Thursday, June 30, 2022

BioSig Technologies (BSGM)
BioSig Closes Common Share Offering

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(TM) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

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.

Offering priced. Last Friday, June 24, 2022, BioSig Technologies priced a public offering of common shares on a “best efforts” basis.  The offering was for up to 4.666667 million shares at a price of $0.75 per share. The offering closed on June 29, 2022 with 4.341667 million shares sold, and proceeds to the company of around $2.9 million. 

A bit unexpected, timing-wise, but supports PURE EP commercialization.  BioSig had filed an ATM agreement for up to $10 million May 17, 2022 but chose an alternative “best efforts” offering instead.  While we expected funding needs in the third quarter, we are bit surprised the Company raised funds now. That said, BioSig is ramping up commercial activities as they shift to a national strategy….

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. 

Tonix Pharmaceuticals Announces Trial Design of New Phase 2 Clinical Study of TNX-1300 for Cocaine Intoxication

New Trial Design is Single-Blind, Placebo-Controlled, Potential Pivotal Study, Pending FDA Agreement

Expected to Include Women Based on Reproductive Toxicology Studies, Pending FDA Agreement

Planning to Include Patients Who Have Received Naloxone to Increase Enrollment

CHATHAM, N.J., June 27, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the design of a new Phase 2 clinical trial of TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) for the treatment of cocaine intoxication. This new protocol has the potential to serve as a pivotal trial. TNX-1300 is a recombinant enzyme that efficiently degrades and metabolizes cocaine in cocaine users, as demonstrated in a prior Phase 2a randomized, double-blind, placebo-controlled clinical study, providing support of the use of TNX-1300 as a treatment for cocaine intoxication.¹ The Company plans to submit the new protocol to the U.S. Food and Drug Administration (FDA).

A positive Phase 2a study of volunteer cocaine users in a controlled laboratory setting has been previously completed. TNX-1300 has been granted Breakthrough Therapy designation by the FDA. As a biologic and new molecular entity, TNX-1300 is eligible for 12 years of U.S. market exclusivity upon approval by the FDA, in addition to expected patent protection through 2029.

“The design of the new Phase 2 trial has the potential to serve as a pivotal trial,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are approximately 505,000 emergency room visits annually involving cocaine use, with approximately 61,000 of the visits involving detox services to treat cocaine overdose. In 2020, about 19,447 overdose deaths involving cocaine occurred in the U.S.² We believe that TNX-1300 has the potential to be a new treatment option for the substantial morbidity and mortality caused by cocaine intoxication.”

“The new study replaces the Phase 2 open-label trial with TNX-1300 for cocaine intoxication originally expected to start in the second quarter of 2022, which was designed to evaluate feasibility of enrollment,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “We expect to be able to include women in this study, pending FDA agreement, since we have now completed the required reproductive toxicology studies in which no incidents of toxicity were observed. Additionally, we will now admit patients into the study who might have received naloxone due to the intoxication symptoms they are presenting. Based on our learnings from the feasibility study, excluding patients who had received naloxone at the time of intoxication was a hindrance to enrollment. Both of these changes in the new protocol should improve our ability to enroll appropriate patients in a more timely manner.”

Currently there is no specific pharmacotherapy indicated for cocaine intoxication, a state characterized by acute agitation, hyperthermia, tachycardia, arrhythmias and hypertension, with the potential life-threatening sequalae of myocardial infarction, cerebrovascular accident, rhabdomyolysis, respiratory failure and seizures. Patients are currently managed only by supportive care for the adverse effects of cocaine overdose on the cardiovascular and central nervous systems. By targeting the cause rather than the symptoms of cocaine intoxication, the Company believes TNX-1300 may offer significant advantages to the current standard of care for cocaine overdose.

The Phase 2 trial is a single-blind, open-label, placebo-controlled, randomized study comparing the safety of a single 200 mg dose of TNX-1300 to standard of care alone for the treatment of signs and symptoms of acute cocaine intoxication in approximately 60 emergency department patients presenting with cocaine intoxication. During the treatment period, subjects assigned to receive TNX-1300 will receive a single IV injection of TNX-1300 administered over 2 minutes or less; whereas subjects assigned to receive standard of care alone will receive a single IV saline injection over 2 minutes or less. Both groups will be observed according to the site’s emergency department protocol. For both study arms, signs and symptoms of cocaine intoxication will be assessed at pre-determined time points after treatment (30 minutes and then at 60, 90, 120, 180, and 240 minutes). After randomization, blood samples will be drawn at specific time points. The primary endpoint of the study is reduction of systolic blood pressure associated with acute cocaine intoxication identified at study baseline comparing TNX-1300 and standard of care after 60 minutes. A variety of secondary endpoints will be measured, including reduction of circulating cocaine, cocaethylene and ecgonine methyl ester levels after at multiple post-baseline timepoints. Safety assessments will consist of incidence and severity of treatment-emergent adverse events, adverse events of special interest, 12-lead ECGs, and vital signs.

About TNX-1300

TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is being developed under an Investigational New Drug application (IND) for the treatment of cocaine intoxication.  TNX-1300 is a recombinant protein enzyme produced through rDNA technology in a non-disease-producing strain of E. coli bacteria.  Cocaine esterase (CocE) was identified in bacteria (Rhodococcus) that uses cocaine as its sole source of carbon and nitrogen and that grows in soil surrounding coca plants.³ The gene encoding CocE was identified and the protein was extensively characterized.^3-6 CocE catalyzes the breakdown of cocaine into metabolite ecgonine methyl ester and benzoic acid.  Wild-type CocE is unstable at body temperature, so targeted mutations were introduced in the CocE gene and resulted in the T172R/G173Q double-mutant CocE, which is active for approximately 6 hours at body temperature⁷. In a Phase 2 study, TNX-1300, at 100 mg or 200 mg i.v. doses, was well tolerated and rapidly reduced cocaine effects after cocaine 50 mg i.v. challenge.¹

About Cocaine Intoxication and Overdose

Cocaine is an illegal recreational drug which is taken for its pleasurable effects and associated euphoria. Pharmacologically, cocaine blocks the reuptake of the neurotransmitter dopamine from central nervous system synapses, resulting in the accumulation of dopamine within the synapse and an amplification of dopamine signaling and its role in creating positive feeling. With the continued use of cocaine, however, intense cocaine cravings occur resulting in a high potential for abuse and addiction (dependence), as well as the risk of cocaine intoxication. Cocaine intoxication refers to the deleterious effects on several body systems, especially those involving the cardiovascular system. Common symptoms of cocaine intoxication include tachyarrhythmias and elevated blood pressure, either of which can be life-threatening. As a result, individuals with known or suspected cocaine intoxication are sent immediately to the emergency department, preferably by ambulance in case cardiac arrest occurs during transit. There are approximately 505,000 emergency room visits for cocaine abuse each year in the U.S., of which 61,000 require detoxification services. According to the National Institute on Drug Abuse, in 2020 the number of overdose death involving cocaine reached 19,447 individuals.² According to a recent report by the U.S. Centers for Disease Control and Prevention,⁷ among all 2019 U.S. drug overdose deaths, approximately nearly 1 in 5 involved cocaine. In 2019, Black Americans experienced the highest death rate for overdoses involving cocaine, at 10.7 per 100,000.⁸

References

¹ Nasser AF, Fudala PJ, Zheng B, Liu Y, Heidbreder C. A randomized, double-blind, placebo-controlled trial of RBP-8000 in cocaine abusers: pharmacokinetic profile of rbp-8000 and cocaine and effects of RBP-8000 on cocaine-induced physiological effects. J Addict Dis. 2014;33(4):289-302.

² National Institute on Drug Abuse (NIDA) National Institute on Drug Abuse – https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates; accessed June 19, 2022

³ Bresler MM, Rosser SJ, Basran A, Bruce NC. Gene cloning and nucleotide sequencing and properties of a cocaine esterase from Rhodococcus sp. strain MB1. Appl Environ Microbiol. 2000. 66(3):904-8.

⁴ Larsen NA, Turner JM, Stevens J, Rosser SJ, Basran A, Lerner RA, Bruce NC, Wilson IA. Crystal structure of a bacterial cocaine esterase. Nat Struct Biol. 2002. 9(1):17-21.

⁵ Turner JM, Larsen NA, Basran A, Barbas CF 3rd, Bruce NC, Wilson IA, Lerner RA. Biochemical characterization and structural analysis of a highly proficient cocaine esterase. Biochemistry. 2002. 41(41):12297-307.

⁶ Gao D, Narasimhan DL, Macdonald J, Brim R, Ko MC, Landry DW, Woods JH, Sunahara RK, Zhan CG. Thermostable variants of cocaine esterase for long-time protection against cocaine toxicity. Mol Pharmacol. 2009. 75(2):318-23.

⁷ https://www.cdc.gov/drugoverdose/deaths/other-drugs.html; accessed June 19, 2022

⁸ Kariisa M, Seth P, Scholl L, Wilson N, Davis NL. Drug overdose deaths involving cocaine and psychostimulants with abuse potential among racial and ethnic groups – United States, 2004-2019. Drug Alcohol Depend. 2021 Oct 1;227:109001. doi: 10.1016/j.drugalcdep.2021.109001. Epub 2021 Aug 28. PMID: 34492555.

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 expects to initiate a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is Phase 2 ready and has been granted Breakthrough Therapy Designation by the FDA. 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 second half of 2022. 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 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 second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

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

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

Forward Looking Statements

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

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
Westwicke/ICR
peter.vozzo@westwicke.com
(443) 213-0505

BioSig Announces Pricing of Public Offering of Common Stock

News and Market Data on BioSig Technologies

Westport, CT, June 24, 2022 (GLOBE NEWSWIRE) — 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 pricing of its previously-announced best efforts underwritten public offering of up to 4,666,667 shares of its common stock, $0.001 par value per share, at a price to the public of $0.75 per share. The gross proceeds to BioSig from this offering are expected to be $3,500,000.25, before deducting the underwriting discount and other estimated offering expenses payable by BioSig. The offering is expected to close on June 28, 2022, subject to customary closing conditions.  

Laidlaw & Company (UK) Ltd. is acting as sole book-running manager for the offering.

BioSig intends to use the net proceeds from the offering for the continuation of commercialization activities related to the PURE EP™ System, including additional support for organizational development, to fund working capital, and for general corporate purposes and other capital expenditures.

A shelf registration statement on Form S-3 (Registration No. 333-251859) relating to the public offering of the shares of common stock described above was previously filed with the Securities and Exchange Commission (SEC) and declared effective on January 12, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the underwritten public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from Laidlaw & Company (UK) Ltd., 521 Fifth Ave., 12th Floor, New York, NY 10175, Attention: Syndicate Dept.; email: syndicate@laidlawltd.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

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(TM) 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(TM) was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights.

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, the satisfaction of customary closing conditions relating to the public offering 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.

Source: BioSig Technologies, Inc.

Released June 24, 2022

Image Credit: D. Burnette and J. Lippencott-Schwarz (NIH)

New Model Helps Identify Mutations that Drive Cancer

Anne Trafton | MIT
News Office

Cancer cells can have thousands of mutations in their DNA. However, only a handful of those actually drive the progression of cancer; the rest are just along for the ride.

Distinguishing these harmful driver mutations from the neutral passengers could help researchers identify better drug targets. To boost those efforts, an MIT-led team has built a new computer model that can rapidly scan the entire genome of cancer cells and identify mutations that occur more frequently than expected, suggesting that they are driving tumor growth. This type of prediction has been challenging because some genomic regions have an extremely high frequency of passenger mutations, drowning out the signal of actual drivers.

“We created a probabilistic, deep-learning method that allowed us to get a really accurate model of the number of passenger mutations that should exist anywhere in the genome,” says Maxwell Sherman, an MIT graduate student. “Then we can look all across the genome for regions where you have an unexpected accumulation of mutations, which suggests that those are driver mutations.”

In their new study, the researchers found additional mutations across the genome that appear to contribute to tumor growth in 5 to 10 percent of cancer patients. The findings could help doctors to identify drugs that would have greater chance of successfully treating those patients, the researchers say. Currently, at least 30 percent of cancer patients have no detectable driver mutation that can be used to guide treatment.

Sherman, MIT graduate student Adam Yaari, and former MIT research assistant Oliver Priebe are the lead authors of the study, which appears today in Nature Biotechnology. Bonnie Berger, the Simons Professor of Mathematics at MIT and head of the Computation and Biology group at the Computer Science and Artificial Intelligence Laboratory (CSAIL), is a senior author of the study, along with Po-Ru Loh, an assistant professor at Harvard Medical School and associate member of the Broad Institute of MIT and Harvard. Felix Dietlein, an associate professor at Harvard Medical School and Boston Children’s Hospital, is also an author of the paper.

A New Tool

Since the human genome was sequenced two decades ago, researchers have been scouring the genome to try to find mutations that contribute to cancer by causing cells to grow uncontrollably or evade the immune system. This has successfully yielded targets such as epidermal growth factor receptor (EGFR), which is commonly mutated in lung tumors, and BRAF, a common driver of melanoma. Both of these mutations can now be targeted by specific drugs.

While those targets have proven useful, protein-coding genes make up only about 2 percent of the genome. The other 98 percent also contains mutations that can occur in cancer cells, but it has been much more difficult to figure out if any of those mutations contribute to cancer development.

“There has really been a lack of computational tools that allow us to search for these driver mutations outside of protein-coding regions,” Berger says. “That’s what we were trying to do here: design a computational method to let us look at not only the 2 percent of the genome that codes for proteins, but 100 percent of it.”

To do that, the researchers trained a type of computational model known as a deep neural network to          that occur more frequently than expected. As a first step, they trained the model on genomic data from 37 different types of cancer, which allowed the model to determine the background mutation rates for each of those types.

“The really nice thing about our model is that you train it once for a given cancer type, and it learns the mutation rate everywhere across the genome simultaneously for that particular type of cancer,” Sherman says. “Then you can query the mutations that you see in a patient cohort against the number of mutations you should expect to see.”

The data used to train the models came from the Roadmap Epigenomics Project and an international collection of data called the Pan-Cancer Analysis of Whole Genomes (PCAWG). The model’s analysis of this data gave the researchers a map of the expected passenger mutation rate across the genome, such that the expected rate in any set of regions (down to the single base pair) can be compared to the observed mutation count anywhere across the genome.

Changing the Landscape

Using this model, the MIT team was able to add to the known landscape of mutations that can drive cancer. Currently, when cancer patients’ tumors are screened for cancer-causing mutations, a known driver will turn up about two-thirds of the time. The new results of the MIT study offer possible driver mutations for an additional 5 to 10 percent of the pool of patients.

One type of noncoding mutation the researchers focused on is called “cryptic splice mutations.” Most genes consist of sequences of exons, which encode protein-building instructions, and introns, which are spacer elements that usually get trimmed out of messenger RNA before it is translated into protein. Cryptic splice mutations are found in introns, where they can confuse the cellular machinery that splices them out. This results in introns being included when they shouldn’t be.

Using their model, the researchers found that many cryptic splice mutations appear to disrupt tumor suppressor genes. When these mutations are present, the tumor suppressors are spliced incorrectly and stop working, and the cell loses one of its defenses against cancer. The number of cryptic splice sites that the researchers found in this study accounts for about 5 percent of the driver mutations found in tumor suppressor genes.

Targeting these mutations could offer a new way to potentially treat those patients, the researchers say. One possible approach that is still in development uses short strands of RNA called antisense oligonucleotides (ASOs) to patch over a mutated piece of DNA with the correct sequence.

“If you could make the mutation disappear in a way, then you solve the problem. Those tumor suppressor genes could keep operating and perhaps combat the cancer,” Yaari says. “The ASO technology is actively being developed, and this could be a very good application for it.”

Another region where the researchers found a high concentration of noncoding driver mutations is in the untranslated regions of some tumor suppressor genes. The tumor suppressor gene TP53, which is defective in many types of cancer, was already known to accumulate many deletions in these sequences, known as 5’ untranslated regions. The MIT team found the same pattern in a tumor suppressor called ELF3.

The researchers also used their model to investigate whether common mutations that were already known might also be driving different types of cancers. As one example, the researchers found that BRAF, previously linked to melanoma, also contributes to cancer progression in smaller percentages of other types of cancers, including pancreatic, liver, and gastroesophageal.

“That says that there’s actually a lot of overlap between the landscape of common drivers and the landscape of rare drivers. That provides opportunity for therapeutic repurposing,” Sherman says. “These results could help guide the clinical trials that we should be setting up to expand these drugs from just being approved in one cancer, to being approved in many cancers and being able to help more patients.”

The research was funded, in part, by the National Institutes of Health and the National Cancer Institute.

Reprinted with permission of MIT News (http://news.mit.edu/)

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BioSig Announces Proposed Public Offering of Common Stock

News and Market Data on BioSig Technologies

Westport, CT, June 23, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it intends to offer shares of its common stock in a “best efforts” underwritten public offering. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Laidlaw & Company (UK) Ltd. is acting as sole book-running manager for the offering.

BioSig intends to use the net proceeds from the offering for the continuation of commercialization activities related to the PURE EP™ System, including additional support for organizational development, to fund working capital, and for general corporate purposes and other capital expenditures.

A shelf registration statement on Form S-3 (Registration No. 333-251859) relating to the public offering of the shares of common stock described above was previously filed with the Securities and Exchange Commission (SEC) and declared effective on January 12, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement (when available) and accompanying prospectus relating to the offering may be obtained from Laidlaw & Company (UK) Ltd., 521 Fifth Ave., 12th Floor, New York, NY 10175, Attention: Syndicate Dept.; email: syndicate@laidlawltd.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

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 computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

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) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) 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.

Source: BioSig Technologies, Inc.

Released June 23, 2022

Image Credit: Pixabay (Pexels)

How Do Drugs Know Where To Go In The Body? Why Some Medications Are Swallowed While Others Are Injected

When you take aspirin for a headache, how does the aspirin know to travel to your head and alleviate the pain?

The short answer is, it doesn’t: Molecules can’t transport themselves through the body, and they don’t have control over where they eventually end up. But researchers can chemically modify drug molecules to make sure that they bind strongly to the places we want them and weakly to the places we don’t.

Pharmaceutical products contain more than just the active drug that directly affects the body. Medications also include “inactive ingredients,” or molecules that enhance the stability, absorption, flavor and other qualities that are critical to allowing the drug to do its job. For example, the aspirin you swallow also has ingredients that both prevent the tablet from fracturing during shipping and help it break apart in your body.

As a pharmaceutical scientist, I’ve been studying drug delivery for the past 30 years. That is, developing methods and designing nondrug components that help get a medication where it needs to go in the body. To better understand the thought process behind how different drugs are designed, let’s follow a drug from when it first enters the body to where it eventually ends up.

How Drugs
are Absorbed in the Body

When you swallow a tablet, it will initially dissolve in your stomach and intestines before the drug molecules are absorbed into your bloodstream. Once in the blood, it can circulate throughout the body to access different organs and tissues.

Drug molecules affect the body by binding to different receptors on cells that can trigger a particular response. Even though drugs are designed to target specific receptors to produce a desired effect, it is impossible to keep them from continuing to circulate in the blood and binding to nontarget sites that potentially cause unwanted side effects.

Image Credit: Jorgen Schyberg (Flickr)

Drug molecules circulating in the blood also degrade over time and eventually leave the body in your urine. A classic example is the strong smell your urine might have after you eat asparagus because of how quickly your kidney clears asparagusic acid. Similarly, multivitamins typically contain riboflavin, or vitamin B2, which causes your urine to turn bright yellow when it is cleared. Because how efficiently drug molecules can cross the intestinal lining can vary depending on the drug’s chemical properties, some of the drugs you swallow never get absorbed and are removed in your feces.

Because not all of the drug is absorbed, this is why some medications, like those used to treat high blood pressure and allergies, are taken repeatedly to replace eliminated drug molecules and maintain a high enough level of drug in the blood to sustain its effects on the body.

Getting Drugs
to the Right Place

Compared with pills and tablets, a more efficient way of getting drug into the blood is to inject it directly into a vein. This way, all the drug gets circulated throughout the body and avoids degradation in the stomach.

Many drugs that are given intravenously are “biologics” or “biotechnology drugs,” which include substances derived from other organisms. The most common of these are a type of cancer drug called monoclonal antibodies, proteins that bind to and kill tumor cells. These drugs are injected directly into a vein because your stomach can’t tell the difference between digesting a therapeutic protein and digesting the proteins in a cheeseburger.

In other cases, drugs that need very high concentrations to be effective, such as antibiotics for severe infections, can be delivered only through infusion. While increasing drug concentration can help make sure enough molecules are binding to the correct sites to have a therapeutic effect, it also increases binding to nontarget sites and the risk of side effects.

One way to get a high drug concentration in the right location is to apply the drug right where it’s needed, like rubbing an ointment onto a skin rash or using eyedrops for allergies. While some drug molecules will eventually get absorbed into the bloodstream, they will be diluted enough that the amount of drug that reaches other sites is very low and unlikely to cause side effects. Similarly, an inhaler delivers the drug directly to the lungs and avoids affecting the rest of the body.

Patient Compliance

Finally, a key aspect in all drug design is to simply get patients to take medications in the right amounts at the right time.

Because remembering to take a drug several times a day is difficult for many people, researchers try to design drug formulations so they need to be taken only once a day or less.

Similarly, pills, inhalers or nasal sprays are more convenient than an infusion that requires traveling to a clinic for a trained clinician to inject it into your arm. The less troublesome and expensive it is to administer a drug, the more likely it is that patients will take their medication when they need it. However, sometimes infusions or injections are the only effective way that certain drugs can be administered.

Even with all the science that goes into understanding a disease well enough to develop an effective drug, it is often up to the patient to make it all work as designed.

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BioSig Announces New Evaluation Agreement for its PURE EP System with Cleveland Clinic

News and Market Data on BioSig Technologies

Leading Center of Excellence will participate in a 60-day
evaluation of The Company’s signal processing technology

Westport, CT, June 22, 2022 (GLOBE NEWSWIRE) — 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 it has entered an evaluation agreement for its PURE EP(TM) System with the Cleveland Clinic.

The evaluation agreement marks the first since BioSig inducted a new commercialization team. Consistent with The Company’s stated national rollout strategy, Cleveland Clinic will participate in a 60-day evaluation of BioSig’s PURE EP(TM) System. The Company recently announced that is has restructured its clinical support and installation teams to streamline and accelerate the pathway from product evaluation to adoption.

“We are excited to include Cleveland Clinic as an evaluation center for the Pure EP System. We look forward to working alongside their physicians to demonstrate the superior signal quality that can be achieved on even the most difficult arrhythmias,” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc. 

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 abnornmalities. To learn more, visit clevelandclinic.org. 

To date, over 75 physicians have completed over 2500 patient cases with the PURE EP(TM) System. The Company is in a national commercial launch of the PURE EP(TM) 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(TM) 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(TM) signals over conventional sources.

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(TM) 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(TM) was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights.

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) the geographic, social, and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) 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

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

Source: BioSig Technologies, Inc.

Released
June 22, 2022

Tonix Pharmaceuticals Announces Pricing of $30 Million Private Placement of Convertible Redeemable Preferred Stock

CHATHAM, N.J., June 22, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it has entered into a securities purchase agreement with certain institutional investors to purchase 2,500,000 shares of Series A convertible redeemable preferred stock and 500,000 shares of Series B convertible redeemable preferred stock. Each share of Series A and Series B preferred stock has a purchase price of $9.50, representing an original issue discount of 5% of the $10.00 stated value of each share. Each share of Series A and Series B preferred stock is convertible into shares of the Company’s common stock at an initial conversion price of $4.00 per share. Shares of the Series A and Series B preferred stock are convertible at the option of the holder at any time following the Company’s receipt of shareholder approval for an increase to the authorized shares of common stock of the Company from 50 million to 150 million. The Company will be permitted to redeem the Series A preferred stock at its option upon the fulfillment of certain conditions and subject to certain limitations. The Company and the holders of the Series A and Series B preferred stock also entered into a registration rights agreement to register the resale of the shares of common stock issuable upon conversion of the Series A and Series B preferred stock. Total gross proceeds from the offerings, before deducting discounts, placement agent’s fees and other estimated offering expenses, is $30 million.

The Series A and Series B preferred stock permits the holders thereof to vote together with the holders of the Company’s common stock on a proposal to effectuate an increase to the authorized shares of common stock of the Company at a special meeting of Company shareholders. The Series B preferred stock permits the holder to cast 2,500 votes per share of Series B preferred stock on such proposal, provided, that such votes must be cast in the same proportions as the shares of common stock and Series A preferred stock are voted on that proposal. Except as required by law or expressly provided by the certificate of designation, holders of the Series A and Series B preferred stock will not be permitted to vote on any other matters. The holders of the Series A and Series B preferred stock agreed not to transfer, offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of their shares of preferred stock until after the special meeting. The holders of the Series A and Series B preferred stock have the right to require the Company to redeem their shares of preferred stock for cash at 105% of the stated value of such shares commencing after the earlier of (i) the date on which the Company’s receives shareholder approval to increase the Company’s authorized shares of common stock or (ii) 60 days after the closing of the issuances of the Series A and Series B preferred stock and ending 90 days after such closing. The Company has the option to redeem the Series A preferred stock for cash at 105% of the stated value commencing after the Company’s shareholders’ approval of the increase to the authorized shares of common stock of the Company, subject to the holders’ rights to convert the shares prior to a redemption at the option of the Company.

The closing of the offering is expected to occur on or about June 24, 2022, subject to the satisfaction of customary closing conditions. Additional information regarding the securities described above and the terms of the offering are included in a Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission (“SEC”).

A.G.P./Alliance Global Partners is acting as the sole placement agent in connection with the offering.

The Series A and Series B preferred stock and shares of common stock into which these preferred shares are convertible are being issued in reliance upon the exemption from the securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the “1933 Act”) and/or Rule 506 of Regulation D as promulgated by SEC under the 1933 Act.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 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 expects to initiate a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is Phase 2 ready and has been granted Breakthrough Therapy Designation by the FDA. 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 second half of 2022. 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 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 second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent monkeypox and smallpox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox vector (RPV) live virus vaccine platform.

^*All of Tonix’s product
candidates are investigational new drugs or biologics and none have 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
investor.relations@tonixpharma.com 
(862) 799-8599

Olipriya Das, Ph.D.
(media)
Russo Partners
Olipriya.Das@russopartnersllc.com 
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com 
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released
June 22, 2022

Tonix Pharmaceuticals Announces
Publication of Paper in Pharmaceutics on the Enhancing Effect That Magnesium
Contributes to in vivo Intranasal Oxytocin Analgesia

June 21, 2022 7:00am EDT

Intranasal Oxytocin with
Magnesium Demonstrated Augmented Craniofacial Analgesia in an Animal Model

Enhanced Effect of Mg²⁺ is the Core Patented Technology of TNX-1900 for Migraine

TNX-2900 Orphan Drug Designated
Product for Prader-Willi Syndrome Also Contains Mg²⁺

Issued Patents Expected to
Provide Exclusivity Until 2036

CHATHAM, N.J., June 21, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced the publication of a paper, entitled “Impact of Magnesium on Oxytocin Receptor Function,” in the journal 
Pharmaceutics, that described results from a research team led by Professor David Yeomans¹. The paper includes data showing the enhancing effects of magnesium (Mg²⁺) on the activity of intranasal oxytocin in an animal model of craniofacial pain. The Mg²⁺ enhanced formulation of intranasal oxytocin is the basis for the Company’s TNX-1900² drug candidate in development to prevent migraine headaches in chronic migraineurs, and TNX-2900² which is in development to treat hyperphagia (over-eating) in adolescent and young adult patients with Prader-Willi syndrome. Professor Yeomans was the scientific founder of Trigemina, Inc. from which Tonix acquired rights to the Mg²⁺enhanced oxytocin technology. Professor Yeomans is a consultant to Tonix and the research described in the paper was funded in part by Tonix.

“This new paper further evidences the important role Mg²⁺ plays in the effect of oxytocin on pain reduction both in vitro and in vivo in an animal model of head pain,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Prior to this work, studies of intranasal oxytocin on pain yielded inconsistent results because the analgesic effect of oxytocin decreased with higher doses, a phenomenon called ‘high dose inhibition’ or colloquially, as an ‘inverted U’ shaped dose response. Professor Yeomans and his team have shown that adding Mg²⁺ to intranasal oxytocin reduces or eliminates the ‘high dose inhibition’, such that analgesia increases with higher doses of oxytocin. Consequently, we expect that the Mg²⁺ enhanced formulation of intranasal oxytocin in TNX-1900 and TNX-2900 may provide consistent effects to the extent that the Mg²⁺ component of the formulation reduces or eliminates the high dose inhibition and may also allow for using higher oxytocin doses.”

Professor Yeomans said, “Mg²⁺ levels modulate the affinity of oxytocin receptor for oxytocin 
in
vitro. We have now confirmed that at above physiological concentrations Mg²⁺ increases the activity of oxytocin for oxytocin receptor in vivo. Intranasal oxytocin with Mg²⁺ demonstrated augmented craniofacial analgesia in animal models. Critically, we have also demonstrated that, under test conditions, oxytocin has an ‘inverted U’ shaped dose response which Mg²⁺ can overcome, potentially allowing for the use of higher oxytocin doses. The potential clinical significance of these observations is that the formulation of oxytocin plus Mg²⁺ in Tonix’s TNX-1900 and TNX-2900 has the potential to enhance oxytocin efficacy for pain as well as for other uses.”

“Tonix is excited to develop Mg²⁺-enhanced formulation of intranasal oxytocin as a non-addictive treatment for migraine and craniofacial pain and for the treatment of Prader-Willi Syndrome,” added Dr. Lederman. “TNX-1900 will enter Phase 2 for prophylaxis of chronic migraine in the second half of 2022 and TNX-2900 is in development for treating hyperphagia in Prader Willi syndrome. The preclinical data that we have seen to date are promising and show that oxytocin, a natural hormone, is capable of blocking the release of the neurotransmitter calcitonin gene-related peptide (CGRP) in the brain coverings and trigeminal ganglia, thus potentially modulating a key step in the causation of migraine. It has been shown that intranasally delivered oxytocin selectively reaches the trigeminal ganglia with low systemic absorption. Overall, we believe that TNX-1900 has the potential to be a non-addicting, non-constipating and easy to administer alternative to opioids to treat migraine and craniofacial pain. We believe targeted delivery of oxytocin could translate into selective blockade of CGRP release in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more quickly reversible, in contrast to monthly or quarterly dosing, giving physicians and their patients greater control.”

About Intranasal Oxytocin

Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. Oxytocin is approved by the U.S. Food and Drug Administration (FDA) as Pitocin^®3, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor.  An intranasal form of oxytocin was marketed in the U.S. by Novartis to assist in the production of breast milk as Syntocinon^®4 (oxytocin nasal 40 units/ml), but the product was discontinued, and the New Drug Application (NDA) has been withdrawn.

About Migraine

Migraine is a neurological condition that manifests in throbbing headache, often on one side of the head, that lasts at least four hours. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light, strong smells, and loud noises⁵. Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually.⁶ Approximately 39 million Americans suffer from migraines and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month).⁶

About TNX-1900²

TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin and Mg²⁺ in development as a candidate for prophylaxis of chronic migraine and for the treatment of craniofacial pain, insulin resistance and related conditions. In 2020, TNX-1900 was acquired from Trigemina, Inc. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin and Mg²⁺ into the nose. It has been observed that low oxytocin levels in the body can lead to increase in migraine headache frequency, and that increased oxytocin levels can relieve migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels. Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal nerve cells which, when activated, release of CGRP which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in headache. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system⁸ resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting transmission of pain signals and the release of CGRP.⁹ Blocking CGRP release is a distinct mechanism compared with CGRP antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding¹⁰ as well as its effects on trigeminal neurons and craniofacial analgesic effects in animal models¹. Intranasal oxytocin has been well tolerated in several clinical trials in both adults and children
¹¹. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects which could potentially occur with systemic CGRP antagonists such as anti-CGRP antibodies¹². For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. Tonix has licensed technology from the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

About Prader
Willi Syndrome

Prader-Willi syndrome is a rare genetic disorder of failure to thrive in infancy and uncontrolled appetite and obesity in childhood and adulthood with no approved treatments available that occurs in approximately one in 15,000 births. Prader-Willi syndrome results in physical, mental and behavioral problems. A key feature of Prader-Willi syndrome in infants is a lack of suckling and poor muscle strength which leads to malnutrition and failure to thrive. However, paradoxically in children and adults, the key feature of Prader-Willi syndrome is a constant sense of hunger (hyperphagia), which leads to severe obesity. Intranasal oxytocin improves suckling in newborn animals but also suppresses feeding behaviors in adult animal models.  

About TNX-2900⁵

TNX-2900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin and Mg²⁺ in development as a candidate for treatment of hyperphagia in Prader-Willi syndrome. TNX-2900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin and Mg² into the nose. Tonix licensed technology to treat Prader Willi Syndrome and non-organic failure to thrive disease from Inserm (the French National Institute of Health and Medical Research). The licensing agreement was negotiated and signed by Inserm Transfert, the private subsidiary of Inserm, on behalf of Inserm, Aix-Marseille Université and Centre Hospitalier Universitaire of Toulouse. The co-exclusive license allows Tonix to expand its intranasal potentiated oxytocin development program to the treatment of Prader-Willi syndrome. The patents covering the technology are expected to provide market exclusivity for the co-licensees in the U.S. and Europe through 2031, which exclusivity could be extended after marketing authorization by a Supplemental Protection Certificate in Europe or a Patent Term Extension in the U.S., independent of other Tonix-held patents covering the formulation and oxytocin potentiation technologies for intranasal administration.

¹Bharadwaj VN, et al., Pharmaceutics. 2022; 14(5):1105. https://doi.org/10.3390/pharmaceutics14051105
²TNX-1900 and TNX-2900 are investigational new drugs and have not been approved for any indication.

³Pitocin^® is a trademark of Par Pharmaceutical, Inc.
⁴Syntocinon^® is a trademark of BGP Products Operations GmbH.
⁵https://www.mayoclinic.org/diseases-conditions/migraine-headache/symptoms-causes/syc-20360201
⁶Burch et al., Migraine:
Epidemiology, Burden, and Comorbidity, Neurol Clin 37 (2019) 631–649.

⁷Yeomans, DC et al. 2017. US patent US2017368095.
⁸Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388.
⁹Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
¹⁰Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4.

¹¹Cai Q, et al., Psychiatry Clin Neurosci. 2018. Mar;72(3):140-151.
¹²MaassenVanDenBrink A, et al. Trends Pharmacol Sci. 2016. 37(9):779-788.

About 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 expects to initiate a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is Phase 2 ready and has been granted Breakthrough Therapy Designation by the FDA. 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 second half of 2022. 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 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 second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent monkeypox and smallpox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox vector (RPV) live virus vaccine platform.

^*All of Tonix’s product candidates are investigational new drugs
or biologics and none have 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
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

OCUGEN ANNOUNCES PUBLICATION OF POSITIVE RESULTS OF COVID-19 VACCINE TRIAL FOR CHILDREN 2-18 IN THE LANCET INFECTIOUS DISEASES

June 21, 2022

Ocugen’s partner Bharat Biotech’s Phase 2/3 study of COVAXIN™ (BBV152) in 526 children showed safety, efficacy, and superior response to that shown in adults

Ocugen has North American commercialization rights for COVAXIN™

MALVERN, Pa., June 21, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals, and vaccines, today announced the publication of positive pediatric Phase 2/3 study results in children aged 2–18 years for the COVID-19 vaccine COVAXIN™ (BBV152) in The Lancet Infectious Diseases (“The Lancet”). COVAXIN™ is developed and manufactured by Ocugen’s partner Bharat Biotech International Limited (“Bharat Biotech”), a global leader in vaccine innovation based in Hyderabad, India, and is under clinical investigation by Ocugen in the United States for use in adults aged 18 years and older.

The Lancet article, entitled “Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2–18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study,” which was authored by Dr. Krishna Mohan Vadrevu, Siddharth Reddy, MSc, and others, was published on June 16, 2022.

Ocugen has commercial rights for COVAXIN™ throughout North America and COVAXIN™ has emergency use authorization in Mexico for adults. Ocugen is continuing to explore pediatric emergency use authorization in Mexico. This data demonstrates that the same dose is effective in both pediatrics and adults (ages two and older) and would be an ideal option as the majority of Americans are looking for traditional vaccine options. Ocugen is continuing its effort to bring this vaccine to the North American Market.

“We congratulate Bharat Biotech on the publication of the COVAXIN™ pediatric data in this prestigious peer-reviewed medical journal,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen. “Not only is this a strong validation of the work they are doing, but it is a very encouraging development in the effort to contain this pandemic, which needs a greater variety of vaccine options to combat the multiple COVID-19 variants. We believe the distinct features of COVAXIN™ offer benefits that could help improve public health.”

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “We are glad to have Ocugen as a valuable partner to help bring COVAXIN™ to North America. Safety of the vaccine is critical for children, and we are glad to share that COVAXIN™ has proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children, for primary immunization and booster doses, making COVAXIN™ a universal vaccine. It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India.”

The low reactogenicity might make COVAXIN™ more acceptable in pediatric populations than the more reactogenic mRNA vaccines as Bharat Biotech’s pediatric Phase 2/3 study had no serious adverse events, deaths, or withdrawals due to an adverse event including no cases of Guillain-Barré syndrome, thromboembolic events, myocarditis, or pericarditis, or other adverse events of special interest being observed to date. We believe COVAXIN™ will be a valuable tool in the global immunization effort as it can be stored at 2–8°C, which is standard vaccine storage conditions. Follow-up studies to assess pediatric effectiveness are underway, but this study suggests that similar efficacy, measured by the ability of a vaccine to prevent disease, might be anticipated in children based on the observation of superior immunogenicity, measured by the ability of a vaccine to produce an immune response, as compared to adults.

The open-label, non-randomized study was conducted in six hospitals in India and included 526 healthy children. Two doses of COVAXIN™ were administered 28 days apart in three groups according to their ages, two to six years, six to 12 years, and 12 to 18 years. The results were compared with those from adults who participated in a previously reported Phase 2 study. The study is registered with the Clinical Trials Registry, India (CTRI/2021/05/033752) and ClinicalTrials.gov (NCT04918797).

About COVAXIN™ (BBV152)
The COVID-19 vaccine candidate BBV152, known as COVAXIN™ outside the United States, is a whole-virion inactivated COVID-19 vaccine candidate that applies the same Vero cell manufacturing platform, which has been used in the production of polio vaccines for decades. COVAXIN™ was co-developed with Ocugen’s partner, Bharat Biotech, in collaboration with the Indian Council of Medical Research – National Institute of Virology. COVAXIN™ has been granted Emergency Use Listing by the World Health Organization based on a submission by Bharat Biotech. COVAXIN™ is formulated uniquely such that the same dosage can be administered to adults and children alike, making it truly a universal vaccine. COVAXIN™ is a ready to use liquid vaccine stored at 2-8°C with a 12-month shelf life and multi dose vial policy.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals, and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include, but are not limited to, statements about COVAXIN™ efficacy, safety, and immunogenicity in children aged 2-18 years, Ocugen’s ability to expand emergency use authorization for COVAXIN™ in Mexico to include children aged 2-18 years, Ocugen’s intention to continue its effort to bring COVAXIN™ to the North American Market, and the potential advantages of COVAXIN™ over other vaccines. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contacts:
Tiberend Strategic Advisors, Inc.
Jonathan Nugent / Daniel Kontoh-Boateng (Investor Relations)
jnugent@tiberend.com
dboateng@tiberend.com

Bill Borden (Media)
bborden@tiberend.com

Tuesday, June 21, 2022

Avivagen Inc. (VIVXF)
Waiting for Upturn in End Markets

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.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Q2 Results. Avivagen reported revenue of $88,438 (all figures are in Canadian $), down from $159,614 the prior year and below our estimate of $400,000. Net loss for the quarter was at $1.3 million or $0.02 per share, an increase over the prior year’s $2.2 million or $0.04 per share, and better than our estimate of a loss of $1.4 million or $0.03 per share. The decrease in revenue was due to lower sales of OxC-Beta, with the net loss decrease due to an adjustment on the Company’s ACOA liabilities.

Modest OxC-beta Sales. During 2Q22, Avivagen sold just 925 kilograms of OxC-beta Livestock, down from 2,550 kg in 1Q22. Nearly half, or 400 kgs, was sold in Brazil, Other sales were made in Thailand, 150 kgs, Taiwan, 350 kgs, and Mexico, 25 kgs. The average price of OxC-Beta per kilogram was $102.27 in the quarter from a previous $106.33 in 1Q22….

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. 

Tonix Pharmaceuticals Announces Ribbon-Cutting Ceremony for its Advanced Development Center (ADC) for Vaccine Programs in Massachusetts

Research, News, and Market Data on Tonix Pharmaceuticals

The ADC is
Expected to Accelerate Clinical-Scale Manufacturing of Live Virus Vaccines,
Including Vaccines for Monkeypox, Smallpox and COVID-19

Internal Manufacturing
Capabilities Expected to Support U.S. Pandemic Preparedness

CHATHAM, N.J., June 16, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it will hold a ribbon-cutting ceremony at the Company’s 45,000 square foot clinical-scale manufacturing facility in the New Bedford Business Park in North Dartmouth, Massachusetts on June 21, 2022 at 1:00 pm ET. The new facility houses Tonix’s Advanced Development Center (ADC) for accelerated research, development and analytical capabilities, as well as the production of clinical trial quality vaccines for infectious diseases, including monkeypox, smallpox and COVID-19 as well as other infectious diseases for pandemic preparedness. The ceremony marks the formal opening of the New Bedford site.

U.S. Representative Bill Keating; the mayor of New Bedford, Mass., Jon Mitchell; Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals; and other prominent community members and employees plan to attend the event.

The ADC includes single-use bioreactors and purification suites with equipment for Good Manufacturing Practice (GMP) production of vaccines for clinical trials, including the capability of producing sterile vaccines in glass bottles. The ADC is Biosafety Level 2 (BSL-2). At full capacity, the facility can employ up to 70 researchers, scientists, manufacturing and technical support staff.

“Tonix Pharmaceuticals is making good on their promise to bring jobs to the New Bedford area, and we should be proud to host this new facility that has the potential to impact lives all over the world,” said Congressman Bill Keating. “Thanks to the hard work of Tonix, the town of Dartmouth and City of New Bedford, this facility opening further cements the role that the South Coast is playing in biotech. The continued private and public sector investments in our region are paying dividends, and the ribbon-cutting for this facility serves as yet another positive indicator of continued economic growth on the South Coast.”

“The addition of Tonix Pharmaceuticals to the growing biotech community in Greater New Bedford is a strong indicator of the quality of the region’s workforce. We have the talent to compete in a variety of sectors,” said Jon Mitchell, Mayor of the City of New Bedford.

“The opening of our new manufacturing facility in the New Bedford Business Park is a significant milestone for Tonix and we are excited to be part of the growing biotech industry in the South Coast region of Massachusetts,” stated Dr. Lederman. “The ADC greatly enhances our ability to progress our pipeline of vaccines for infectious diseases, including monkeypox, smallpox and COVID-19. We believe that the recombinant pox virus platform technology underlying our key vaccines in development, TNX-801, TNX-1840 and TNX-1850, coupled with our capabilities at the Tonix R&D Center (RDC) for research and development, will be rapidly deployable for addressing potential novel or emerging pathogens, with simplified distribution and administration, relative to modified mRNA-based vaccines. Our goal is to be able to design and test new recombinant pox virus vaccines against novel pathogens within the 100 days of recognition of a potential emerging pandemic threat, consistent with the criteria set forth by the White House Office of Science and Technology Policy. With high quality people, systems and processes, we intend to be a center of excellence for vaccine development.”

The facility is located in the New Bedford Business Park in a section of the park that is located in the Town of Dartmouth, Massachusetts. The two municipalities work together to accommodate businesses located in the Dartmouth portion of the park as the roads are inaccessible through Dartmouth and municipal services are provided by the City of New Bedford.

Tonix
Pharmaceuticals Holding Corp.¹

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 expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that Phase 2 ready and has been granted Breakthrough Therapy Designation by the FDA. 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 second half of 2022. 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 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 second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

¹All 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
investor.relations@tonixpharma.com

(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com

(646) 942-5588

Peter Vozzo (investors)
Westwicke/ICR

peter.vozzo@westwicke.com

(443) 213-0505

Ocugen, Inc. Announces Issuance of U.S. Patent for Treating Retinal Degenerative Diseases Using Gene Therapy

Research, News, and Market Data on Ocugen

ISSUANCE OF U.S.
PATENT NO. 11,351,225 FURTHER ENHANCES OCUGEN’S GENE THERAPY INTELLECTUAL
PROPERTY PORTFOLIO

MALVERN, Pa., June 13, 2022 (GLOBE NEWSWIRE) — Ocugen,
Inc. (NASDAQ:OCGN), a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals, and vaccines, today announced that on June 7, 2022, the United States Patent and Trademark Office (“USPTO”) issued U.S. Patent No. 11,351,225, which is directed to methods for preventing or treating an ocular disease or disorder associated with a retinal degenerative disease.

U.S. Patent No. 11,351,225 (the “‘225 Patent”) covers the use of a nuclear hormone receptor gene, such as NR2E3, RORA, NUPR1, and 
NR2C1, in treating retinal degenerative diseases as well as reducing the risk of developing such diseases. Additional issued claims pertain to using a nuclear hormone receptor gene to treat retinitis pigmentosa, age-related macular degeneration, and inherited retinal degenerative diseases. The ‘225 Patent contains 18 claims and expires in March 2034.

“We are pleased to have been granted this new U.S. patent through our exclusive license agreement with The Schepens Eye Research Institute, an affiliate of Harvard Medical School. We believe this patent significantly validates our modifier gene therapy platform developed by Dr. Neena Haider and augments our growing global patent portfolio,” commented Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.

This newly allowed patent is exclusive to Ocugen and is the latest U.S. patent issued in connection with Ocugen’s gene therapy program for treating retinal degenerative diseases.

About Ocugen,
Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

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

Contact
Tiberend
Strategic Advisors, Inc.
Jonathan Nugent / Daniel Kontoh-Boateng (Investors)
jnugent@tiberend.com
dboateng@tiberend.com

Dave Schemelia (Media)

dschemelia@tiberend.com