Author: [email protected]

Release – Onconova Therapeutics To Present At The Upcoming RHK Capital Disruptive Growth Conference

Posted on by [email protected]

Research, News, and Market Data on ONTX

Nov 28, 2022

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NEWTOWN, Pa., Nov. 28, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that it will participate in the RHK Capital Disruptive Growth Conference being held in the offices of Reed Smith in New York, NY on December 5-6, 2022. Mark Guerin, Chief Operating Officer & Chief Financial Officer, will present a corporate overview at the conference on Tuesday, December 6th at 11:20 a.m. ET.

To learn more or submit a registration request for the conference, visit http://disruptnyc.com/.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

For more information, please visit www.onconova.com.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
[email protected]

Release – Lineage Announces Launch of Phase 2a Study By Genentech Of Rg6501 (Opregen®) In Patients With Geographic Atrophy Secondary To Age-Related Macular Degeneration

Posted on by [email protected]

Research, News, and Market Data on LCTX

November 28, 2022 at 8:00 AM EST

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 28, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that its partner Genentech, a member of the Roche Group, has launched a Phase 2a, multicenter, open-label, single arm clinical study of RG6501 (OpRegen), a retinal pigment epithelial cell therapy. The study is intended to optimize subretinal surgical delivery and evaluate the safety and activity of OpRegen in approximately 30, and up to 60 patients with geographic atrophy (GA) secondary to age-related macular degeneration. The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by Optical Coherence Tomography (SD-OCT) imaging, within 3 months following surgery. RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech.

“In our Phase 1/2a clinical trial, RG6501 (OpRegen) demonstrated the potential to slow, stop, or reverse the progression of GA in patients with GA. These results can be maintained beyond one year following a one-time, approximately 30-minute outpatient procedure,” stated Brian M. Culley, Lineage CEO. “We are excited that Roche and Genentech are advancing the OpRegen program in a larger clinical study and will seek not only to optimize and potentially improve its delivery, but also confirm safety and activity of OpRegen in this patient population. We expect the findings from this Phase 2a study will be highly informative and may increase the probability of success in any future larger, comparative trials.”

“We are excited for the launch of this Phase 2a study, where one of the key objectives is to optimize the delivery of OpRegen to achieve the best outcomes,” stated Seppi Lin, Vice President of OMNI Early Clinical Development at Genentech. “This study will provide key insights for the future development of the OpRegen program. Geographic Atrophy (GA) secondary to AMD is a disease area of high unmet need with no approved therapies, and we are committed to developing effective and innovative medicines for patients with serious eye diseases.”

About the Phase 2a Study

The planned Phase 2a clinical study is a multicenter, open-label, single arm study to optimize subretinal surgical delivery and to evaluate the safety and activity of OpRegen in patients with GA secondary to AMD. Approximately 30 and up to 60 patients may be enrolled across multiple sites and will receive OpRegen administered as a single subretinal injection to one eye with impaired vision. Study treatment will consist of a single subretinal injection of OpRegen at a dose of up to approximately 200,000 cells delivered to target areas of GA in the study eye.

The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by SD-OCT imaging within 3 months following surgery.

About Geographic Atrophy

Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with GA.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: our collaboration and license agreement with Roche and Genentech and the timing of anticipated FDA interactions; the potential of RG6501 (OpRegen) to be a safe, effective and durable, one-time treatment for geographic atrophy secondary to age related macular degeneration; the significance of this Phase 2a study, including the potential that it will be informative or increase the potential of success in future larger, comparative trials; and preclinical activities, clinical trials, and clinical data updates related to our programs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221128005217/en/

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
([email protected])
(442) 287-8963

LifeSci Advisors
Daniel Ferry
([email protected])
(617) 430-7576

Russo Partners – Media Relations
Nic Johnson or David Schull
([email protected])
([email protected])
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Release – Ocugen To Present At 3rd Annual Dry AMD Therapeutics Summit

Posted on by [email protected]

Research, News, and Market Data on OCGN

November 28, 2022

MALVERN, Pa., Nov. 28, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Company’s Chief Scientific Officer, Arun Upadhyay, Ph.D., will participate in the 3rd Annual Dry AMD Therapeutics Summit at the Revere Hotel in Boston, Mass. from November 30-December 2, 2022.

“I am very pleased that Dr. Upadhyay will share more about our Modifier Gene Therapy platform—a novel approach to treating retinal diseases—during the Dry AMD Summit,” said Dr. Shankar Musunuri, Chairman, CEO & Co-Founder of Ocugen. “Our candidate, OCU410, is being developed to utilize the nuclear hormone receptor gene RORA for the treatment of dry AMD and we plan to file an IND application to initiate Phase 1/2 clinical trials in Q2 2023. We are enthusiastic about the potential for OCU410 to address unmet medical need in this category.”

Panel Discussion: Reviewing the Current State of Dry AMD Preclinical Models & What the Future Looks Like
Date: Wednesday, November 30, 2022
Time: 12:45 p.m. ET

Presentation: A Modifier Gene Therapy Approach for Treatment of Dry AMD
Date: Thursday, December 1, 2022
Time: 11:45 a.m. ET

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
[email protected]

Release – Sierra Metals Announces Appointment of Interim CEO

Posted on by [email protected]

Research, News, and Market Data on SMT

NOVEMBER 28, 2022

The Company will Host a Conference Call on Wednesday, November 30, 2022, at 8:30 AM EST

TORONTO–(BUSINESS WIRE)– Sierra Metals Inc. (TSX:SMT) (BVL:SMT) (“Sierra Metals” or the “Company”) announced today the resignation of Mr. Luis Marchese as the Chief Executive Officer and a Director of the Company, and the appointment, effective immediately, of Mr. Ernesto Balarezo Valdez as Interim Chief Executive Officer to lead the Company during its current strategic review process. Mr. Balarezo will also join the Board of Directors of the Company.

The previously announced strategic review process is ongoing under the direction of the Special Committee, comprised of the Company’s independent directors.

Mr. Oscar Cabrera, Chair of Sierra Metals’ Board of Directors stated, “On behalf of the Board, I would like to thank Luis for his commitment and service to Sierra Metals as CEO and Director, during a very challenging period for the Company. We wish him well in his future endeavours.”

He continued, “Sierra Metals’ Board is pleased that Mr. Balarezo has agreed to serve as the Company’s Interim CEO. His operations and leadership experience in the mining industry provides the right perspective and skills to lead the Company during the strategic review process.”

Mr. Balarezo’s career spans over three decades with extensive managerial and corporate experience at international and local levels with leading companies in the mining, cement and services industries, including as Executive Vice President for the Americas at Gold Fields Ltd. and as CEO of Gold Fields La Cima S.A. where he oversaw the Cerro Corona Mining unit in Peru. Mr. Balarezo’s mining experience also includes a broad range of positions with the Hochschild Group where he advanced to Vice President Operations after starting his tenure as General Manager of the Mexican branch and then as General Manager in Peru.

Mr. Balarezo holds a Bachelor of Science degree in Industrial Engineering and a Master of Science degree in Industrial Management from Texas A&M University. He has also completed the Management Development Program from the Universidad de Piura in Lima, Peru.

The Board has mandated Mr. Balarezo to focus on the safe, efficient, and responsible operation of the Company, with the objective of maximizing the value of the Sierra Metals business and assets.

Conference Call

The Company will host a conference call on Wednesday, November 30, 2022, regarding Mr. Balarezo’s appointment, at 8:30 am EST. Dial-in instructions are listed below:

Joining by Telephone:
Canada (Toll Free): 1 833 950 0062
Canada (Local): 1 226 828 7575

United States (Toll Free): 1 833 927 1758
United States (Local): 1 646 904 5544

United Kingdom (Toll Free): 44 808 189 6484

Access code: 022430

Press *1 to ask a question, *2 to withdraw your question, or *0 for operator assistance.

About Sierra Metals

Sierra Metals is a diversified Canadian mining company with Green Metal exposure including copper production and base metal production with precious metals byproduct credits, focused on the production and development of its Yauricocha Mine in Peru, and Bolivar and Cusi Mines in Mexico. The Company is focused on increasing production volume and growing mineral resources. The Company also has large land packages at all three mines with several prospective regional targets providing longer-term exploration upside and mineral resource growth potential.

For further information regarding Sierra Metals, please visit www.sierrametals.com or contact:

Continue to Follow, Like and Watch our progress:

Web: www.sierrametals.com | Twitter: sierrametals | Facebook: SierraMetalsInc |
LinkedIn: Sierra Metals IncInstagram: sierrametals

Investor Relations
Sierra Metals Inc.
Tel: +1 (416) 366-7777
Email: [email protected]

Source: Sierra Metals Inc.

Release – Filament Health Announces Psilocybin Supply Agreement With The Centre For Addiction And Mental Health

Posted on by [email protected]

Research News and Market Data on FLHLF

CAMH to use Filament’s natural psilocybin drug candidate for a clinical trial studying treatment-resistant depression

Vancouver, British Columbia, November 17, 2022 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament”or the “Company”), a clinical‐stage natural psychedelic drug development company, today announced an agreement with the Centre forAddiction and Mental Health (CAMH), Canada’s largest mental health teaching hospital and one of the world’s leading research centres in the field. Filament will supply CAMH with its natural psilocybin drug candidate for a proposed clinical trial studying the effects of psilocybin for treatment-resistant depression (TRD). The trial will be funded by the first ever Canadian federal grant to study psilocybin.

“Treatment-resistant depression affects millions of people and is a leading cause of disability worldwide, and current treatments are limited by either poor efficacy or tolerability,” said Dr. Ishrat Husain, the CAMH trial’s lead investigator. “Existing clinical data suggests that psilocybin shows promise for treating treatment-resistant depression; our intention is to expand on this research by examining whether psychedelic effects are necessary to achieve an antidepressant response. The trial design relies upon a supply of safe, high quality psilocybin so Filament Health’s support is crucial to our success.”

Treatment-resistant depression (TRD)affects up to a third of all depressed individuals, and results in substantial functional decline and high mortality rates.Current treatment options for TRD, can have either inadequate efficacy, adverse effects, or are difficult to access. With this trial, CAMH intends to determine whether psychedelic-assisted psychotherapy with psilocybin is a viable alternative treatment, and whether psychedelic effects are necessary for efficacy.

“CAMH is one of the world’s most well-regarded mental health research institutions,” said Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. “We’re proud to donate our natural psilocybin drug candidate to support this vital research.It’s another important step in our mission of getting safe, natural psychedelics into the hands of everyone who needs them, as soon as possible.

The clinical trial application is under review by Health Canada with approval anticipated by January 2023.

ABOUT FILAMENT HEALTH (OTCQB:FLHLF)(NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn.

MEDIA RELATIONS

Anna Cordon, Director of Communications778.245.9067

[email protected]‍

INVESTOR RELATIONS

[email protected]

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward‐looking statements” and “forward‐looking information,” respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, “expect”,“anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”,“intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements.Forward‐looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information, including status of patent applications and the ability to secure patents.There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward‐ looking statements and forward‐looking information. Filament will not update any forward‐ looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws.

Release – FAT Brands Inc. to Present at the Benchmark Company’s Upcoming Discovery One-on-One Investor Conference

Posted on by [email protected]

Research, News, and Market Data on FAT

NOVEMBER 23, 2022

LOS ANGELES, Nov. 23, 2022 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT), a leading global franchising company and parent company of iconic brands including Round Table Pizza, Fatburger, Johnny Rockets, Twin Peaks, Fazoli’s and 12 other restaurant concepts, today announced their participation in the Benchmark Company’s 11th Annual Discovery One-on-One Investor Conference on Thursday, December 1, 2022 at the New York Athletic Club in New York City.

FAT Brands is scheduled to participate in one-on-one meetings with institutional analysts and investors throughout the day. The conference offers emerging growth and dynamic publicly traded companies access to institutional and individual investors in a unique one-on-one format.

To schedule a one-on-one meeting with FAT Brands, you may submit your request online via the link provided upon registration. To register for the conference, please visit https://www.benchmarkcompany.com/news-events/upcoming-events/the-11th-annual-discovery-one-on-one-investor-conference.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

About The Benchmark Company

The Benchmark Company is an institutionally focused, research driven, sales trading and investment banking firm. We were founded in 1988 and are headquartered in New York City. Our focus is on fostering the long-term success of our corporate clients through raising capital, providing strategic advisory services, generating insightful research and developing institutional sponsorship by leveraging the firm’s sales, trading and equity research capabilities. https://www.benchmarkcompany.com.

Investor Relations:
ICR
Michelle Michalski
[email protected]
646-277-1224

Media Relations:

Erin Mandzik
[email protected]
860-212-6509

Release – Tonix Pharmaceuticals to Participate in the A.G.P. Biotech Conference

Posted on by [email protected]

Research, News, and Market Data on TNXP

November 23, 2022 7:00am EST

CHATHAM, N.J., Nov. 23, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that management will participate virtually in the A.G.P. Biotech Conference and host investor meetings. The conference is being held Wednesday, November 30, 2022 – Thursday, December 1, 2022.

Investors interested in arranging a meeting with the Company’s management during the conference should contact the conference coordinator or Ian Frost at [email protected].

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
[email protected]
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
[email protected]
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released November 23, 2022

Release – Schwazze Opens An Additional Cannabis Dispensary In New Mexico Located In Sunland Park; Brings Total R.Greenleaf Store Count To 13

Posted on by [email protected]

Research, News, and Market Data on SHWZ

November 23, 2022

                                                                                                                  NEO: SHWZ
OTCQX: SHWZ

Grand Opening Event Scheduled for Wednesday, November 23rd

DENVER, Colo., Nov. 23, 2022 /CNW/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), a premier vertically integrated, multi-state operating cannabis company with assets in Colorado and New Mexico, announces the grand opening of its adult-use dispensary, R.Greenleaf, located in Sunland Park, New Mexico. The new store, located at 1541 Appaloosa Drive in Sunland Park, officially opened its doors for business on November 22nd. Thanksgiving Day the store will be open from 10a to 4p. Regular store operating hours are 8a to 10p Monday through Saturday; 8a to 8p on Sunday.

The Sunland Park store opening continues the intentional expansion throughout the state of New Mexico and comes on the heels of the store openings in Ruidoso and Clovis within the last 60 days. This brings R.Greenleaf’s number of New Mexico retail dispensaries to a total of 13. All locations serve the needs of medical patients as well as recreational adult-use consumers.

“This week in particular, Schwazze gives tremendous thanks to be contributing to the Sunland Park community and to serve its residents. We are very grateful to add our third R.Greenleaf retail dispensary in New Mexico within the last two months and since adult recreational cannabis was legalized in New Mexico on April 1st,” said Steve Pear, New Mexico Division President for Schwazze. “R.Greenleaf offers a wide variety of quality products serviced by top-notch, knowledgeable staff.”

Grand opening product specials and promotions are already in full swing with multiple flower pack offers, pre-rolls, gummies, chocolates, and distillate vaporizer cartridges. Introductory pricing will be offered through November 30th to provide patients and recreational customers special savings on a variety of product forms based on individual needs and preferences.

A grand opening celebration will be held today, Wednesday, November 23rd beginning at 12 noon and running until 6p. Swag bags will be available to the first 50 shoppers featuring a water bottle, rolling papers and other R.Greenleaf gear, with one lucky customer receiving a 50% discount coupon. DJ Sonya G will be on site during the event to provide tunes for all in attendance, and the Sunland Park BBQ Company will provide free food for the first 50 customers making a purchase.

Sunland Park Store Location
R.Greenleaf
1541 Appaloosa Drive
Sunland Park, New Mexico 88063

Grand Opening Celebration
Wednesday, November 23rd
12 noon to 6p

Since April 2020, Schwazze has acquired, opened or announced the planned acquisition of 38 cannabis retail dispensaries as well as seven cultivation facilities and two manufacturing plants in Colorado and New Mexico. In May 2021, Schwazze announced its Biosciences division and in August 2021 it commenced home delivery services in Colorado.

About Schwazze

Schwazze (OTCQX: SHWZ)  (NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to consummate the acquisition described in this press release or to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses, including the acquisition described in this press release, and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, and (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

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SOURCE Schwazze

Release – Alvopetro Announces 183-B1 Agua Grande Formation Test Results

Posted on by [email protected]

Research, News, and Market Data on ALVOF

Nov 22, 2022

CALGARY, AB, Nov. 22, 2022 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces initial results from the second interval tested in our 183-B1 well on our 100% owned and operated Block 183.

In July 2022, we completed drilling the 183-B1 exploration well to a total measured depth (“MD”) of 2,917 metres. Based on open-hole wireline logs and fluid samples confirming hydrocarbons, the well discovered hydrocarbons in multiple formations with a total of 34.3 metres of potential net hydrocarbon pay, with an average porosity of 10.6% and average water saturation of 29.0% using a 6% porosity cut-off, 50% Vshale cut-off and 50% water saturation cut-off.

Alvopetro has completed the 183-B1 formation test in the Agua Grande formation, the second deepest of three formations with hydrocarbons shows during drilling of the well. We perforated a total of 8.5 metres in the Agua Grande formation at various intervals between 2,680 metres and 2,699 metres MD. During the clean up flow period we recovered 16 bbls of completion fluid and 1 bbl of 52°API natural gas liquids (condensate).   After a short shut-in we initiated the production test on a 32/64″ choke. Cumulatively, over the duration of the 72-hour production test, we recovered 2.4 bbls of 48°API natural gas liquids (condensate), 9.4 bbls of formation water and 2.4 MMcf of gas. During the test, the flowing rate decreased from 5.7 MMcfpd to 0.3 MMcfpd, the average gas rate during testing operations was 0.8 MMcfpd.  At the beginning of the testing operations the shut-in wellhead pressure (“SIWHP”) was 2,555 psi, and the final flowing wellhead pressure was 40 psi.  After 32 hours of buildup the SIWHP was 610 psi.

These results indicate a high permeability zone that delivered strong initial production flow rates but, based on pressure and production declines over the flow period, and slow pressure build up following the test, the Agua Grande reservoir appears to be areally constrained in the high permeability zone and likely sub-commercial in the remaining Agua Grande zones. We will now proceed up-hole to test the Candeias Formation.  Based on open-hole logs, using a 6% porosity cut-off, 50% Vshale cut-off and 50% water saturation cut-off the Gomo member of the Candeias Formation was encountered at 2,578 to 2,583 metres total vertical depth, with 5.3 metres of potential net light oil pay, at an average 35.0% water saturation and average porosity of 15.7%.  A fluid sample in this Candeias interval was also collected with a dual packer wireline tool recovering 37.1°API oil with no water to surface from 2,580 metres depth at a formation pressure of 4,317 psi.

We previously announced the results of the 183-B1 formation test in the Sergi Formation, the deepest of three formations with hydrocarbons shows during drilling of the well. We perforated a total of 26.5 metres in the upper portion of the Sergi formation at various intervals between 2,811 metres MD and 2,886 metres MD. We initially swabbed 63 bbls of oil and 7 bbls of completions fluid during the clean-up period. After a short shut-in we then initiated the production test. Cumulatively, over the duration of the 72-hour production test, we recovered 59 bbls of 43°API oil, 7 bbls of water identified as completion fluid, and 0.28 MMcf of associated gas. The daily oil rate recovered during swabbing operations averaged 20 bopd.  We are engineering a stimulation plan for this upper Sergi section in this well and we have submitted applications to drill two follow up wells from this 183-B1 surface location targeting the full Sergi hydrocarbon column and the potential in the deeper Boipeba Formation.

Corporate Presentation

Alvopetro’s updated corporate presentation is available on our website at:http://www.alvopetro.com/corporate-presentation. 

Social Media

Follow Alvopetro on our social media channels at the following links:Twitter – https://twitter.com/AlvopetroEnergyInstagram – https://www.instagram.com/alvopetro/LinkedIn – https://www.linkedin.com/company/alvopetro-energy-ltd YouTube – https://www.youtube.com/channel/UCgDn_igrQgdlj-maR6fWB0w

Alvopetro Energy Ltd.’s vision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.

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 news release.

All amounts contained in this new release are in United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.

Abbreviations:

API  =American Petroleum Institute
°API  =an indication of the specific gravity of crude oil measured on the API gravity scale.
bbls=barrels
boepd=barrels of oil equivalent (“boe”) per day
bopd=barrels of oil and/or natural gas liquids (condensate) per day
MMcf  =million cubic feet
MMcfpd=million cubic feet per day

BOE Disclosure. The term barrels of oil equivalent (“boe”) may be misleading, particularly if used in isolation. A boe conversion ratio of six thousand cubic feet per barrel (6Mcf/bbl) of natural gas to barrels of oil equivalence is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. All boe conversions in this news release are derived from converting gas to oil in the ratio mix of six thousand cubic feet of gas to one barrel of oil.

Testing and Well Results. Data obtained from the 183-B1 well identified in this press release, including hydrocarbon shows, open-hole logging, net pay and porosities and initial testing data, should be considered to be preliminary until detailed pressure transient and other analysis and interpretation has been completed. Hydrocarbon shows can be seen during the drilling of a well in numerous circumstances and do not necessarily indicate a commercial discovery or the presence of commercial hydrocarbons in a well. There is no representation by Alvopetro that the data relating to the 183-B1 well contained in this press release is necessarily indicative of long-term performance or ultimate recovery. The reader is cautioned not to unduly rely on such data as such data may not be indicative of future performance of the well or of expected production or operational results for Alvopetro in the future.

Forward-Looking Statements and Cautionary Language. This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward‐looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning potential hydrocarbon pay in the 183-B1 well, exploration and development prospects of Alvopetro and the expected timing of certain of Alvopetro’s testing and operational activities. The forward‐looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning testing results of the 183-B1 well and the 182-C2 well, equipment availability, the timing of regulatory licenses and approvals, the success of future drilling, completion, testing, recompletion and development activities, the outlook for commodity markets and ability to access capital markets, the impact of the COVID-19 pandemic, the performance of producing wells and reservoirs, well development and operating performance, foreign exchange rates, general economic and business conditions, weather and access to drilling locations, the availability and cost of labour and services, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR profile at www.sedar.com. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

SOURCE Alvopetro Energy Ltd.

Release – Tonix Pharmaceuticals Announces Oral Presentation at the World Vaccine and Immunotherapy Congress

Posted on by [email protected]

Research, News, and Market Data on TNXP

November 22, 2022 7:00am EST

CHATHAM, N.J., Nov. 22, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will deliver an oral presentation at the World Vaccine and Immunotherapy Congress 2022, which will be held in San Diego, Calif., November 28 – December 1, 2022. A copy of the Company’s presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the World Vaccine and Immunotherapy Congress website here. 

Oral Presentation Details
Title:Showcase 1: Early Development of Smallpox & Monkey Pox Vaccines
Location:Loews Coronado Bay Resort, San Diego, Calif.
Date:December 1, 2022
Time:10:40 a.m. PT (1:40 p.m. ET)
  

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
[email protected]
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
[email protected]
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released November 22, 2022

Release – PDS Biotech Executives to Present an Overview of Oncology and Infectious Disease Programs at the World Vaccine & Immunotherapy Congress

Posted on by [email protected]

Research, News, and Market Data on PDSB

Chief Medical Officer, Dr. Lauren V. Wood, to present on the development of targeted immunotherapies for solid tumors based on the Versamune® platform

Dr. Siva Gandhapudi, Director of Immunology Product Development, to present on development of a universal flu vaccine based on the Infectimune™ platform

FLORHAM PARK, N.J., Nov. 21, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced two executives will be giving presentations at the World Vaccine & Immunotherapy Congress, which will take place from November 28 through December 1, 2022, in San Diego.

PDS Biotech speakers at the conference include:

SpeakerTimeSubject
Dr. Lauren V. Wood,
Chief Medical Officer		Tuesday, Nov. 29, 4:50 p.m. Pacific TimeDevelopment of targeted immunotherapies for solid tumors based on the Versamune® platform
Dr. Siva Gandhapudi, Director of Immunology Product DevelopmentWednesday, Nov. 30, 2:30 p.m. Pacific TimeDevelopment of a universal flu vaccine based on the InfectimuneTM platform

More than 800 attendees are expected to attend the World Vaccine & Immunotherapy Congress to examine challenges around scientific, commercial, public health and policy issues in manufacturing, clinical trials, regulation, immune profiling, biomarkers, platform technologies, and additional topics.

“We welcome the opportunity to highlight the Versamune® and Infectimune™ platforms and their potential to address significant unmet medical needs to the biotechnology and scientific community,” said Dr. Frank Bedu-Addo, PDS Biotech President and CEO. “We are looking forward to advancing our product development in both oncology and infectious disease, ultimately to improve patient care.”

About Versamune®

Current immunotherapies have demonstrated an ability to treat certain cancers, but limitations with their effectiveness persist. Versamune® is a novel investigational T cell activating platform designed to stimulate a precise immune system response to cancer-specific proteins. PDS Biotech is advancing multiple Versamune® based clinical and pre-clinical programs with its lead clinical candidate – PDS0101 – targeting HPV-positive cancers.

About InfectimuneTM

Infectimune™ is a novel proprietary investigational T cell immune activating platform technology designed to train the immune system to better protect against disease. The Infectimune™ platform stimulates the immune system to recognize the pathogen and induce potent killer T cell and memory T cell response for long-term protection safely with no clinically relevant toxicities.

About PDS Biotechnology 

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements 

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0202 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0202 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. 

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology. 

Investor Contacts: 
Deanne Randolph 
PDS Biotech 
Phone: +1 (908) 517-3613 
Email: [email protected] 

Rich Cockrell 
CG Capital 
Phone: +1 (404) 736-3838 
Email: [email protected]

Media Contacts: 
Dave Schemelia 
Tiberend Strategic Advisors, Inc.
Phone: +1 (609) 468-9325 
Email: [email protected] 

Bill Borden 
Tiberend Strategic Advisors, Inc.
Phone: +1 (732) 910-1620 
Email: [email protected] 

Release – Tonix Pharmaceuticals Announces Oral Presentation at the World Antiviral Congress

Posted on by [email protected]

Research News and Market Data on TNXP

November 21, 2022 7:00am EST

CHATHAM, N.J., Nov. 21, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will deliver an oral presentation at the World Antiviral Congress 2022, which will be held in San Diego, Calif., November 28 – December 1, 2022. A copy of the presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the World Antiviral Congress website here.

Oral Presentation Details

Title:Development of fully human monoclonal antibodies against SARS-CoV2 using peripheral B-cells from COVID-19 survivors 
Location:Loews Coronado Bay Resort, San Diego, Calif.
Date:November 30, 2022
Time:12:40 p.m. PT (3:40 p.m. ET)

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
[email protected]
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
[email protected]
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released November 21, 2022

Release – Harte Hanks to Present at the Benchmark Company’s Discovery Conference

Posted on by [email protected]

Research, News, and Market Data on HHS

CHELMSFORD, MA / ACCESSWIRE / November 17, 2022 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company, today announced that Brian Linscott, Harte Hanks’ Chief Executive Officer, will be presenting at the Benchmark Company’s 11th Annual Discovery One-on-One Investor Conference to be held Thursday, December 1, 2022 at the New York Athletic Club in New York City.

Harte Hanks is scheduled to participate in one-on-one meetings with institutional analysts and investors throughout the day.

To schedule a one-on-one meeting with Harte Hanks, you may submit your request online via the link provided upon registration. To register for the conference, please visit https://www.benchmarkcompany.com/news-events/upcoming-events/the-11th-annual-discovery-one-on-one-investor-conference

About Harte Hanks

Harte Hanks (Nasdaq: HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract, and engage their customers.

Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea, Sony and IBM, among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.

For more information, visit hartehanks.com

As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks.

Investor Relations Contact:

FNK IR
Rob Fink or Tom Baumann
(646) 809-4048 / (646) 349-6641
[email protected]

SOURCE: Harte Hanks, Inc.

View source version on accesswire.com:
https://www.accesswire.com/726700/Harte-Hanks-to-Present-at-the-Benchmark-Companys-Discovery-Conference