12-month trailing basis with Energas included on a cash basis.
  • EBITDA/ Interest greater than 1.5x. The payment-in-kind (PIK) interest relating to the $75 million junior note offered as an additional consideration as part of the balance sheet initiative is excluded from this interest calculation.
  • Minimum Tangible Net Worth of $600 million plus 50% of future positive net income. Tangible net worth is total assets less intangible assets less total loans and borrowings.

As at September 30, 2020, Sherritt was in full compliance with the financial covenants of the amended credit facility.

The amended credit facility also includes an accordion feature that allows other lenders to join the syndicate pending appropriate approvals, and increase the size of the facility by $10 million to $80 million.

About Sherritt

Sherritt is a world leader in the mining and refining of nickel and cobalt from lateritic ores with projects and operations in Canada and Cuba. The Corporation is the largest independent energy producer in Cuba, with extensive oil and power operations across the island. Sherritt licenses its proprietary technologies and provides metallurgical services to mining and refining operations worldwide. The Corporation’s common shares are listed on the Toronto Stock Exchange under the symbol “S”.

Joe Racanelli, Director of Investor Relations

Telephone: 416-935-2457

Email: [email protected]

www.sherritt.com

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Natural Resources Other Natural Resources Mining/Minerals

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Deciphera Pharmaceuticals Completes Target Enrollment in the INTRIGUE Phase 3 Clinical Study of QINLOCK® (Ripretinib) in Patients with Second-Line Gastrointestinal Stromal Tumor

Deciphera Pharmaceuticals Completes Target Enrollment in the INTRIGUE Phase 3 Clinical Study of QINLOCK® (Ripretinib) in Patients with Second-Line Gastrointestinal Stromal Tumor

– Top-line Results Expected in Second Half of 2021 –

– Study Designed to Evaluate the Efficacy and Safety Profile of QINLOCK Compared to Sunitinib in Patients Previously Treated with Imatinib –

WALTHAM, Mass.–(BUSINESS WIRE)–
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the completion of its target enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK in patients with second-line gastrointestinal stromal tumor (GIST). QINLOCK, the Company’s switch-control tyrosine kinase inhibitor, is currently approved in the U.S., Canada, and Australia for patients with fourth-line GIST.

“We are pleased to announce the completion of target enrollment for our Phase 3 INTRIGUE study in patients with second-line GIST,” said Matthew L. Sherman, MD, Executive Vice President and Chief Medical Officer of Deciphera Pharmaceuticals. “This marks an important step forward to potentially bringing QINLOCK to an early-stage GIST population and establishing QINLOCK as the best-in-class treatment for this disease. We look forward to announcing top-line results for this study in the second half of 2021. I am grateful to the patients and their families, investigators, and our employees who have helped us reach this milestone.”

The INTRIGUE Phase 3 clinical study is a randomized, global, multicenter, open-label study to evaluate the efficacy and safety of QINLOCK compared to sunitinib in patients with GIST previously treated with imatinib. This study was designed to support regulatory approvals in second-line GIST patients in the United States, Europe, and other major markets. Approximately 426 patients were randomized 1:1 to either QINLOCK 150 mg once daily or sunitinib 50 mg once daily for four weeks followed by two weeks without sunitinib. The primary efficacy endpoint is median progression-free survival (mPFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR) and Overall Survival (OS). The study is being conducted at 122 investigational sites in 22 countries.

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.

QINLOCK is approved by the U.S. FDA for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. It is also approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.

About GIST

Gastrointestinal stromal tumor (GIST) is a cancer affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST is the most common sarcoma of the gastrointestinal tract, with approximately 4,000 to 6,000 new GIST cases each year in the United States and a similar incidence rate in European and other countries. Most cases of GIST are driven by a spectrum of mutations. The most common primary mutations are in KIT kinase, representing approximately 80% of cases, or in PDGFRA kinase, representing approximately 6% of cases. Current therapies are unable to inhibit the full spectrum of primary and secondary mutations, which drives resistance and disease progression. Estimates for 5-year survival range from 48% to 90%, depending on the stage of the disease at diagnosis.

About Deciphera Pharmaceuticals

Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK is Deciphera’s FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Canada and Australia. For more information, visit www.deciphera.com and follow us on LinkedIn and Twitter (@Deciphera).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations regarding timing for top-line data from our INTRIGUE study, the potential to bring QINLOCK to an early-stage GIST population and the potential to establish QINLOCK as the best-in-class treatment for this disease. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the severity and duration of the impact of COVID-19 on our business and operations, our ability to successfully demonstrate the efficacy and safety of our drug candidates and in additional indications for our existing drug, the preclinical or clinical results for our product candidates, which may not support further development of such product candidates, our ability to manage our reliance on sole-source third parties such as our third party drug substance and drug product contract manufacturers, actions of regulatory agencies, our ability to commercialize QINLOCK and execute on our marketing plans for any drugs or indications that may be approved in the future, the inherent uncertainty in estimates of patient populations, competition from other products, our ability to obtain and maintain reimbursement for any approved product and the extent to which patient assistance programs are utilized, our ability to comply with healthcare regulations and laws, our ability to obtain, maintain and enforce our intellectual property rights, any or all of which may affect the initiation, timing and progress of clinical studies and the timing of and our ability to obtain additional regulatory approvals, and other risks identified in our Securities and Exchange Commission (SEC) filings, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera, Deciphera Pharmaceuticals, and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.

Investor Relations:

Jen Robinson

Deciphera Pharmaceuticals, Inc

[email protected]

781-906-1112

Media:

David Rosen

Argot Partners

[email protected]

212-600-1902

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

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Verastem Oncology Initiates Phase 2 Registration-Directed Trial of VS-6766 and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

Verastem Oncology Initiates Phase 2 Registration-Directed Trial of VS-6766 and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

Previous Data from Investigator-Initiated Phase 1/2 Trial Show Encouraging Response Rates, Durability and a Favorable Safety Profile

Phase 2 Adaptive Trial Design to Evaluate VS-6766 Alone and in Combination with Defactinib

Verastem to Seek FDA Accelerated Approval, Pending Trial Outcome

BOSTON–(BUSINESS WIRE)–
Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced the initiation of a Phase 2 registration-directed clinical trial of VS-6766, its RAF/MEK inhibitor, and defactinib, its FAK inhibitor, in patients with recurrent low-grade serous ovarian cancer (LGSOC).

“Results to date have demonstrated the clinical activity of VS-6766 and defactinib in KRAS mutant cancers, signaling potentially promising clinical results in low-grade serous ovarian cancer and in KRAS-G12V mutant non-small cell lung cancer,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “The start of our registration-directed trial in recurrent LGSOC is a significant milestone in our work to develop the backbone of therapy for RAS driven tumors, an area of minimal therapeutic results, significant toxicity and limited treatment options.”

The Phase 2 study (GOG3052) is an adaptive two-part multicenter, parallel cohort, randomized, open label trial to evaluate the efficacy and safety of VS-6766 alone and in combination with defactinib in patients with recurrent LGSOC.1 The first part of the study will determine the optimal regimen of either VS-6766 monotherapy or in combination with defactinib in patients with recurrent LGSOC randomized 1:1 in each treatment arm. The determination of which regimen to take forward into the expansion phase of the trial will be made based on objective response rate data. The expansion phase of the study will examine efficacy and safety parameters of the regimen selected. Trial enrollment is underway in the United States with European sites to follow. Additional information about this study can be found here on ClinicalTrials.gov (NCT04625270). The Company previously announced its successful meeting with the Food and Drug Administration (FDA) in Q3 2020 and the FDA’s support of the Company’s development strategy and adaptive trial design for LGSOC.

According to Susana Banerjee, M.D., Ph.D., Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden and Team Leader at The Institute of Cancer Research, London, Global and Lead European Investigator of this trial, “Based on my experience treating patients with low-grade serous ovarian cancer in the Phase 1/2 FRAME trial, I have seen firsthand the potential for the combination of VS-6766 and defactinib, particularly in KRAS mutated tumors, which may address the significant limitations we have seen with other therapeutic approaches. This trial will further explore the encouraging response rates, durability and safety profile of VS-6766 and defactinib demonstrated in early phase studies and enable us to evaluate VS-6766 alone and in combination with defactinib to address the unmet needs of women with this specific type of ovarian cancer.”

“LGSOC is a difficult to treat disease most often diagnosed in women between the ages of 45 to 55 years.2 The majority of these patients experience a significant amount of pain and impact on their lives over a long period of time as response rates with current therapies have historically been low and the toxicity profiles of these agents make it difficult to keep patients on therapy,” said Rachel N. Grisham, M.D., Section Head, Ovarian Cancer and Director, Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center in Westchester, NY and the study’s principal US investigator. “This trial represents an opportunity to further evaluate the potential for improved outcomes for patients with LGSOC.”

The launch of the trial follows the recent results of two clinical trials led by Professor Udai Banerji, Deputy Director of Drug Development at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust. The first, a Phase 1 trial published in The Lancet Oncology, showed that VS-6766 could be effective against a range of KRAS-mutated tumor types, including lung and gynecological cancers.3 The second, a Phase 1/2 trial presented at the American Association for Cancer Research (AACR) Annual Meeting 2020, showed the combination of a RAF/MEK and FAK inhibitor could be beneficial for patients with KRAS mutant LGSOC.4

About Low Grade Serous Ovarian Cancer (LGSOC)

Low-grade serous ovarian cancer (LGSOC) is a recurrent, chemotherapy-resistant cancer with a high mortality rate.2 It comprises 5-10% of serous ovarian cancers and 6-8% of all ovarian cancers.2 There are an estimated 6,000 patients in the U.S. and 80,000 worldwide living with this disease.5 LGSOC is most often diagnosed in women between the ages of 45-55 years.2 LGSOC has a median survival of approximately 10 years,2 with 85% of patients experiencing recurrence6 and enduring severe pain and complications as the disease progresses. Chemotherapy is the standard of care for this disease.2

About VS-6766

VS-6766 is an oral small molecule inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors.

About Defactinib

Defactinib (VS-6063) is an oral small molecule inhibitor of FAK and PYK2 that is currently being evaluated as a potential combination therapy for various solid tumors. The Company has received Orphan Drug designation for defactinib in ovarian cancer in the US, EU and Australia. Preclinical research by Verastem Oncology scientists and collaborators at world-renowned research institutions has described the effect of FAK inhibition to enhance immune response by decreasing immuno-suppressive cells, increasing cytotoxic T cells, and reducing stromal density, which allows tumor-killing immune cells to enter the tumor.7,8

About the VS-6766/Defactinib Combination

RAS mutant tumors are present in ~30% of all human cancers, have historically presented a difficult treatment challenge and are often associated with significantly worse prognosis.9 Challenges associated with identifying new treatment options for these types of cancers include resistance to single agents, 10 identifying tolerable combination regimens with MEK inhibitors and new RAS inhibitors in development addressing only a minority of all RAS mutated cancers.

The combination of VS-6766 and defactinib has been found to be clinically active in patients with KRAS mutant tumors. In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with LGSOC, KRAS mutant NSCLC and colorectal cancer. Updated data from this study presented at the 2nd Annual RAS-Targeted Drug Development Summit in September 2020 demonstrated a 56% overall response rate and long duration of therapy among patients with KRAS-G12 mt LGSOC.10 Based on an observation of higher response rates seen in NSCLC patients with KRAS-G12V mutations in the study, Verastem will also be further exploring the role of VS-6766 and defactinib in KRAS-G12V NSCLC. The FRAME study was expanded in August 2020 to include new cohorts in pancreatic cancer, KRAS mutant endometrial cancer and KRAS-G12V NSCLC.

About Verastem Oncology

Verastem Oncology (Nasdaq: VSTM) is a development-stage biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition and focal adhesion kinase (FAK) inhibition. For more information, please visit www.verastem.com.

Forward-Looking Statements Notice

This press release includes forward-looking statements about Verastem Oncology’s strategy, future plans and prospects, including statements related to the potential clinical value of the RAF/MEK/FAK combination and the timing of commencing a registration-directed trial for the RAF/MEK/FAK combination. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “can,” “promising” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement.

Applicable risks and uncertainties include the risks and uncertainties, among other things, regarding: the success in the development and potential commercialization of our product candidates, including defactinib in combination with VS-6766; the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis or result in unmanageable safety profiles as compared to their levels of efficacy; our ability to obtain, maintain and enforce patent and other intellectual property protection for our product candidates; the scope, timing, and outcome of any legal proceedings; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of our product candidates; whether preclinical testing of our product candidates and preliminary or interim data from clinical trials will be predictive of the results or success of ongoing or later clinical trials; that the timing, scope and rate of reimbursement for our product candidates is uncertain; that third-party payors (including government agencies) may not reimburse; that there may be competitive developments affecting our product candidates; that data may not be available when expected; that enrollment of clinical trials may take longer than expected; that our product candidates will experience manufacturing or supply interruptions or failures; that we will be unable to successfully initiate or complete the clinical development and eventual commercialization of our product candidates; that the development and commercialization of our product candidates will take longer or cost more than planned; that we or Chugai Pharmaceutical Co., Ltd. will fail to fully perform under the VS-6766 license agreement; that we may not have sufficient cash to fund our contemplated operations; that we may be unable to make additional draws under our debt facility or obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity, debt financing or otherwise; that we will be unable to execute on our partnering strategies for defactinib in combination with VS-6766; that we will not pursue or submit regulatory filings for our product candidates; and that our product candidates will not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients.

Other risks and uncertainties include those identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-Q for the period ended September 30, 2020 as filed with the Securities and Exchange Commission (SEC) on November 9, 2020 and in any subsequent filings with the SEC. The forward-looking statements contained in this press release reflect Verastem Oncology’s views as of the date hereof, and the Company does not assume and specifically disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

References

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1 ClinicalTrials.gov. A Study of VS-6766 v. VS-6766 + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation. Available at: https://clinicaltrials.gov/ct2/show/NCT04625270?term=vs-6766&draw=2&rank=1. Accessed November 24, 2020.

2 Grisham, R. Low grade serous carcinoma of the ovary. Oncology. 2016. 30(7):650-652. Available at: https://www.cancernetwork.com/view/low-grade-serous-carcinoma-ovary. Accessed November 24, 2020.

3 Verastem Press Release. Verastem Oncology Announces New Data Published in The Lancet Oncology Supports Potential of VS-6766 as Treatment for RAS Mutant Tumors. October 28, 2020. Available at: https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-new-data-published-lancet-oncology. Accessed November 24, 2020.

4 Verastem Press Release. Verastem Oncology Announces Preliminary Data from Investigator-initiated Study Highlighting Clinical Activity of RAF/MEK and FAK Combination in KRAS Mutant Tumors Presented at the American Association for Cancer Research 2020 Virtual Annual Meeting. April 27, 2020. Available at: https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-preliminary-data-investigator. Accessed November 24, 2020.

5 Slomovitz, Gourley, Carey, Malpica, Shih, Huntsman, Fader., Grisham et al, Low-Grade serous ovarian cancer: State of the Science; Gynecol Oncol; 2020.

6 Corrado G, Salutari V, Palluzzi E, Distefano MG, Scambia G, Ferrandina G. Optimizing treatment in recurrent epithelial ovarian cancer. Expert Rev Anticancer Ther. 2017;17:1147-1158. doi: 10.1080/14737140.2017.1398088

7 Chénard-Poirier, M. et al. Results from the biomarker-driven basket trial of RO5126766 (CH5127566), a potent RAF/MEK inhibitor, in RAS- or RAF-mutated malignancies including multiple myeloma. Journal of Clinical Oncology 2017: 35. 10.1200/JCO.2017.35.15_suppl.2506.

8 ClinicalTrials.gov. Phase I Trial of VS-6063 and RO5126766. (FRAME). Available at: https://clinicaltrials.gov/ct2/show/NCT03875820. Accessed November 24, 2020.

9 Baines, A. T., Xu, D., & Der, C. J. (2011). Inhibition of Ras for cancer treatment: the search continues. Future medicinal chemistry, 3(14), 1787–1808. https://doi.org/10.4155/fmc.11.121

10 Verastem Press Release. Verastem Oncology Announces Presentation of Updated Phase 1/2 FRAME Study Data at the 2nd Annual RAS-Targeted Drug Development Summit. September 16, 2020. Available at: https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-presentation-updated-phase-12-frame. Accessed November 24, 2020.

 

Investors:

John Doyle

Vice President, Investor Relations & Finance

+1 781-469-1546

[email protected]

Media:

Lisa Buffington

Corporate Communications

+1 781-292-4205

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Oncology Health Clinical Trials General Health Pharmaceutical Biotechnology

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Piper Sandler Expands Public Finance Investment Banking with the Addition of Special District Group

Piper Sandler Expands Public Finance Investment Banking with the Addition of Special District Group

Sam Sharp, Zach Bishop and colleagues to join Piper Sandler

MINNEAPOLIS–(BUSINESS WIRE)–Piper Sandler Companies (NYSE: PIPR), a leading investment bank, is pleased to announce the addition of a special district group to its public finance investment banking business.

Sam Sharp and Zach Bishop will join the firm as managing directors for the special district group, bringing deep industry experience with a 20-year history of raising over $12B for infrastructure funding by special districts and tax increment authorities. Sharp will lead as head of the special district group. Sharp and Bishop built a market-leading presence in the Colorado metro district space, introduced a new market for special districts in Utah, and brought innovation to tax-increment financing in Kansas and Missouri.

Cory Johnson, Mike Ryan, Mike Sullivan and Shelby Turner will also be joining the special district group from D.A. Davidson & Co. as vice presidents. The team will be based in the firm’s Denver office and will report to Sharp.

“Piper Sandler’s commitment to our product, national platform, large institutional distribution capability and aligned vision made the firm a great fit for our team,” said Sam Sharp, head of special district group at Piper Sandler. “We are looking forward to partnering with the broader group at the firm and continuing to grow the business.”

“We are excited to welcome Sam, Zach and their colleagues to the firm,” said Frank Fairman, head of public finance at Piper Sandler. “With these additions, we have a market-leading team of 12 dedicated professionals in the special district area that is committed to our current markets and to expanding our special district footprint to better serve our clients in the years ahead.”

Sharp brings over 21 years of public finance investment banking experience. Prior to joining the firm, Sharp was a managing director and leader of the special district group at D.A. Davidson & Co. Sharp earned a bachelor’s degree in biology and politics from Occidental College and a Master of Business Administration from Columbia University. Prior to joining Piper Sandler, Bishop was a managing director in the special district group at D.A. Davidson Companies. Earlier in his career, he was a finance manager at General Electric. He earned a bachelor’s degree in business administration from Goshen College and a Master of Business Administration from Case Western Reserve University – Weatherhead School of Management.

ABOUT PIPER SANDLER

Piper Sandler Companies (NYSE: PIPR) is a leading investment bank and institutional securities firm driven to help clients Realize the Power of Partnership®. Securities brokerage and investment banking services are offered in the U.S. through Piper Sandler & Co., member SIPC and NYSE; in Europe through Piper Sandler Ltd., authorized and regulated by the U.K. Financial Conduct Authority; and in Hong Kong through Piper Sandler Hong Kong Limited, authorized and regulated by the Securities and Futures Commission. Private equity strategies and fixed income advisory services are offered through separately registered advisory affiliates.

©2020. Since 1895. Piper Sandler Companies. 800 Nicollet Mall, Minneapolis, Minnesota 55402-7036

Pamela Steensland

Tel: 612 303-8185

[email protected]

KEYWORDS: United States North America Minnesota

INDUSTRY KEYWORDS: Banking Professional Services Finance

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Mastercard, TSYS and Extend Launch Mobile Virtual Card Solution for Commercial Clients

Mastercard, TSYS and Extend Launch Mobile Virtual Card Solution for Commercial Clients

New solution enables commercial virtual cards to be seamlessly loaded into mobile wallets

PURCHASE, N.Y.–(BUSINESS WIRE)–
Mastercard and its partners, TSYS, a Global Payments company, and Extend, today introduced a mobile virtual card solution that enables virtual corporate cards to be easily loaded into a mobile wallet for fast and secure contactless payments.

The new mobile virtual card solution addresses the growing demand for digital, contactless commercial payments, which has been amplified by the changing nature of work and business expenses during the pandemic, and the rise of the work-from-home economy. Previously, one of the main barriers to wider adoption of virtual cards has been the inability to load them into a mobile wallet for use at physical point-of-sale terminals. With this new solution, employees or contractors can load their virtual corporate card into their mobile wallet to easily initiate contactless payments with their mobile device.

The solution uses Mastercard Digital Enablement Services (MDES) to tokenize virtual card numbers (VCNs) for secure mobile payments. MDES turns card numbers into tokens that become useless to fraudsters and eliminates the frustration of manually updating card numbers.

Businesses can use this solution to issue a single or multi-use virtual card to employees, enabling them to fund and manage authorized purchases. TSYS generates the virtual card number, which is accessed in the Extend app and then seamlessly loaded into a mobile wallet.

“Now, more than ever, companies are looking for flexible, virtual payment solutions,” said Ron Shultz, executive vice president, New Payments Business, North America at Mastercard. “By providing a truly virtual end-to-end solution for generating virtual commercial cards and taking them mobile, we’re helping businesses streamline their expense processes while providing employees with fast, simple and secure ways to pay.”

The new virtual card solution will:

  • Make paying with a mobile device easier: Users will be able to load the virtual card into their mobile wallet to easily pay with their mobile device for easy, secure transactions at contactless point-of-sale terminals.
  • Simplify issuing virtual cards: The program administrator can easily create and issue a virtual card to an employee or contractor via the Extend mobile app or web-based application.
  • Provide more control over spending: Companies will be able to easily set controls including specific time frames, amounts, and approved merchant categories.
  • Create new opportunities for issuing banks: Issuers are now able to offer mobile VCNs to their corporate clients for carded and non-carded employee use. They can also be instantly issued to an interview candidate for travel costs, or contract workers for the purchasing of supplies and materials.

Click on the link to learn how to use this new solution: https://www.paywithextend.com/app

Quote sheet

“This solution provides a more secure, reliable product that will help financial institutions and businesses streamline B2B payments by increasing their flexibility to pre-approve and manage transactions on a much more granular level than before,” said Gaylon Jowers, president, TSYS Issuer Solutions and senior executive vice president, Global Payments. “From new employee onboarding to last minute or first-time travels, our unique ability to tokenize the virtual account number, combined with the technology and innovation of Extend and Mastercard, opens up a multitude of new use cases for virtual cards in corporate payments.”

“Over the last several years we’ve seen a tremendous uptick in virtual card interest across the industry, but until now, they were irrelevant for in-store purchases,” said Andrew Jamison, CEO, Extend. “This partnership with TSYS and Mastercard has really eliminated the last thing holding virtual cards back from fully penetrating the market and showing us how much potential they really have.”

About Mastercard (NYSE: MA)

Mastercard is a global technology company in the payments industry. Our mission is to connect and power an inclusive, digital economy that benefits everyone, everywhere by making transactions safe, simple, smart and accessible. Using secure data and networks, partnerships and passion, our innovations and solutions help individuals, financial institutions, governments and businesses realize their greatest potential. Our decency quotient, or DQ, drives our culture and everything we do inside and outside of our company. With connections across more than 210 countries and territories, we are building a sustainable world that unlocks priceless possibilities for all. www.mastercard.com

About Global Payments

Global Payments Inc. (NYSE: GPN) is a leading pure play payments technology company delivering innovative software and services to our customers globally. Our technologies, services and employee expertise enable us to provide a broad range of solutions that allow our customers to operate their businesses more efficiently across a variety of channels around the world.

Headquartered in Georgia with nearly 24,000 employees worldwide, Global Payments is a member of the S&P 500 with worldwide reach spanning over 100 countries throughout North America, Europe, Asia Pacific and Latin America. For more information, visit www.globalpaymentsinc.com and follow Global Payments on Twitter (@globalpayinc), LinkedIn and Facebook.

About Extend

Extend Enterprises Inc, a Mastercard partner since joining the Mastercard Start Path program in 2018, builds digital payment infrastructure for trusted financial institutions to enable modern card experiences. Leading banks, businesses, and other innovators can now access the full power of virtual cards for their business, products, and clients. Extend’s core virtual card platform gives cardholders full power over the virtual card lifecycle via a sleek, easy-to-use web and mobile app, and a suite of normalized APIs across virtual card providers. Extend’s API Gateway offers a range of capabilities, including an industry-first tokenization service, and aims to facilitate streamlined partnership integrations between leading issuers and fintech service providers. Extend was founded in 2017 by industry veterans with decades of experience at Fortune 500 companies, including American Express and Capital One. For more information visit paywithextend.com LinkedIn.

Sandra Benjamin

+1 (416) 365-5567

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Banking Professional Services Finance

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WiSA’s First Branded Product, SoundSend, Now Available for WiSA Partners, Distributors and Retailers

WiSA’s First Branded Product, SoundSend, Now Available for WiSA Partners, Distributors and Retailers

SoundSend audio transmitter enables WiSA Certified™ speakers to instantly connect to Smart TVs, serves as a central device for seamless management of immersive home cinema media systems

SAN JOSE, Calif.–(BUSINESS WIRE)–WiSA® LLC, founded by Summit Wireless Technologies (NASDAQ: WISA), announced today that SoundSend, the Association’s first branded product, is now available at $179 US MSRP. Consumer Electronic brands can now offer audio enthusiasts smart surround sound 5.1 systems hard bundled with SoundSend or co-promote with premium audio speakers or TVs. Due to the expected high demand in its debut, WiSA partners are receiving the first product shipments before it is available in early December for individuals to purchase through Amazon, Newegg and other retailers. Consumers can expect Platin Audio to be the first WiSA member to deliver an all-in-one wireless audio system that includes SoundSend through its Tuned by THX™ Monaco 5.1 Immersive Wireless Home Audio System™.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201130005333/en/

WiSA SoundSend (Photo: Business Wire)

WiSA SoundSend (Photo: Business Wire)

“SoundSend opens a broad new market for speaker manufacturers to offer smart surround sound solutions with its low cost and simple setup,” said Tony Ostrom, President of WiSA. “Eliminating the need for A/V consoles, this small, impactful home cinema transmitter now enables the creation of immersive home theater experiences through a simple connection for all Smart TVs, a massive market for SoundSend. In addition, WiSA, with over 60 brand members, now has a significant and growing number of WiSA Certified home cinema speaker solutions. Premium audio brands like Klipsch, Bang & Olufsen, Bouchard, Harman and System Audio will be able to soft bundle with SoundSend at retail to offer consumers a high fidelity audio experience with a simple two-step connection.”

The SoundSend HDMI audio transmitter is designed to make true wireless multichannel audio accessible in minutes, without the need of WiFi, to any smart TV with ARC/eARC connections and transmits high-resolution audio automatically to WiSA Certified™ audio speakers for an immersive cinema experience at home. Transmitting high-quality 24-bit/96kHz audio for up to eight channels, SoundSend is the Association’s first product and offers advanced tuning features including My Zone to create the perfect sweet spot, and decoding capabilities for Dolby Digital, Dolby Digital+, Dolby TrueHD and Dolby Atmos.

SoundSend is branded and distributed by WiSA to ensure broad distribution worldwide for all WiSA members selling speakers. This groundbreaking solution guarantees interoperability for a variety of the world’s leading audio brands and further showcases WiSA’s commitment to implementing worldwide standards for wireless, high-resolution, multichannel audio.

About WiSA, LLC

WiSA®, the Wireless Speaker and Audio Association, is a consumer electronics consortium dedicated to creating interoperability standards utilized by leading brands and manufacturers to deliver immersive sound via intelligent devices. WiSA Certified™ components from any member brand can be combined to dramatically increase the enjoyment of movies and video, music, sports, gaming/esports, and more. WiSA also combines robust, high definition, multi-channel, low latency surround sound with the simple setup of a soundbar. For more information about WiSA, please visit: www.wisaassociation.org.

About Summit Wireless Technologies, Inc.

Summit Wireless Technologies, Inc. (NASDAQ: WISA) is a leading provider of immersive, wireless sound technology for intelligent devices and next generation home entertainment systems. Working with leading CE brands and manufacturers such as Harman International, a division of Samsung, LG Electronics, Klipsch, Bang & Olufsen, Xbox, a subsidiary of Microsoft, and others, Summit Wireless delivers seamless, dynamic audio experiences for high-definition content, including movies and video, music, sports, gaming/esports, and more. Summit Wireless is a founding member of WiSA, the Wireless Speaker and Audio Association and works in joint partnership to champion the most reliable interoperability standards across the audio industry. Summit Wireless, formerly named Summit Semiconductor, Inc., is headquartered in San Jose, CA with sales teams in Taiwan, China, Japan, and Korea. For more information about Summit Wireless Technologies, Inc., please visit: www.summitwireless.com.

* WiSA Ready TVs, gaming PCs and console systems are “ready” to transmit audio to WiSA Certified speakers when a WiSA USB Transmitter is plugged in and a user interface is activated through an APP or product design like LG TVs.

© 2020 Summit Wireless Technologies, Inc. All rights reserved. Summit Wireless Technologies and the Summit Wireless logo are trademarks of Summit Wireless Technologies, Inc. The WiSA logo, WiSA®, WiSA Ready™, and WiSA Certified™ are trademarks and certification marks of WiSA, LLC. Third-party trade names, trademarks and product names are the intellectual property of their respective owners.

Sarah Cox, Dittoe PR for WiSA, 765.546.1036, [email protected]

Keith Washo, WiSA Association, 984.349.272, [email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Technology Mobile/Wireless Audio/Video Consumer Electronics

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WiSA SoundSend (Photo: Business Wire)

Oak Street Health Announces Participation at Piper Sandler 32nd Annual Virtual Healthcare Conference

Oak Street Health Announces Participation at Piper Sandler 32nd Annual Virtual Healthcare Conference

CHICAGO–(BUSINESS WIRE)–
Oak Street Health, Inc. (NYSE: OSH), a network of value-based, primary care centers for adults on Medicare, today announced that the Company will be participating in the Piper Sandler Virtual 32nd Annual Healthcare Conference to be held December 1-3, 2020.

A webcast replay of the Company’s fireside chat is available on the “Events and Presentation” page of the Investors section of the Company’s website. The replay will remain available for 90 days following the event. For more information, please visit investors.oakstreethealth.com.

About Oak Street Health

Founded in 2012, Oak Street Health is a network of value-based, primary care centers for adults on Medicare. With a mission of rebuilding healthcare as it should be, the company operates an innovative healthcare model focused on quality of care over volume of services and assumes the full financial risk of its patients. Oak Street Health currently operates more than 70 centers across Illinois, Michigan, Ohio, Pennsylvania, Texas, Indiana, North Carolina, Rhode Island, Tennessee, New York and Mississippi. To learn more about Oak Street Health’s proven approach to care, visit oakstreethealth.com.

Source: Oak Street Health

Media:

Erica Frank

Vice President of Public Relations

(330) 990-5026

[email protected]

Investors:

Constantine Davides

(339) 970-2846

[email protected]

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: General Health Hospitals Health Professional Services Insurance

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Antibe Therapeutics Announces TSX Approval and Effective Date of Share Consolidation

Antibe Therapeutics Announces TSX Approval and Effective Date of Share Consolidation

TORONTO–(BUSINESS WIRE)–
Antibe Therapeutics Inc. (TSX: ATE, OTCQB: ATBPF), a clinical stage company leveraging its unique hydrogen sulfide platform to develop safer medicines for pain and inflammation, today announced that, further to a press release issued on November 17, 2020, the consolidation (“Consolidation”) of the Company’s issued and outstanding common shares (“Common Shares”) on the basis of ten (10) pre-consolidation Common Shares for one (1) post-Consolidation Common Share has been approved by the Toronto Stock Exchange (“TSX”). The Consolidation will be effective as of market open tomorrow, December 1, 2020.

Following the Consolidation, approximately 38,754,063 Common Shares will be issued and outstanding. As a result of the Consolidation, the Company’s outstanding warrants will be proportionately adjusted such that ten (10) warrants are now exercisable for one (1) post-Consolidation Common Share. The Company’s outstanding restricted share units and options will also be adjusted accordingly. The Company’s name and trading symbol will remain unchanged. The CUSIP number for the post-Consolidation Common Shares is 037025509.

About Antibe Therapeutics Inc.

Antibe is leveraging its proprietary hydrogen sulfide platform to develop next-generation, safer nonsteroidal anti-inflammatory drugs (“NSAIDs”) for pain and inflammation arising from a wide range of medical conditions. Antibe is developing three assets that seek to overcome the gastrointestinal (“GI”) ulcers and bleeding associated with NSAIDs. Antibe’s lead drug, otenaproxesul (ATB-346), is entering Phase III for osteoarthritis pain. Additional assets under development include a safer alternative to opioids for peri-operative pain, and a GI-safe alternative to low-dose aspirin. Learn more at antibethera.com.

Forward Looking Information

This news release includes certain forward-looking statements, which may include, but are not limited to, the proposed licensing and development of drugs and medical devices. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company’s inability to secure additional financing and licensing arrangements on reasonable terms, or at all, its inability to execute its business strategy and successfully compete in the market, and risks associated with drug and medical device development generally. Antibe Therapeutics assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.

Antibe Therapeutics Inc.

Christina Cameron

VP Investor Relations

+1 416-922-3460

[email protected]

Stern Investor Relations

Courtney Turiano

+1 212-362-1200

[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health

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