PDA India Chapter Annual Meeting – Maintaining Quality & Compliance in Pharmaceutical Drug Manufacturing and Regulatory Expectations – Being Held March 11-15, in Hyderabad, India

PDA India Chapter Annual Meeting – Maintaining Quality & Compliance in Pharmaceutical Drug Manufacturing and Regulatory Expectations – Being Held March 11-15, in Hyderabad, India




PDA India Chapter Annual Meeting – Maintaining Quality & Compliance in Pharmaceutical Drug Manufacturing and Regulatory Expectations – Being Held March 11-15, in Hyderabad, India

PQE Group to Sponsor, Present Technical Content Exhibit, and Attend Conference

HYDERABAD, India–(BUSINESS WIRE)–PQE Group is excited to join the 2024 PDA India Chapter Annual Meeting in Hyderabad from March 11-15, focusing on key issues in the pharmaceutical and medical device industries.


The conference will cover environmental monitoring, aseptic processing, cleaning validation, cross-contamination, and compliance strategies in the pharma and medical device industries, with insights from regulators and experts on technologies, data integrity, and quality enhancement.

On the first day of the conference, the opening plenary sessions will feature opening remarks from Dr. Sarah McMullen, Country Director, US FDA India Office, Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA/FDA, Dr. Anil Sawant, Senior Vice President, Global Quality Compliance, Merck Sharpe & Dohme, USA and Chair, Board of Directors, PDA Inc, a Regulatory Update will be provided by Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter and many other exciting regulatory presenters. Annual Meeting Day One will also focus on Quality Culture, with sessions including topics regarding several aspects of the importance of Quality Culture, Quality Sustainability, and Quality Maturity, which will be led by presenters including Dr. Rosa, Dr. G.K. Raju, Chairman and CEO, Light Pharma Inc., Stephen Tyrpak, Vice President Operations, PQE US Inc, and Dr. Deva Puranam, Head – Global Quality Investigations, Surveillance & Regulatory Communications, Viatris.

The “Back to Basics” workshop on March 14-15, hosted by US FDA and industry experts, will discuss key regulations and guidelines to help participants understand regulatory expectations for sustainable operations. In addition, Stephen Tyrpak will lead sessions on Quality Culture, risk management, and visual inspections with case studies and demos. FDA and EDQM regulators, along with other experts, will conduct various sessions throughout the conference.

“We’re thrilled to take part, present, and support this significant event, which has become increasingly valuable for the pharmaceutical and medical device industries in India. Since PQE Group’s launch in India in 2019, we’ve grown to over 110 professionals dedicated to compliance across the region. We eagerly anticipate a productive and educational week in Hyderabad, looking forward to reconnecting with peers and forging new partnerships at booth #7.” said Mahesh Jagtap, PQE India local partner.

Contacts

Media Contact:

Debra Kaufmann – d.kaufmann@pqegroup.com; +1.240.704.0550

Ibogaine By David Dardashti Announces Breakthrough Algorithm to Quantify Quantum Electrodynamics

Ibogaine By David Dardashti Announces Breakthrough Algorithm to Quantify Quantum Electrodynamics




Ibogaine By David Dardashti Announces Breakthrough Algorithm to Quantify Quantum Electrodynamics

Unlocking a Comprehensive Understanding of the Electric Force

MIAMI, March 03, 2024 (GLOBE NEWSWIRE) — Ibogaine By David Dardashti, a leading technology platform, is pleased to announce the successful development of an algorithm which revolutionizes the way quantum electrodynamics is quantified.

Quantum Emotions The Algorithm eliminates a matrix approach which was previously used, and instead accounts for electric fields formulated from triangular forces at each angle, as well as the impact of the earths rotation on these forces at each radius of convergence in time. Utilizing the principles of a power series involving triple integrals and higher derivatives to efficiently account for the electric field in exactly 11 dimensions, the algorithm provides an unprecedented accuracy. When asked about the impact of the algorithm, Gavriel Dardashti, Scientist at Ibogaine By David Dardashti, stated: “By Understanding the impact of quantum mechanics on our emotions, a journey through the subsconcious infiltrates the space time continuum offering new insights which shed light on quantum physics.” Ibogaine By David Dardashti recognizes the potential for accelerated growth of glial cells new insights generated by the algorithm, and is proud to have been part of the cutting edge research and development in this field.

Ibogaine By David Dardashti is proud to have been part of the cutting edge research and development of the algorithm which utilizes the principles of a power series and higher derivatives to account accurately for quantum emotions in 11 dimensions.

Ibogaine By David Dardashti plans to move forward in making sure that this breakthrough algorithm becomes a household name for its ability to augment the understanding of Quantum Electrodynamics.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e13e14b0-f2f2-4b61-8094-dd33564c00e9

CONTACT: Gavriel Dardashti
+17869301880
gavriel@ibogaineclinic.com

Ibogaine by David Dardashti Creates Innovative Algorithm for Fentanyl Treatment

Ibogaine by David Dardashti Creates Innovative Algorithm for Fentanyl Treatment




Ibogaine by David Dardashti Creates Innovative Algorithm for Fentanyl Treatment

BOSTON, March 03, 2024 (GLOBE NEWSWIRE) — For those struggling with fentanyl addiction, Ibogaine by David Dardashti is revolutionizing the way the deadly opiate is treated.

Fentanyl Treatment

Ibogaine by David Dardashti has developed an optimized algorithm for fentanyl treatment that takes into account the individual’s prior use of the drug and any associated potency. This algorithm also accounts for any other drugs that the individual may be consuming, addressing drug interactions with opiates in a proactive manner. “By utilizing implicit differentiation, our algorithm is tailored specifically to the needs of each patient,” said David Dardashti. “This method allows us to adjust the algorithm based on the observations of previous operations, while taking into consideration the other substances the patient may be taking.” The algorithm adds additional days of treatment for those who are currently taking or who have recently taken fentanyl in combination with other opiates.

The algorithm has been designed to account for any potential future opiate use, and any associated potency, by using the same core components but adjusting one variable at a time. This innovative method is being used to drastically reduce the accessibility of and dependence on fentanyl, and to minimize the physical and psychological side effects associated with the highly potent drug. Ibogaine by David Dardashti hopes that this breakthrough algorithm will revolutionize drug treatment around the world.

For more information on Ibogaine by David Dardashti and their optimized algorithm for fentanyl treatment, please visit their website at www.ibogaineclinic.com.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b7abca26-6c5c-4482-b8b4-54b299e0283a

Ibogaine By David Dardashti Visits Ohio to Explore Economic Benefits

Ibogaine By David Dardashti Visits Ohio to Explore Economic Benefits




Ibogaine By David Dardashti Visits Ohio to Explore Economic Benefits

Organization Visits Ohio to Learn of the Benefits of Legalizing Ibogaine for Opiate Addiction

BOSTON, March 03, 2024 (GLOBE NEWSWIRE) — Ibogaine By David Dardashti, an organization focusing on providing ibogaine treatment to those afflicted with opiate addiction, recently visited Ohio to explore the potential economic benefits if the state were to legalize the substance.

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“Ibogaine Legislation” Led by David Dardashti, a successful real estate entrepreneur since his 26th year, and Chief Operations Officer Cole Barressi, Ibogaine By David Dardashti flew out to Cleveland to discuss potential opportunities that would arise if the state of Ohio were to pass ibogaine legislation. With the housing market in Cleveland becoming increasingly inexpensive, this could prove to be a great opportunity for those in recovery as housing in the area is much more accessible for those of limited financial means. “Our dream is to one day provide ibogaine treatment to people of all socioeconomic classes,” said Barressi. “No one wanting to break an addiction should have to endure the pain of opiate withdrawal.” Ibogaine By David Dardashti has seen success with other states, and has been pushing for legalization for many years. The organization is hopeful that Ohio will become the first state to legalize ibogaine for medical use in the United States.

Ibogaine By David Dardashti is advocating for the legalization of ibogaine in Ohio in order to provide seamless access to treatment for all people, regardless of socioeconomic status.

Ibogaine By David Dardashti encourages those suffering from opiate addiction to speak to their lawmakers and voice their support for the legalization of ibogaine in the state of Ohio.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bbfa5397-d8a8-40bb-8b80-189efa08f74f

CONTACT: Cole Barressi
1-800-818-4511
cole.bl@ibogaineclinic.com

Scilex Holding Company Announces that the Official Committee of Unsecured Creditors of Sorrento Therapeutics, Inc., has Filed a Motion with the U.S. Bankruptcy Court to Extend the Lockup Period on Shares of Scilex Stock Previously Distributed by Sorrento to its Stockholders as a Dividend from March 31, 2024 to September 30, 2024

Scilex Holding Company Announces that the Official Committee of Unsecured Creditors of Sorrento Therapeutics, Inc., has Filed a Motion with the U.S. Bankruptcy Court to Extend the Lockup Period on Shares of Scilex Stock Previously Distributed by Sorrento to its Stockholders as a Dividend from March 31, 2024 to September 30, 2024




Scilex Holding Company Announces that the Official Committee of Unsecured Creditors of Sorrento Therapeutics, Inc., has Filed a Motion with the U.S. Bankruptcy Court to Extend the Lockup Period on Shares of Scilex Stock Previously Distributed by Sorrento to its Stockholders as a Dividend from March 31, 2024 to September 30, 2024

PALO ALTO, Calif., March 02, 2024 (GLOBE NEWSWIRE) — Scilex Holding Company (Nasdaq: SCLX, “Scilex”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that the Official Committee of Unsecured Creditors (the “Creditors’ Committee”) of Sorrento Therapeutics, Inc. (OTC: SRNEQ, “Sorrento”) has filed a motion (the “Motion”) with the U.S. Bankruptcy Court for the Southern District of Texas (the “Court”) seeking to further extend the restrictions on transfer on the shares of common stock of Scilex that were previously distributed by Sorrento to its stockholders as a dividend on January 19, 2023 (the “Dividend Stock”) from March 31, 2024 to September 30, 2024. Further notice related to the U.S. Bankruptcy Court’s decision on the Motion will be communicated once an order has been granted.

Accordingly, as described in the Motion, if the Court approves the Motion, any shares of the Dividend Stock (including any such shares held by brokerage firms) may not be sold, transferred or otherwise disposed of and the holders of Dividend Stock would be prohibited from causing or encouraging any third party to do the same. If approved, this extension shall apply only to the Dividend Stock and does not apply to any other outstanding securities of Scilex.

To review the Motion, please click the link here.

About Scilex Holding Company

Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes.    Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) GLOPERBA®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults, expected to launch in 2024.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica for which Scilex has completed a Phase 3 study; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022 and a Phase 2 clinical trial is expected to commence in 2024.

Scilex Holding Company is headquartered in Palo Alto, California.

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the potential for the Court to refuse to grant the Motion, Scilex’s plans to launch GLOPERBA in 2024 and plans to initiate a Phase 2 clinical trial in 2024 for SP-104.  

Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law.

Contacts:

Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310

Email: investorrelations@scilexholding.com 

Website: www.scilexholding.com

SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.

Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

ELYXYB® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

All other trademarks are the property of their respective owners.

© 2024 Scilex Holding Company All Rights Reserved.

Ultimovacs announces publication of results from NIPU Phase II trial with UV1 vaccination in mesothelioma in European Journal of Cancer

Ultimovacs announces publication of results from NIPU Phase II trial with UV1 vaccination in mesothelioma in European Journal of Cancer




Ultimovacs announces publication of results from NIPU Phase II trial with UV1 vaccination in mesothelioma in European Journal of Cancer

NON-REGULATORY PRESS RELEASE

  • The NIPU trial is investigating the effect of adding UV1 vaccine to immunotherapy as second-line treatment of pleural mesothelioma. The results were initially presented at the ESMO Conference in October 2023
  • The publication outlines the full trial results, including observations on UV1’s positive impact on objective response rate, overall survival, and additional data on increased efficacy in defined histological subtypes

Oslo, March 2, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announced that the results from the randomized controlled Phase II clinical trial, NIPU, are published in the European Journal of Cancer. The trial investigates the effect of adding Ultimovacs’ cancer vaccine UV1 to second-line treatment with ipilimumab and nivolumab for patients with pleural mesothelioma (NCT04300244).

NIPU is an investigator-initiated, open-label, multi-center Phase II trial sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs. Six university hospitals in Australia, Denmark, Norway, Spain, and Sweden participated in the trial. 118 patients were randomized between June 2020 and January 2023.

The study did not meet its primary endpoint of improved progression-free survival (PFS) based on blinded independent central review (BICR). Analyses on the secondary endpoints, objective response rate (ORR) by BICR and overall survival (OS), showed a significant benefit of adding the UV1 vaccine to ipilimumab and nivolumab. Local assessment demonstrated an improved PFS among patients in the vaccine arm for all histological subtypes combined, and new subgroup analysis demonstrates further improvement for the epithelioid subtype. The epithelioid subtype represents approximately 70% of all patients with mesothelioma.

The safety profile of the combination of UV1 plus ipilimumab and nivolumab observed in the trial was consistent with that of ipilimumab and nivolumab alone, confirming the good safety profile for the UV1 vaccine.

==ENDS==

About Ultimovacs

Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine candidate UV1 is directed against human telomerase (hTERT), an antigen present in 85-90% of cancers in all stages of tumor growth. A broad clinical program, with Phase II trials in five cancer indications enrolling more than 670 patients, aims to demonstrate UV1’s impact in combination with other immunotherapies in multiple cancer types expressing telomerase and where patients have unmet medical needs. UV1 is universal, off-the-shelf, and easy to use. UV1 is a patented technology owned by Ultimovacs.

In addition, Ultimovacs holds all rights to the proprietary TET technology platform for any possible future formulations for the treatment of solid tumor indications. The Company is listed on the Euronext Oslo Stock Exchange (OSE: ULTI). 

About NIPU
NIPU (Nivolumab and Ipilimumab Plus/minus UV1 vaccination) is a randomized, multi-center phase II trial in which Ultimovacs’ universal cancer vaccine, UV1, is evaluated in combination with Bristol-Myers Squibb’s checkpoint inhibitors, nivolumab and ipilimumab, as second-line treatment of malignant pleural mesothelioma. The trial sponsor is Oslo University Hospital, supported in the preparation and execution of the trial by Ultimovacs and Bristol Myers Squibb. The 118 patients are randomized 1:1 into two treatment arms. All participants receive treatment with nivolumab (240 mg every 2 weeks) and ipilimumab (1 mg/kg every 6 weeks) until disease progression, unacceptable toxicity or for a maximum of 2 years. Patients randomized to the experimental arm received 8 intradermal injections of UV1 vaccine during the first three months of treatment. The objective of the study is to achieve a clinically meaningful progression-free survival (PFS) benefit in patients with malignant pleural mesothelioma (MPM) after progression on first-line standard platinum doublet chemotherapy. Subsequent events emerging in patients in both arms of the NIPU study will continue to be monitored beyond the read-out of the primary endpoint. The ipilimumab and nivolumab combination has recently been approved as first-line treatment for patients with malignant pleural mesothelioma in Europe and the U.S.


About Mesothelioma

Malignant pleural mesothelioma is a rare and aggressive type of cancer that occurs in the thin layer of tissue that surrounds the lungs and inside of the chest. Mesothelioma accounted for 30 870 new cancer cases and 26 278 cancer deaths worldwide in 2020, according to International Agency for Research on Cancer (Globocan 2020). Pleural mesothelioma is a disease with a high unmet medical need, especially in industrialized countries. The median overall survival is approximately 1 year.  Occupational asbestos exposure is the No. 1 cause of the disease, and several occupations like firefighters, military veterans, construction, and industry workers, are at risk. This cancer usually takes several decades to develop after a person’s first exposure to asbestos. Most patients are diagnosed after age 70 because of the long latency period. Even though the use of asbestos to a large extent is banned in many countries today, new incidences of mesothelioma will continue to be a medical and public health challenge because of the long latency period typical of the illness. For patients with inoperable disease, few treatment options are available after first-line chemotherapy. The combination of ipilimumab and nivolumab has recently shown increased survival compared to standard chemotherapy, but most patients do not respond, and improvements are called for. Telomerase is expressed in mesothelioma cells and is therefore a relevant target for therapeutic vaccination.

About UV1

UV1 is a universal cancer vaccine designed to induce a specific T-cell response against telomerase. UV1 consists of long, synthetic peptides representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to induce CD4+ T-cells. These CD4+ T-cells have the potential to provide inflammatory signals, and T-cell support is believed to be critical for triggering a strong anti-tumor immune response. Following intradermal injection, antigen-presenting cells (APCs) in the skin are exposed to the vaccine peptides. These APCs will process the peptides and present vaccine epitopes on Human Leukocyte Antigen (HLA) molecules to naïve T-cells in the lymph nodes. Activated vaccine-specific T-cells will then enter the circulation and search for cells displaying their cognate antigen in the context of HLA molecules.

The UV1 peptides contain several epitopes, shown to be non-restrictive in terms of (HLA) alleles for presentation. It is, therefore, not required to perform HLA pre-screening of patients, which potentially enables broad population utilization of the vaccine. UV1 is administered over three months with eight intradermal injections and the immune-modulator GM-CSF.

For further information, please see www.ultimovacs.com or contact:

Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Anne Worsøe, Head of Investor Relations
Email: anne.worsoe@ultimovacs.com
Phone: +47 90686815

This stock exchange announcement was published by Anne Worsøe, Head at Investor Relations at Ultimovacs ASA, on March 2, 2024 at 18:40 CET. 

 

Malaysia Healthcare Travel Council Denies Allegations of Lack Of Direction in the Company

Malaysia Healthcare Travel Council Denies Allegations of Lack Of Direction in the Company




Malaysia Healthcare Travel Council Denies Allegations of Lack Of Direction in the Company

KUALA LUMPUR, Malaysia, March 02, 2024 (GLOBE NEWSWIRE) — Malaysia Healthcare Travel Council (MHTC) would like to refer to the news published by a local news organisation titled – “Malaysia Healthcare Travel Council in ‘serious’ condition with massive resignations, ‘lack of direction’”.

MHTC has made significant strides in advancing agency-wide operational excellence which has been crucial to strengthening its foundation and positioning the agency for its next growth phase. MHTC is evolving to meet the needs of healthcare travellers globally. We have already set out the strategies for Malaysia Year of Medical Tourism 2026 programme and are already working with the various government agencies and stakeholders to ensure the success of the programme. As we transition, we are committed to identifying additional opportunities to drive improved returns for our partners and stakeholders, and making healthcare travel a key export for the country.

To learn more about Malaysia Healthcare and its services, please visit https://malaysiahealthcare.org or visit our social feeds at: www.facebook.com/MHTCMalaysia or at LinkedIn (Malaysia Healthcare Travel Council).

For media enquiries:

Chandrika Bhaskaran
Senior Manager
PR & Communications
Malaysia Healthcare Travel Council
chandrika.b@mhtc.org.my
Falliq Effendy
Manager
PR & Communications
Malaysia Healthcare Travel Council
m.falliq@mhtc.org.my
   

ABOUT THE MALAYSIA HEALTHCARE TRAVEL COUNCIL

The Malaysia Healthcare Travel Council (MHTC) is a government agency under the Ministry of Health Malaysia that has been entrusted with the responsibility of curating the country’s healthcare travel scene, making it a key export service industry. Founded in 2009, MHTC works to streamline industry players and service providers in facilitating and growing Malaysia’s healthcare travel industry under the brand “Malaysia Healthcare” with the intended goal of making Malaysia the leading global healthcare destination. MHTC works closely with over 90 private healthcare facilities in Malaysia, who are registered members of MHTC.

Adial Pharmaceuticals Announces Exercise of Warrants for $3.5 Million Gross Proceeds

Adial Pharmaceuticals Announces Exercise of Warrants for $3.5 Million Gross Proceeds




Adial Pharmaceuticals Announces Exercise of Warrants for $3.5 Million Gross Proceeds

CHARLOTTESVILLE, Va., March 01, 2024 (GLOBE NEWSWIRE) — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 1,150,000 shares of common stock of the Company originally issued in October 2023, having an exercise price of $2.82 per share and eighteen months term. The shares of common stock issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form S-1 (No. 333-275397). The gross proceeds to the Company from the exercise of the warrants are expected to be $3,530,500, prior to deducting placement agent fees and estimated offering expenses.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash and the payment of $0.125 per new warrant, the Company will issue new unregistered warrants to purchase up to 2,300,000 shares of common stock. The new warrants will have an exercise price of $2.82 per share, will be immediately exercisable upon issuance and will have a term of eighteen months from the issuance date.

The offering is expected to close on or about March 6, 2024, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds for general corporate purposes, including general and administrative expenses, working capital and to support regulatory and clinical activities related to AD04, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD).

The new warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the new warrants issued in the private placement and the shares of common stock underlying the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

About Adial Pharmaceuticals, Inc.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated to be approximately one-third of the AUD population) identified using the Company’s companion diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.

Forward-Looking Statements

This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include without limitation, statements regarding the closing of the private placement, the satisfaction of the closing conditions of the private placement, and the use of net proceeds from the private placement as well as the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, market and other conditions, our ability to pursue our regulatory strategy, our ability to maintain our Nasdaq listing, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to retain our key employees or maintain our Nasdaq listing, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2022, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

Investor Contact

Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: adil@crescendo-ir.com

Bristol Myers Squibb Announces Dividend

Bristol Myers Squibb Announces Dividend




Bristol Myers Squibb Announces Dividend

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that its Board of Directors has declared a quarterly dividend of sixty cents ($0.60) per share on the $0.10 par value common stock of the company. The dividend is payable on May 1, 2024, to stockholders of record at the close of business on April 5, 2024.


In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable on June 3, 2024, to stockholders of record at the close of business on May 7, 2024.

About Bristol Myers Squibb Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

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Contacts

Media:
media@bms.com

Investors:
investor.relations@bms.com

Oragenics Announces Closing of Public Offering

Oragenics Announces Closing of Public Offering




Oragenics Announces Closing of Public Offering

SARASOTA, Fla.–(BUSINESS WIRE)–Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a company focused on developing unique, intranasal nanoparticle pharmaceuticals for the treatment of neurological disorders, today announced the closing of its previously announced underwritten public offering of 1,400,000 shares of its common stock at a public offering price of $1.50 per share, for gross proceeds of $2.1 million, before deducting underwriting discounts, and offering expenses payable by the Company. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 210,000 shares of its common stock at the public offering price, less discounts, to cover over-allotments, if any.


The Company intends to use the net proceeds from the offering to fund the continued development of ONP-002, which is a unique neurosteroid drug compound intended to treat mild traumatic brain injuries also known as concussions, and for general corporate purposes and working capital.

ThinkEquity and Laidlaw & Company (UK) Ltd. acted as joint book-running managers for the offering.

The offering is being made pursuant to an effective shelf registration statement that has been filed with the U.S. Securities and Exchange Commission (the “SEC”). The final prospectus supplement relating to the offering was filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Oragenics

Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com.

Forward Looking Statements

This press release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms and similar expressions intended to identify forward-looking statements. These statements include statements related to the intended use of proceeds. The Company cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, risks related to prevailing market conditions, the impact of general economic, industry or political conditions in the United States, and the Company’s ability to satisfy customary closing conditions associated with the offering. Forward-looking statements reflect its analysis only on their stated date, and the Company undertakes no obligation to update or revise these statements except as may be required by law.

Contacts

Oragenics, Inc.
Janet Huffman, Chief Financial Officer

813-286-7900

jhuffman@oragenics.com