BioSig Strengthens Marketing and Sales Teams, Appoints National Account Executives to Scale Commercial Growth

News and Market Data on BioSig Technologies

August 30, 2022

Westport, CT, Aug. 30, 2022 (GLOBE NEWSWIRE) —

• Company increases sales
  efforts and strategy, adds new National Account Executives to accelerate
  commercial growth

• Strengthens marketing
  team with new marketing and communications programs highlighting
  competitive market advantage

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today announced that it has expanded its marketing and sales teams to scale and support the national commercial rollout of its PURE EP™ System.

BioSig recently doubled the size of its sales organization, with plans of tripling it before the fourth quarter of this year. The Company appointed a new team of National Account Executives who will be strategically located throughout the U.S. to support and accelerate sales growth and adoption of the PURE EP™ System. The new sales executives will expand the Company’s growing commercial pipeline, as it continues to see an increase in medical centers entering into 60-day evaluation agreements for its novel signal processing technology.

Additionally, BioSig has expanded its marketing team, with investment in top-tier industry talent that will help drive and enhance the Company’s brand equity and awareness to better reflect the Company’s values. These new efforts include a fully integrated marketing and communications strategy that will support the commercial team and should provide the tools to increase BioSig’s competitive position in the market.  

“As a growing enterprise, we are dedicated to sourcing, developing, and retaining the best talent for our company. I view our recent investment in our commercial, sales, and marketing teams as a complimentary catalyst for BioSig’s new commercial strategy and longterm growth. We are thrilled to have attracted these outstanding industry leaders, and look forward to leveraging their wealth of knowledge and expertise,” said Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.

About
BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System, is a novel signal processing and acquisition platform designed to extract advanced diagnostic and therapeutic data that enhances physician workflow and increases throughput. PURE EP™ was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights. The Company is in a national commercial launch of the PURE EP™ System. The technology is in regular use in some of the country’s leading centers of excellence, including Mayo Clinic, and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.

Clinical data acquired by the PURE EP™ System in a multi-center study at centers of excellence including Texas Cardiac Arrhythmia Institute at St. David’s Medical Center  was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(T.M.) signals over conventional sources.

Forward-looking
Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future 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 and consequently, actual 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) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. 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.

Andrew Ballou

BioSig Technologies, Inc.

Vice President, Investor Relations

55 Greens Farms Road

Westport, CT 06880

[email protected]

203-409-5444, x133

Source: BioSig Technologies, Inc.

Released
August 30, 2022

Baudax Bio Announces Pricing of $6.2 Million Public Offering

Research, News, and Market Data on Baudax Bio

August 29, 2022 10:04pm EDT

MALVERN, Pa., Aug. 29, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the pricing of its public offering of an aggregate of 11,819,172 shares of its common stock (or pre-funded warrants in lieu thereof), together with accompanying common stock purchase warrants, at a public offering price of $0.525 per share (or pre-funded warrant) and accompanying warrants. Each share of common stock (or pre-funded warrant) was sold in the offering together with a Series A-1 warrant to purchase one share of common stock at an exercise price of $0.525 per share and a Series A-2 warrant to purchase one share of common stock at an exercise price of $0.525 per share. The Series A-1 warrants are exercisable immediately and will expire five years from the date of issuance, and the Series A-2 warrants are exercisable immediately and will expire thirteen months from the date of issuance. The closing of the offering is expected to occur on or about September 1, 2022, subject to the satisfaction of customary closing conditions.

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

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $6.2 million. The Company intends to use the net proceeds from this offering for pipeline development activities and general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-266499), which was declared effective by the Securities and Exchange Commission (the “SEC”) on August 29, 2022. The offering is being made only by means of a prospectus which is a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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 offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About
Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO®, the first and only 24-hour, non-opioid, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO®, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs.

Forward
Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. Forward-looking statements may include, without limitation, statements regarding market conditions, the satisfaction of the closing conditions of the offering and the use of net proceeds from the offering. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

Investor Relations Contact:
Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
[email protected]  

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected] 

Source: Baudax Bio, Inc.

Released
August 29, 2022

Image Credit: Cottonbro (Pexels)

Psilocybin-Assisted Psychotherapy vs. Placebo in the Treatment of Adult Patients With Alcohol Use Disorder

“Psilocybin administered in combination with psychotherapy produced robust decreases in the percentage of heavy drinking days compared with those produced by active placebo and psychotherapy.” This is the result of a study designed to see if the ingredient in “magic mushrooms,” coupled with therapy, curbs drinking in adults with alcohol use disorder. The study, published in JAMA Psychiatry, said drinking was curbed for at least eight months, and nearly half the participants receiving psilocybin stopped drinking entirely. 

Introduction

Psilocybin and other classic psychedelics to treat neuropsychiatric conditions have been experiencing a resurgence in study not seen since the 1960s. Alcohol use disorder (AUD) is considered a particularly promising target for treatment with psychedelics. Six clinical trials published between 1966 and 1971 demonstrated that participants with alcohol dependence treated with lysergic acid diethylamide (LSD) showed signs of remission during follow-up nearly twice as often as those not treated. Picking up on this line of research, after more than 40 years, a study published in 2015 demonstrated that moderately high doses of psilocybin (21 to 28 mg/70 kg) were well tolerated by participants with alcohol dependence, and large reductions in drinking were observed over a 32-week follow-up period.

Offering additional proof-of-concept, a multisite randomized clinical trial evaluated the efficacy of psilocybin-assisted psychotherapy for the treatment of AUD. The outcomes of the double-blind trial were reported on August 24 in a peer-reviewed journal for clinicians; highlights of the study appear to confirm earlier studies.

Method of Study

Men and women, 93 in all, between the ages of 25 and 65, that were being treated for AUD participated in the multiyear study. Roughly half of the participants took one psilocybin pill, followed by another a month later. The remaining participants served as a control group and were unknowingly administered a placebo (Benadryl).

Prior to the first medication/placebo dose, participants had up to a dozen counseling sessions given by a pair of psychotherapists. The therapists worked to help the participants set objectives to minimize their alcoholic drinks and to help them navigate what could be very emotional psilocybin experiences.

The study was originally designed to randomize up to 180 participants. However, following an indefinite mandatory suspension of recruitment beginning on March 19, 2020, due to the outbreak of COVID-19, enrollment for this trial was halted at 95 randomized participants.

Participants

Participants were recruited from March 12, 2014, to May 13, 2015, at the University of New Mexico and from July 9, 2015, to March 19, 2020, at New York University, using advertisements in local media. The 25 to 65-year-olds had a diagnosis of alcohol dependence determined by the Structured Clinical Interview and had at least four heavy drinking days during the 30 days prior to screening (defined as five or more drinks in a day for a man and four or more drinks in a day for a woman). Excluded were those with major psychiatric and drug use disorders, any hallucinogen use in the past year or more than 25 lifetime uses, medical conditions that contraindicated either of the study medications, use of exclusionary medications, and current treatment for AUD.

Trial Design

Qualifying participants were assessed at screening, baseline (week 0), and weeks 4, 5, 8, 9, 12, 24, and 36. They were randomly assigned to receive either psilocybin or Benadryl (diphenhydramine), administered in two 8-hour sessions at weeks 4 and 8. All participants who completed the double-blind observation period (weeks 5 to 36) and still met safety criteria were offered an open-label psilocybin session at week 38, including four additional psychotherapy sessions and assessment for an additional 18 weeks.

Participants received up to a total of $560 for completing assessments in the course of the trial but were not reimbursed for attending the therapy and medication sessions.

Randomization and Blinding

Randomization was stratified by site. A study pharmacist at each site generated the randomization sequence and assigned treatment in order of randomization. All other study staff and investigators, as well as participants, were blind to treatment assignment.

Image: Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder (JAMA Network

Dosage

Study medication was taken orally in a single capsule of unvarying appearance and weight. Psilocybin doses were weight-based to control for participant body weight. Doses for the first session were psilocybin, 25 mg/70 kg, or diphenhydramine, 50 mg. Participants received an increased dose in the second session if there were no dose-limiting adverse events and if they agreed to the increase. The increased dose of psilocybin was 30 mg/70 kg if the participant’s total score on the Pahnke-Richards Mystical Experience Questionnaire (MEQ)42 was 0.6 or greater in the first session (indicating a robust subjective response to the 25 mg/70 kg dose) or 40 mg/70 kg if the MEQ total score in the first session was less than 0.6. The increased dose of diphenhydramine was 100 mg regardless of subjective response.

Administration of Study Medication

Psilocybin was administered in the morning; participants were required to stay in the session room with the therapists for at least 8 hours after. During the session, participants were encouraged to lie on a couch wearing eyeshades and headphones, providing a standardized playlist of music. Other medications were available in the session room to treat hypertension, severe anxiety, or psychotic symptoms as specified in the protocol.

Blood pressure and heart rate were measured at 30- to 60-minute intervals during the first 6 hours of each session. After each, participants and therapists were asked to guess which medication had been administered and rate their degree of certainty on a 100-point visual analog scale (0?=?not at all confident; 100?=?extremely confident). This uncovered a flaw in the study as Benadryl was ineffective in maintaining the blind intention after drug administration, so biased expectancies could have influenced results.

Outcome

The primary alcohol consumption outcome was measured as the percentage of heavy drinking days during weeks 5 to 32. Drinking was assessed at weeks 8, 12, 24, and 36 using the timeline follow-back method. One standard drink was defined as 14 g of ethanol. Secondary outcomes included the percentage of drinking days, mean drinks per day, and dichotomous outcomes. Hair or fingernail samples were collected at week 24 and assayed for ethyl glucuronide (EtG) concentration to confirm self-reported abstinence.

There were 204 reported adverse events (119 in the psilocybin group and 85 in the Benadryl group) during the 32 weeks following the first administration of the study medications. Three serious adverse events were reported, all in the Benadryl group. One participant had two psychiatric admissions due to suicidal ideation during binge drinking episodes. Another participant was hospitalized for a Mallory-Weiss tear due to severe vomiting during a binge drinking episode.

Psilocybin in the US

There is a growing cry to take psychedelics medically mainstream. The federal government appears to be moving forward to unwind some strict prohibitions on psychedelic research. In May, the Substance Abuse and Mental Health Services Administration released a letter saying that the agency now agrees that psychedelics hold promise in psychiatric care. It is exploring the creation of a task force to assess how the medicines could be used safely in clinical settings.

In the U.S. nearly 15 million people age 12 or older have AUD, according to the 2019 National Survey on Drug Use and Health.

Take Away

Participants suffering from problem drinking were given psilocybin along with psychotherapy. The result of the study medication was a robust and sustained decrease in drinking. These results support further study of psilocybin-assisted treatment for adults with AUD.

A recent NobleCon investor event featured a panel presentation with representatives of related fields discussing both regulatory reform and the results of their treatments and studies. There were also panel presentations from the management of companies providing promising treatments from once taboo sources. Click on links below (Suggested Content) to watch these presentations.

Paul Hoffman

Managing Editor, Channelchek

Suggested Content

PsyBio Therapeutics (PSYBF) NobleCon18 Presentation Replay

Psyched Wellness (PSYCF) NobleCon18 Presentation Replay

Wesana Health (WSNAF) NobleCon18 Presentation Replay

Mental Wellness: Psychedelics? NobleCon18, Panel Replay

Sources

JAMA
Clinical trial Protocol

https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2795625

https://www.wsj.com/articles/psychedelic-compound-in-magic-mushrooms-shows-new-promise-as-alcohol-addiction-treatment-11661354909?mod=Searchresults_pos1&page=1

https://cde.drugabuse.gov/instrument/d89c8e23-16e5-625a-e040-bb89ad43465d

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BioSig Places Second PURE EP™ System For Evaluation at Cleveland Clinic a Leading Medical Center of Excellence

News and Market Data on BioSig Technologies

August 24, 2022

Westport, CT, Aug. 24, 2022 (GLOBE NEWSWIRE) —

• Leading Medical Center
  of Excellence adds second PURE EP™ System for evaluation, broadening
  physician access to the Company’s signal processing technology

• PURE EP™ is now being
  evaluated at both Main and Fairview campuses of Cleveland Clinic’s Heart,
  Vascular & Thoracic Institute 

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today announced that it has installed a second evaluation system at the Cleveland Clinic. The additional installation will support the medical center’s clinical evaluation of the PURE EP™ System and expand physician access to the Company’s signal processing technology. 

“I am pleased to see the growing interest and demand for our technology at The Cleveland Clinic. The additional unit will enable more physicians the opportunity to experience the superior signal quality of the PURE EP™ System on a broad range of cases.” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.

Consistent with its stated national commercial strategy, the Company’s customer-centered approach aims to maximize the clinical value and deployment of the PURE EP™ System which has gained interest in several electrophysiology labs in the Midwest. The Company recently expanded its clinical footprint in Illinois with an additional evaluation agreement at a leading medical center in Springfield, the state capital.

Looking ahead, BioSig will serve as a partner at the upcoming Cleveland Clinic Global EP Summit 2022, due to take place this coming September. This annual forum convenes over 40 global experts and highlights the latest practice insights across the spectrum of electrophysiology care.

About
Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. As a leader in arrhythmia treatment and diagnosis, Cleveland Clinic medical centers include state-of-the-art electrophysiology laboratories, world-class physicians and researchers, and the latest cutting-edge technologies and protocols deployed for the treatment of heart abnormalities. To learn more, visit clevelandclinic.org.

About
BioSig Technologies

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System, is a novel signal processing and acquisition platform designed to extract advanced diagnostic and therapeutic data that enhances physician workflow and increases throughput. PURE EP™ was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights. The Company is in a national commercial launch of the PURE EP™ System. The technology is in regular use in some of the country’s leading centers of excellence, including Mayo Clinic, and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.

Clinical data acquired by the PURE EP™ System in a multi-center study at centers of excellence including Texas Cardiac Arrhythmia Institute at St. David’s Medical Center  was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(T.M.) signals over conventional sources.

Forward-looking
Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future 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 and consequently, actual 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) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. 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.

Andrew Ballou

BioSig Technologies, Inc.

Vice President, Investor Relations

55 Greens Farms Road

Westport, CT 06880

[email protected]

203-409-5444, x133

Source: BioSig Technologies, Inc.

Released
August 24, 2022

Ayala Pharmaceuticals Selected to Present Efficacy and Tolerability Data on AL102 in Desmoid Tumors at the European Society for Medical Oncology (ESMO) 2022 Congress

Research, News, and Market Data on Ayala Pharmaceuticals

Oral presentation will feature results from Part A of the Phase
2/3 RINGSIDE clinical study

REHOVOT, Israel and WILMINGTON, Del., Aug. 24, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced that data on the efficacy and tolerability of investigational new drug AL102 from Part A of the Phase 2/3 RINGSIDE study will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress, to take place September 8-13, 2022 in Paris, France.

About the RINGSIDE study
The RINGSIDE pivotal Phase 2/3 study is a randomized multi-center trial. Part A of the study is evaluating the efficacy, safety, tolerability, and tumor volume by MRI after 16 weeks of AL102 in adult patients with desmoid tumors. It enrolled 42 patients and is evaluating 3 doses of AL102. Patients who participated in Part A will be eligible to enroll into an open-label extension study at the selected Part B dose, and long-term efficacy and safety will be monitored. Part B of the study will be double-blind, placebo-controlled, and will start immediately after dose selection from part A, enrolling up to 156 adult and adolescent patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures.

For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).

About Desmoid Tumors
Desmoid tumors also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com. 

Contacts

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602

[email protected] 

Ayala Pharmaceuticals:
+1-857-444-0553

[email protected] 

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, the timing and results of any clinical trials or readouts, the sufficiency of cash to fund operations, and the anticipated impact of COVID-19, on our business. These forward-looking statements are based on management’s current expectations. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability; we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of AL101 and AL102; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability; we are heavily dependent on the success of AL101 and AL102, our most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, our business may be harmed; due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business; the outbreak of COVID-19, may adversely affect our business, including our clinical trials; our ability to use our net operating loss carry forwards to offset future taxable income may be subject to certain limitations; our product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop product candidates is novel and may never lead to marketable products; we were not involved in the early development of our lead product candidates; therefore, we are dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for our product candidates; enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control; if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed; our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; the market opportunities for AL101 and AL102, if approved, may be smaller than we anticipate; we may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; we have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates; even if we obtain FDA approval for our product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential; we have been granted Orphan Drug Designation for AL101 for the treatment of ACC and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates; although we have received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; we face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively; we are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates; our existing collaboration with Novartis is, and any future collaborations will be, important to our business. If we are unable to maintain our existing collaboration or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected; enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set; if we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our markets; we may engage in acquisitions or in-licensing transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Tuesday, August 23, 2022

Baudax Bio (BXRX)
Notice of Patent Allowance For Claims Covering ANJESO

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Notice of Allowance for patent application.  Yesterday, Baudax Bio announced the US Patent and Trademark Office (USPTO) provided a Notice of Allowance for patent application No. 16/297095 (the ‘095 application).  The USPTO typically issues a Notice after determining the patent application should be granted.

The Patent should be granted in the next few months.  The patent application covers the multiple doses of ANJESO for the treatment of moderate to severe pain, and a reduction in use of rescue analgesics 48 hours following the first dose.  The patent from the ‘095 titled application “Methods of administering intravenous meloxicam in a bolus dose”, once issued, will be eligible for listing in the FDA’s Orange Book. …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Image Credit: NIH

Tissue Model Reveals Key Players in Liver Regeneration

Anne Trafton | MIT News
Office

The human liver has amazing regeneration capabilities: Even if up to 70 percent of it is removed, the remaining tissue can regrow a full-sized liver within months.

Taking advantage of this regenerative capability could give doctors many more options for treating chronic liver disease. MIT engineers have now taken a step toward that goal, by creating a new liver tissue model that allows them to trace the steps involved in liver regeneration more precisely than has been possible before.

The new model can yield information that couldn’t be gleaned from studies of mice or other animals, whose biology is not identical to that of humans, says Sangeeta Bhatia, the leader of the research team.

“For years, people have been identifying different genes that seem to be involved in mouse liver regeneration, and some of them seem to be important in humans, but they have never managed to figure out all of the cues to make human liver cells proliferate,” says Bhatia, the John and Dorothy Wilson Professor of Health Sciences and Technology and of Electrical Engineering and Computer Science at MIT and a member of MIT’s Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science.

The new study, which appears this week in the Proceedings of the National Academy of Sciences, has identified one molecule that appears to play a key role, and also yielded several other candidates that the researchers plan to explore further.

The lead author of the paper is Arnav Chhabra, a former MIT graduate student and postdoc.

Regeneration on a Chip

Most of the patients who need liver transplants suffer from chronic illnesses such as viral hepatitis, fatty liver disease, or cancer. However, if researchers had a reliable way to stimulate the liver to regenerate on its own, some transplants could be avoided, Bhatia says. Or, such stimulation might be used to help a donated liver grow after being transplanted.

From studies in mice, researchers have learned a great deal about some of the regeneration pathways that are activated after liver injury or illness. One key factor is the reciprocal relationship between hepatocytes (the main type of cell found in the liver) and endothelial cells, which line the blood vessels. Hepatocytes produce factors that help blood vessels develop, and endothelial cells generate growth factors that help hepatocytes proliferate.

Another contributor that researchers have identified is fluid flow in the blood vessels. In mice, an increase in blood flow can stimulate the endothelial cells to produce signals that promote regeneration.

To model all of these interactions, Bhatia’s lab teamed up with Christopher Chen, the William F. Warren Distinguished Professor of Biomedical Engineering at Boston University, who designs microfluidic devices with channels that mimic blood vessels. To create these models of “regeneration on a chip,” the researchers grew blood vessels along one of these microfluidic channels and then added multicellular spheroid aggregates derived from liver cells from human organ donors.

The chip is designed so that molecules such as growth factors can flow between the blood vessels and the liver spheroids. This setup also allows the researchers to easily knock out genes of interest in a specific cell type and then see how it affects the overall system.

Using this system, the researchers showed that increased fluid flow on its own did not stimulate hepatocytes to enter the cell division cycle. However, if they also delivered an inflammatory signal (the cytokine IL-1-beta), hepatocytes did enter the cell cycle.

When that happened, the researchers were able to measure what other factors were being produced. Some were expected based on earlier mouse studies, but others had not been seen before in human cells, including a molecule called prostaglandin E2 (PGE2).

The MIT team found high levels of this molecule, which is also involved in zebrafish regeneration, in their liver regeneration system. By knocking out the gene for PGE2 biosynthesis in endothelial cells, the researchers were able to show that those cells are the source of PGE2, and they also demonstrated that this molecule stimulates human liver cells to enter the cell cycle.

Human-Specific Pathways

The researchers now plan to further explore some of the other growth factors and molecules that are produced on their chip during liver regeneration.

“We can look at the proteins that are being produced and ask, what else on this list has the same pattern as the other molecules that stimulate cell division, but is novel?” Bhatia says. “We think we can use this to discover new human-specific pathways.”

In this study, the researchers focused on molecules that stimulate cells to enter cell division, but they now hope to follow the process further along and identify molecules needed to complete the cell cycle. They also hope to discover the signals that tell the liver when to stop regenerating.

Bhatia hopes that eventually researchers will be able to harness these molecules to help treat patients with liver failure. Another possibility is that doctors could use such factors as biomarkers to determine how likely it is that a patient’s liver will regrow on its own.

“Right now when patients come in with liver failure, you have to transplant them because you don’t know if they’re going to recover on their own. But if we knew who had a robust regenerative response, and if we just needed to stabilize them for a little while, we could spare those patients from transplant,” Bhatia says.

The research was funded in part by the National Institutes of Health, the National Science Foundation Graduate Research Fellowship Program, Wellcome Leap, and the Paul and Daisy Soros Fellowship Program.

Reprinted with the permission  MIT News http://news.mit.edu/

Virtual Roadshow – August 23 Lineage Cell Therapeutics – Brian M. Culley, CEO Join Lineage Cell Therapeutics CEO Brian M. Culley for this exclusive corporate presentation, followed by a Q & A session moderated by Robert LeBoyer, Noble’s senior research analyst, featuring questions taken from the audience. Registration is free and open to all investors, at any level Register Now

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Baudax Bio receives notice of allowance for U.S. Patent Application covering use of ANJESO® for the treatment of moderate to severe pain

Research, News, and Market Data on Baudax Bio

August 22, 2022 8:00am EDT

MALVERN, Pa., Aug. 22, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, announced today that the United States Patent and Trademark Office (“USPTO”) has provided a Notice of Allowance for patent application No. 16/297,095, titled “Methods of administering intravenous meloxicam in a bolus dose”, which includes claims covering the use of multiple doses of ANJESO^® for the treatment of moderate to severe pain resulting in a reduction in summed pain intensity difference and also a reduction in the use of rescue analgesia 48 hours following the first dose. (the “’095 Application”). A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application. A patent from the recently allowed application is expected to be issued in the coming months. Once issued, the ‘095 Application will be eligible for listing in the United States Food and Drug
Administration’s (FDA) Orange Book: Approved Drug Products with Therapeutic
Equivalence Evaluations as it relates to ANJESO^®.

Once issued, the ‘095 Application will be the second ANJESO^® patent to be listed in the Orange Book with an expiry date of March 2039. Upon issuance, the ‘095 application will join seven other patents listed in the Orange Book, amongst others owned or licensed by Baudax that currently provide exclusivity to the ANJESO
^® franchise. The ‘095 Application emphasizes ANJESO’s
^® potential to treat moderate to severe pain while potentially reducing the use of rescue analgesics.

“We are pleased by the progress we have made in the United States Patent and Trademark Office and the continued recognition of the inventive nature of our ANJESO^® franchise,” said Gerri Henwood, Baudax Bio’s President and Chief Executive Officer. “The ‘095 Application is expected to provide a significant barrier for generic entry and are expected to be joined by other patents currently pending in the USPTO.”

About ANJESO^®

ANJESO^® (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO^® is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. As a non-opioid, Baudax Bio believes ANJESO^® has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO
^® was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO^®, the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO^®, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Forward-Looking
Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including statements relating to Baudax Bio’s patent portfolio, and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

CONTACT:

Investor Relations
Contact:

Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
[email protected]

Media Contact:

Argot Partners
David Rosen
(212) 600-1902
[email protected]

Source: Baudax Bio, Inc.

Released August 22, 2022

Tonix Pharmaceuticals Initiates Enrollment in Phase 2 PREVAIL Study of TNX-102 SL for the Treatment of Long COVID

Research, News, and Market Data on Tonix Pharmaceuticals

August 22, 2022 7:00am EDT

Results from Planned Interim Analysis Expected
First Half 2023

Long COVID Afflicts More Than 30% of Patients
Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is
Expected to be a Global Health Burden

Concerning Rate of Opioid Use Observed in Long
COVID Patients with Multi-Site Pain

CHATHAM, N.J., Aug. 22, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 2 PREVAIL study of TNX-102 SL¹ as a potential treatment for a subset of patients with Long COVID syndrome (Long COVID) whose symptoms overlap with fibromyalgia. Long COVID is known officially as Post-Acute Sequelae of COVID-19 (PASC)².

“We are pleased to be starting a Phase 2 clinical study in this indication which is a growing problem and for which no drug is currently approved. We believe Long COVID, characterized by multi-site pain, fatigue and sleep disturbance, has features of central sensitization syndromes similar to fibromyalgia. Fibromyalgia is considered one of the clusters of chronic overlapping pain conditions that have much in common with Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Findings from our retrospective observational database study in over 50,000 Long COVID patients showed that more than 40% of Long COVID patients in the sample have fibromyalgia-like multi-site pain symptoms, suggesting that we should be able to recruit a robust cohort of participants to test the effects of TNX-102 SL in treating this condition. Our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia. We recognize the need to better understand and develop treatment for Long COVID.”

“This retrospective observational database study also revealed the rate of opioid use in Long COVID patients,” said Greg Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Opioid use was noted in 36% of Long COVID patients with multi-site pain symptoms relative to 19% of Long COVID patients without multi-site pain. In those with multi-site pain, opioid use increased to 39% of patients when fatigue was present, and 50% when insomnia was present. We look forward to continuing to progress this study with the goal of developing a non-addictive, centrally acting analgesic which potentially treats not only pain but also the sleep disturbance and fatigue that are common in Long COVID.”

About the Phase 2 PREVAIL
Study

The Phase 2 PREVAIL study is 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with post-acute sequelae of SARS-COV-2 infection (PASC). The trial is being conducted at approximately 30 sites in the U.S. and is expected to enroll approximately 470 patients (235 per arm) who will be randomized in a 1:1 ratio to treatment with TNX-102 SL or placebo tablets. The primary efficacy endpoint will be changed from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Key secondary efficacy endpoints include change from baseline in self-reported scores for sleep disturbance, fatigue and cognitive function. An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of possible sample size re-estimation or to stop the study early for efficacy, currently anticipated in the first half of 2023.

For more information, see ClinicalTrials.gov Identifier: NCT05472090.

About Long COVID or
Post-Acute Sequelae of COVID-19 (PASC)

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for many months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.^3-5 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.^4-7 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2020.⁸ While the vaccines available in the U.S. through either FDA approval or under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.

¹TNX-102 SL is an
investigational new drug and has not been approved for any indication.

²Feb. 24, 2021 – White
House COVID-19 Response Team press briefing; Feb 25, 2021 – policy brief from
the World Health Organization on long COVID.

³Harris, H, et
al. Tonix data on file. 2022

⁴Briggs, A, and Vassall,
A. (2021) “Count the cost of disability caused by COVID-19.” Nature
593(7860): 502-505.

⁵Nittas V, et al. (2022)
“Long COVID Through a Public Health Lens: An Umbrella Review.” Public
Health Rev. 43:1604501. Published 2022 Mar 15. doi:10.3389/phrs.2022.1604501

⁶Davis, HE., et al. (2021)
“Characterizing long COVID in an international cohort: 7 months of
symptoms and their impact.” EClinicalMedicine 38: 101019.

⁷Martin C, et al. (2021)
“A model framework for projecting the prevalence and impact of Long-COVID in
the UK.” PLoS One. 16(12):e0260843. Published 2021 Dec
2. doi:10.1371/journal.pone.0260843

⁸The NIH provision of
Title III Health and Human Services, Division M–Coronavirus Response and
Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated
Appropriations Act of 2021. The bill was enacted into law on 27 December 2020,
becoming Public Law 116-260.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin-5-HT2A, ?1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for Long COVID, fibromyalgia, PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

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 first 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 first half 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 fourth quarter of 2022. 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 first half 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. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.

^*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
August 22, 2022

Image Credit: The Focal Project (Flickr)

Sixteen Years After the Human Genome Project Completion, Regenerative Medicine May Hit its Stride

Bluebird Bio’s performance this past week shows what the power of FDA approval can do when a biotech company gets the green light. Not only did investors enjoy a 51.7% increase in the gene therapy company’s stock price, but patients can now overcome a severe genetic disease. Gene therapies and regenerative medicine are now beginning to blossom, 16 years after the last human chromosome was mapped, completing the human genome project. Quite a few specialized biotech companies have been started within the past 16 years, and many have a product pipeline in various stages of FDA approval. Below is information on Bluebird and two other public companies involved in genetic medicine that you may want to pay attention to.

Source: Koyfin

Bluebird Bio (BLUE)

Bluebird Bio’s blood disorder gene therapy was approved a few days earlier than anticipated. The approval of Zynteglo is exciting for those whose lives will be changed by the gene therapy, investors that have had confidence in the surrounding science, and of course, everyone working at Bluebird bio. Congratulations.

A downside to the FDA approval is that the therapy for betibeglogene autotemcel (beti-cel), will initially cost $2.8 million for those receiving it. More positively, the pediatric and adult patients that will benefit have been requiring ongoing red blood cell transfusions. Zynteglo is a one-time gene therapy, so those afflicted can receive transfusion independence.

Lineage Cell Therapeutics (LCTX)

Lineage Cell Therapeutics is a clinical-stage biotech company developing new cellular therapies for degenerative retinal diseases, neurological conditions associated with demyelination, and helping the body fight cancer. At the company’s core are two proprietary technology platforms: cell replacement and cell and drug delivery. Its cell replacement platform creates new cells and tissues with its pluripotent and progenitor cell technologies. The company’s cell and drug delivery programs are based upon its proprietary HyStem cell and drug delivery matrix technology.

There is no better way for any investor to develop an understanding of a biotech company in the regenerative medicine or gene therapy space than to have its products and pipeline explained to them by the CEO. Channelchek and Noble Capital Markets have arranged for an online interactive roadshow (bring your questions) for interested investors to attend. This will be held on Tuesday (August 23). More information is available here.

Miromatrix (MIRO)

Miromatrix is a company that may one day eliminate waitlists for organ transplants. The company claims to lead the development of bioengineered organs for transplantation with over 118 issued patents worldwide. The technology is able to be applied across many of needs. Specifically, they are currently focused on creating transplantable kidneys (MiroKidney) and livers (MiroLiver) with expectations to also bioengineer other critical organs like lungs, pancreas, and heart.

The decellularization technology is supported through pre-clinical and animal studies that the FDA cleared in previously commercialized matrix products. The company’s bioengineered organs have the potential to eliminate ongoing therapies and prolong life. They also are expected to reduce costs across many areas of the healthcare system. 

Take Away

The FDA approval of Zynteglo for Bluebird Bio and the stock performance was a reminder this week of the potential for companies in the regenerative medicine space to make a difference. It has been 16 years since the human genome project was completed. Many of these companies were started shortly after; perhaps their research and development are about to pay off.

Explore more companies like BLUE, LCTX, and MIRO by registering for Channelchek and exploring under the “COMPANY Data” tab.

Paul Hoffman

Managing Editor, Channelchek

Virtual Roadshow – August 23 Lineage Cell Therapeutics – Brian M. Culley, CEO Join Lineage Cell Therapeutics CEO Brian M. Culley for this exclusive corporate presentation, followed by a Q & A session moderated by Robert LeBoyer, Noble’s senior research analyst, featuring questions taken from the audience. Registration is free and open to all investors, at any level Register Now

Suggested Content

Stem Cell-Derived Retinal Pigment Epithelium Cells – Vision for the Future

Preventing the Immune System from Rejecting Gene Therapy

Pros and Cons of FDA Funded in Part by Companies

Cells that Can be Produced from Stem Cells

Source

https://en.wikipedia.org/wiki/Human_Genome_Project#History

https://www.zynteglo.com/

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Avivagen Announces New Dairy Customer in Mexico

Research, News, and Market Data on Avivagen

• Family-owned dairy business with established reputation for high-quality products turning to OxC-beta^TM to support quality of milk
• Order procured through Meyenberg International, Avivagen’s Mexican distribution partner

Ottawa, ON /Business Wire/ August 19, 2022 /– Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce it has secured a promising new customer in the Mexican dairy industry.  The agreement will see the customer order 220 kg/month of OxC-beta^TM over a three-month period, beginning in September 2022.

“This new agreement represents the continued expansion of OxC-beta™ use within the dairy industry, a key growth market for Avivagen due to its size and positive economics,” said Kym Anthony, Chief Executive Officer, Avivagen Inc. “Mexico remains an important geographic region for us. We are excited about the potential for this first dairy order in the country to lead to others in this vital industry.”

The new customer, based in the Jalisco State region of Mexico, is a thirty-year old, family-owned business with a history of supplying high quality dairy products. The order follows a thorough assessment by the customer of numerous trials previously conducted in Mexico with OxC-beta™, resulting in higher quality milk and yields across a range of important metrics.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance.  It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, Vietnam and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements
This
news release includes certain forward-looking statements that are based upon
the current expectations of management. Forward-looking statements involve
risks and uncertainties associated with the business of Avivagen Inc. and the
environment in which the business operates. Any statements contained herein
that are not statements of historical facts may be deemed to be
forward-looking, including those identified by the expressions “aim”,
“anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”,
“if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”,
“potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and
similar expressions.

Statements set out in this news release relating to the future
growth and prospects for Avivagen, the potential for additional orders for
Avivagen’s products, future shipments and the possibility for OxC-beta™
Livestock to replace antibiotics in livestock feeds as growth promoters are
forward-looking statements. These forward-looking statements are subject to a
number of risks and uncertainties that could cause actual results or events to
differ materially from current expectations. For instance, Avivagen’s products
may not gain market acceptance or regulatory approval in new jurisdictions or
for new applications and may not be widely accepted as a replacement for
antibiotics as growth promoters in livestock feeds due to many factors, many of
which are outside of Avivagen’s control.  Orders may be cancelled for many
reasons outside of Avivagen’s control.   Readers are referred to the
risk factors associated with the business of Avivagen set out in Avivagen’s most
recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen
assumes no obligation to update the forward-looking statements, or to update
the reasons why actual results could differ from those reflected in the
forward-looking statements.

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

For more information:

Avivagen Inc.

Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: 
[email protected]

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164

Website: 
www.avivagen.com
Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.