Wednesday, July 20, 2022

The GEO Group (GEO)
Maturity Wall Removed, But at What Cost?

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 103 facilities totaling approximately 83,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

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.

Maturity Wall. The GEO Group has entered into a series of proposed transactions with certain of its secured and unsecured creditors that will, if completed, comprehensively address the substantial majority of the Company’s debt maturity wall. This should remove a significant near-term concern of investors and GEO shares reacted as expected, rising 8.50% yesterday.

Details. Recall, GEO has $278 million of debt payments in 2023 and $1.77 billion of repayments in 2024. Although the operating environment has turned favorable, limited capital markets access makes it unlikely GEO would be able to refinance the debt as it came due. The proposed transactions push the maturity wall out far enough that we believe GEO should be able to successfully refinance any debt that remains outstanding….

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. 

Monday, July 18, 2022

Filament Health (FLHLF)
Patient Dosing Has Begun in Phase I Psilocin Trial, Seventh Patent Issued, and New Funds Raised

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Recent Progress Has Been Made In Several Areas.  Filament Health has announced the dosing of the first patient in the Phase 1 trial testing orally administered psilocybin against its two formulations of psilocin.  This trial will compare psilocybin with two proprietary formulations of psilocin, its active metabolite.  The company has also announced the issuance of its seventh patent and raised $2.5 million through a Private Placement.

The trial is being conducted at the University of San Francisco’s Translational Psychedelic Research Program (TrPR), a collaboration of academic scientists and clinicians from several medical specialties that are exploring the use of psychedelic compounds as therapeutics.  The clinical trial consists of three dosing arms, with patients receiving the orally administered formulation of psilocybin, PEX010, the orally administered formulation of psilocin, PEX020, or the sublingual formulation, PEX030.  The study will compare the physiological and psychological effects of the three formulations, dosing consistency, and the related side-effects….

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. 

Monday, July 18, 2022

MustGrow Biologics Corp. (MGROF)
A Healthier Way to Grow and Preserve the Food Supply

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.

Initiating Coverage. We are initiating coverage of MustGrow Biologics Corp. with a Market Perform rating. MustGrow is an agtech company with a natural, organic technology platform that has proved highly efficacious in controlling microbial diseases, pests, and weeds. The Company ‘s patented technology has undergone over 110 independent studies confirming its abilities.

A Greener Way. MustGrow harnesses the mustard seed’s natural defense mechanism as the base for its product. MustGrow’s active ingredient possesses several benefits including sustainability, positive soil health, and minor ecological impact. The product has the potential to be priced competitively with conventional alternatives.…

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

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

Image Credit: CDC (Pexels)

Is Biotech’s Outperformance Reaching a New Stage of Development?

The biotech investment sector has always been its own market, very distinct from other sectors. So it was no surprise that when most sectors turned slowly upward after the pandemic-inspired crash, Biotech (XBI) rose 164%, exceeding the overall market (SPY) performance by triple digits. Then, about 11 months from biotech’s launch to the stratosphere, it took its own path downward even though the overall market continued upward for another 11 months. In recent weeks the overall market has been trading sideways after hitting a YTD low on June 16^th. Over the same short period, the biotech sector has gained double-digits.

This past June 13^th, the SPDR biotech ETF formed a technical double bottom (May 11/Jun 13) and has since risen near 30% in one month’s time. It was obvious what drove these stocks higher during the pandemic. The enthusiasm for modern medicine was at a peak with the news on most people’s minds each day. But what is driving this sector’s heights now, and will it continue? 

What’s Happening

Since the start of the current upturn on June 13, the XBI is up 28.4%, after biotech’s period of being among the most beaten down sectors most of the year. The XBI would still have to rise by another 25% to reach breakeven on the year. Some investors think that its slide was overdone and are now allocating more to the biotech sector.

Source: Koyfin

In a note on Thursday (July 14), Piper Sandler analyst Christopher Rayment said $1.1 billion in net new money, the second-highest total this year, flowed into funds focused on healthcare and biotech for the week ended July 6. One catalyst for the increase could be reports from The Wall Street Journal that Merck (MRK) may be involved in a $40 billion purchase of the biotech Seagen (SGEN), a cancer-focused drugmaker. Also, the FDA approval scientists are less bogged down with pandemic-related entries and can begin to move forward, business as usual, with their approval studies.

The Seagen deal could further increase investor interest in the sector as the Merck name will likely keep it in the headlines. And perhaps it is time that biotechs regain attention, they are far cheaper than they have been in years.

Recent biotech deals receiving less attention are:

• La Jolla Pharmaceuticals (LJPC) on July 11, acquired by Innoviva at an 84% premium
• Epizyme (EPZM) on June 27, acquired by Ipsen at a 53% premium
• F Star Therapeutics (FSTX) on June 23, acquired by invoXPharma at a 122% premium
• TherapeuticsMD (TXMD)on May 31, acquired by EW Healthcare Partners at a 367% premium

The pace of acquisitions, just past the halfway point of the year, is running above the previous four years. The category impacted most often in each of the five periods is oncology.

* The data is limited to deals valued at a minimum of $50 million upfront. Total consideration can reflect both cash and equity offered upfront in exchange for the acquired company’s shares, but deals in which the upfront payment was not specified, or was less than $50 million, are not included.

Since the June 13 turn upward, other companies in this space that generated double-digit returns for shareholders, near or above XBI are:

• Imugene (IUGNF) up 53.7%
• PDS Biotechnology (PDSB) up 33.4%
• Ocugen (OCGN) up 27.5%
• Lineage Cell Therapeutics (LCTX)up 19.2%

Source: Koyfin

Take Away

The biotech sector is not highly correlated with the overall market. During periods of market weakness, it is a good idea to look at less-correlated sectors to determine if there is relative strength and opportunity.

Biotech investors often look to a company’s pipeline to determine where it may be in developmental stages to determine if a valuation-changing breakthrough could be near. Astute investors also try to find gains by investing in companies with the potential of being acquired. The current scenario where huge pharmaceutical companies are sitting with cash at very high valuations, and biotech firms have been beaten down, creates a recipe for increased mergers and acquisitions. Also, many biotechs that rely on capital raises to get them through the long R&D or approval stage find it more difficult to raise capital when their stock trades very low. These companies with a worthwhile pipeline are now very attractive to large better-capitalized companies. For the small biotech companies, they may be more willing than ever to be acquired to keep their treatment development on track.

In the business of drug development, deals are as important as medical breakthroughs. Many of today’s most influential medicines might not have made it to the finish line without a timely partnership or acquisition.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://app.koyfin.com/share/dd2a65e582

https://www.thestreet.com/investing/cathie-wood-ark-buys-biotech

https://www.wsj.com/articles/merck-is-in-advanced-talks-to-buy-seagen-11657160827

https://www.wsj.com/articles/merck-eyes-purchase-of-biotech-seagen-11655476223?mod=article_inlin

https://www.pipersandler.com/2col.aspx?id=7&analystid=2284

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Cocrystal Pharma Reports CC-42344 Pharmacokinetic Data in Influenza A Once-Daily Dosing

Research, News, and Market Data on Cocrystal Pharma

Single Ascending Dose Portion
of Phase 1 Study Completed

BOTHELL, Wash., July
14, 2022 (GLOBE NEWSWIRE) — Cocrystal
Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that pharmacokinetic (PK) data from the single ascending dose portion of a Phase 1 study with its novel, broad-spectrum, orally administered antiviral candidate 
CC-42344 for the treatment of pandemic and seasonal influenza A support the potential for once-daily dosing. The single ascending dose portion of the Phase 1 study has been completed and subjects are currently being enrolled in the multiple ascending dose portion of the Phase 1 study.

“The PK data from single ascending dose portion of the trial mark a major milestone in the development of CC-42344’s as our drug holds potential to be administered once a day, less frequently than the leading influenza treatment Tamiflu^®,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “Unlike the mechanism of action of existing influenza A treatments, CC-42344 is a PB2 inhibitor that blocks an essential step of influenza viral replication and transcription. Completed in vitro testing demonstrated potent antiviral activity against prevalent influenza A strains resistant to the two approved influenza treatments Tamiflu^® and Xofluza^®.”

The randomized, double-controlled, dose-escalating Phase 1 study being conducted in Australia is intended to assess the safety, tolerability and pharmacokinetics of 
CC-42344 in healthy adults. In March 2022 Cocrystal announced the initiation of study enrollment and in April 2022 the Company announced preliminary Phase 1 data demonstrating a favorable safety and PK profile in the first two cohorts administered single ascending doses of 100 mg and 200 mg.

About Cocrystal
Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note
Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential for CC-42344 to be developed for once-daily use and possible advantages over competitive treatments of influenza. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the availability of federal government funding and budgetary issues that may arise, the risks and uncertainties arising from any future impact of the COVID-19 pandemic including in Australia, the Russian invasion of Ukraine, and/or inflation and Federal Reserve interest rate increases in response thereto on the global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, the ability of the contract research organization to recruit patients into clinical trials, and the results of the multiple ascending dose portion of the Phase 1 study for CC-42344. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2021. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100

jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378


Jabraham@jqapartners.com

Image Credit: Piction health (MIT News)

Startup Lets Doctors Classify Skin Conditions with the Snap of a Picture

Zach Winn | MIT News Office

At the age of 22, when Susan Conover wanted to get a strange-looking mole checked out, she was told it would take three months to see a dermatologist. When the mole was finally removed and biopsied, doctors determined it was cancerous. At the time, no one could be sure the cancer hadn’t spread to other parts of her body — the difference between stage 2 and stage 3 or 4 melanoma.

Thankfully, the mole ended up being confined to one spot. But the experience launched Conover into the world of skin diseases and dermatology. After exploring those topics and possible technological solutions in MIT’s System Design and Management graduate program, Conover founded Piction Health.

Piction Health began as a mobile app that used artificial intelligence to recognize melanoma from images. Over time, however, Conover realized that other skin conditions make up the vast majority of cases physicians and dermatologists see. Today, Conover and her co-founder Pranav Kuber focus on helping physicians identify and manage the most common skin conditions — including rashes like eczema, acne, and shingles — and plan to partner with a company to help diagnose skin cancers down the line.

“All these other conditions are the ones that are often referred to dermatology, and dermatologists become frustrated because they’d prefer to be spending time on skin cancer cases or other conditions that need their help,” Conover says. “We realized we needed to pivot away from skin cancer in order to help skin cancer patients see the dermatologist faster.”

After primary care physicians take a photo of a patient’s skin condition, Piction’s app shows images of similar skin presentations. Piction also helps physicians differentiate between the conditions they most suspect to make better care decisions for the patient.

Conover says Piction can reduce the time it takes physicians to evaluate a case by around 30 percent. It can also help physicians refer a patient to a dermatologist more quickly for special cases they’re not confident in managing. More broadly, Conover is focused on helping health organizations reduce costs related to unnecessary revisits, ineffective prescriptions, and unnecessary referrals.

So far, more than 50 physicians have used Piction’s product, and the company has established partnerships with several organizations, including a well-known defense organization that had two employees diagnosed with late-stage melanoma recently after they couldn’t see a dermatologist right away.

“A lot of people don’t realize that it’s really hard to see a dermatologist — it can take three to six months — and with the pandemic it’s never been a worse time to try to see a dermatologist,” Conover says.

 

Shocked into Action

At the time of Conover’s melanoma diagnosis, she had recently earned a bachelor’s degree in mechanical engineering from the University of Texas at Austin. But she didn’t do a deep dive into dermatology until she needed a thesis topic for her master’s at MIT.

“It was just a really scary experience,” Conover says of her melanoma. “I consider myself very lucky because I learned at MIT that there’s a huge number of people with skin problems every year, two-thirds of those people go into primary care to get help, and about half of those cases are misdiagnosed because these providers don’t have as much training in dermatology.”

Conover first began exploring the idea of starting a company to diagnose melanoma during the Nuts and Bolts of Founding New Ventures course offered over MIT’s Independent Activities Period in 2015. She also went through the IDEAS Social Innovation Challenge and the MIT $100K Entrepreneurship Competition while building her system. After graduation, she spent a year at MIT as a Catalyst Fellow in the MIT linQ program, where she worked in the lab of Martha Gray, the J.W. Kieckhefer Professor of Health Sciences and Technology and a member of MIT’s Institute for Medical Engineering and Science (IMES).

Through MIT’s Venture Mentoring Service, Conover also went through the I-Corps program, where she continued to speak with stakeholders. Through those conversations, she learned that skin rashes like psoriasis, eczema, and rosacea account for the vast majority of skin problems seen by primary care physicians.

Meanwhile, while public health campaigns have focused on the importance of protection from the sun, public knowledge around conditions like shingles, which effects up to 1 percent of Americans each year, is severely lacking.

Although training a machine-learning model to recognize a myriad of diverse conditions would be more difficult than training a model to recognize melanoma, Conover’s small team decided that was the best path forward.

“We decided it’s better to just jump to making the full product, even though it sounded scary and huge: a product that identifies all different rashes across multiple body parts and skin tones and age groups,” Conover says.

The leap required Piction to establish data partnerships with hundreds of dermatologists in countries around the world during the pandemic. Conover says Piction now has the world’s largest dataset of rashes, containing over 1 million photos taken by dermatologists in 18 countries.

“We focused on getting photos of different skin tones, as many skin tones are underrepresented even in medical literature and teaching,” Conover says. “Providers don’t always learn how all the different skin tones can present conditions, so our representative database is a substantial statement about our commitment to health equity.”

Conover says Piction’s image database helps doctors evaluate conditions more accurately in primary care. After a provider has determined the most likely condition, Piction presents physicians with information on treatment options for each condition.

“This front-line primary care environment is the ideal place for our innovation because they care for patients with skin conditions every day,” Conover says.

 

Helping Doctors at Scale

Conover is constantly reminded of the need for her system from family and friends, who have taken to sending her pictures of their skin condition for advice. Recently, Conover’s friend developed shingles, a disease that can advance quickly and can cause blindness if it spreads to certain locations on the body. A doctor misdiagnosed the shingles on her forehead as a spider bite and prescribed the wrong medication. The shingles got worse and caused ear and scalp pain before the friend went to the emergency room and received the proper treatment.

 

“It was one of those moments where we thought, ‘If only physicians had the right tools,’” Conover says. “The PCP jumped to what she thought the problem was but didn’t build the full list of potential conditions and narrow from there.”

Piction will be launching several additional pilots this year. Down the line, Conover wants to add capabilities to identify and evaluate wounds and infectious diseases that are more common in other parts of the world, like leprosy. By partnering with nonprofit groups, the company also hopes to bring its solution to doctors in low-resource settings.

“This has potential to become a full diagnostic tool in the future,” Conover says. “I just don’t want anyone to feel the way I felt when I had my first diagnosis, and I want other people like me to be able to get the care they need at the right time and move on with their lives.”

Reprinted with permission of MIT News” and a link to the MIT News homepage ( http://news.mit.edu/)

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Tonix Pharmaceuticals Announces Development of TNX-601 ER, a Potential Abuse Deterrent, Extended-Release Formulation of Tianeptine Oxalate for the Treatment of Major Depressive Disorder

Research, News, and Market Data on Tonix Pharmaceuticals

Naloxone-Free
Formulation of Tianeptine is an Extended-Release Tablet that Includes Inactive
Ingredients and Compression Properties Designed to Confer Abuse Deterrence

Once-Daily Tablet Formulation
of Tianeptine is Bioequivalent to the Three Times a Day Antidepressant Marketed
in Europe for Over 30 years

Tianeptine’s Enhancement of
Neuroplasticity in Animal Models of Stress Implies a Distinct Indirect
Glutamatergic Mechanism of Action Relative to Antidepressants Marketed in the
U.S.

Planning to Initiate Enrollment
in U.S. Phase 2 Study in First Quarter 2023, Pending FDA Clearance of IND

CHATHAM, N.J., July 11, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced development of TNX-601 ER (tianeptine oxalate extended-release tablets), a naloxone-free formulation of TNX-601 designed to confer abuse-deterrence, for the treatment of major depressive disorder (MDD)¹. Tonix expects to initiate a Phase 2 study of TNX-601 ER for the treatment of MDD in the first quarter of 2023, pending U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application.

Tonix’s TNX-601 ER is being developed as a treatment for MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (IR) tablets have been available in Europe and many countries in Asia and Latin America for the treatment of MDD over the more than three decades since it was first marketed in France in 1989. No tianeptine-containing product has been approved by the FDA. The proposed mechanism of action of TNX-601 ER is distinct from traditional monoaminergic antidepressants in the U.S. In addition to its glutamatergic properties central to its antidepressant effect, tianeptine has weak µ-opioid receptor agonist properties and has been linked to illicit misuse at much higher doses than those reported to be effective in the treatment of MDD². Previously, Tonix was developing a naloxone-containing tablet, TNX-601 CR (tianeptine oxalate and naloxone controlled-release) for MDD, that was designed to mitigate the risk of parenteral abuse.

“TNX-601 ER is a naloxone-free tablet formulated with inactive ingredients that we believe will make the tablet more difficult to adulterate for misuse and abuse, while maintaining extended-release characteristics, even if the tablet is subjected to physical manipulation, and/or chemical extraction,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “The potentially abuse deterrent ingredients include gel forming polymers which impede extraction, and excipients which cause nasal irritation. In addition, the tablet’s hardness makes it difficult to crush, cut or grind to fine particle size, which hinders efforts to misuse by insufflation or intravenous routes.”

“The efficacy of tianeptine sodium IR is comparable to both selective serotonin inhibitor (SSRI) and tricyclic antidepressants
^3,4 while being associated with a low incidence of sexual dysfunction than either of those classes^5,6, and no associated derangement of sleep architecture, sedation effects, weight gain, or cognitive impairment,⁷” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Given tianeptine’s unique metabolic pathway, which is independent of the hepatic P450 system, we believe that TNX-601 ER has a reduced risk of drug-drug interactions compared to most antidepressants⁷. Tianeptine’s antidepressant activity is believed to relate to indirect modulation of the glutamatergic system. While it does not have measurable interactions with the NMDA, AMPA or kainate receptors, tianeptine is known to modulate AMPA receptor trafficking and to promote synaptic plasticity in hippocampus under conditions of stress or corticosteroid use. In animal models, tianeptine restores neuroplasticity and reverses stress-induced impairments in synaptic glutamate neurotransmission, which are perturbed in depression.⁸ Additionally, TNX-601 ER is designed for once daily dosing, which is believed to provide an adherence advantage relative to the three times per day dosing of the immediate-release sodium salt products available in Europe and other jurisdictions around the world.”

¹TNX-601 ER is in the pre-IND (Investigational New Drug) stage of development and is not approved for any indication

²Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–553.

³Jeon, H. J., et al. .J. Clin. Psychopharmacol. 2014, 34 (2), 218–225.

⁴Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
⁵Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.
⁶Costa e Silva, J. A., et al. Neuropsychobiology 1997, 35 (1), 24–29.

⁷Wagstaff, A. J. et al. CNS
Drugs 2001, 15 (3), 231–259.

⁸McEwen, B. S., et al. Mol.
Psychiatry 2010, 15 (3), 237–249.

About Depression
According to the National Institute of Mental Health, an estimated 21 million adults in the U.S. in 2020 experienced at least one major depressive episode¹, with highest prevalence among individuals aged 18-25 at a rate of 17.0%. For approximately 2.5 million adults in the U.S., adjunctive therapies are necessary for depression treatment.^2,3 Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behaviors. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.⁴

¹Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults (2020). Retrieved from 
http://www.nimh.nih.gov/health/statistics/major-depression.shtml
²IMS NSP, NPA, NDTI MAT-24-month data through Aug 2017.
³Kubitz N, et al. (2013)  PLOS One,. 8(10):e76882. doi: 10.1371/journal.pone.0076882. PMID: 24204694;
⁴Rush AJ, et al. (2007) Am J.
Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).

About TNX-601 ER
TNX-601 ER is a novel oral formulation of tianeptine oxalate designed for once-daily daytime dosing that is in the pre-IND (Investigational New Drug) stage of development for the treatment of MDD. Tonix reported the official minutes of an FDA Pre-IND meeting on March 22, 2021. Tianeptine sodium (amorphous) immediate release (3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently there is no tianeptine-containing product approved in the U.S. and no extended-release tianeptine product approved in any jurisdiction. Tonix discovered a novel oxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine. Tianeptine is believed to work in depression as an indirect modulator of the glutamatergic system, without direct binding NMDA, AMPA or kainate receptors. Tianeptine reverses stress induced increases in AMPA receptor trafficking, restoring hippocampal long-term potentiation and reversing the neuroplastic changes from stress and corticosteroid exposure. Tianeptine and its MC5 metabolite are also weak mu-opioid receptor (MOR) agonists, that present a potential abuse liability if illicitly misused in large quantities (8-80 times the therapeutic dose). In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated¹ suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine does not appear to result in dependence or withdrawal symptoms following 6-weeks^2,3,4–6, 3-months⁷, or 12-months⁸ of treatment. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder. TNX-601 ER is expected to have patent protection through 2037.   

¹Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.

²Emsley, R., et al. J. Clin.
Psychiatry 2018, 79 (4)
³Bonierbale M, et al. Curr Med
Res Opin 2003, 19(2):114-124.⁴Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.

⁵Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.

⁶Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.

⁷Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.

⁸Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, No. 15, 61–65.

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. TNX-601 ER (tianeptine oxalate extended-release tablet) is being developed as an antidepressant in the U.S., with a Phase 2 study expected to be initiated in first quarter of 2023 pending IND clearance. 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

 

Source: Tonix Pharmaceuticals Holding Corp.

Monday, July 11, 2022

Ortho Regenerative Technologies Inc. (ORTIF)
Heal Better; Initiating Coverage with an Outperform Rating

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.

Unmet large market needs. Ortho Regenerative Technologies Inc. (Ortho RTI) is advancing its RESTORE regenerative medicine platform in rotator cuff tears and meniscus tears to improve healing. Rotator cuff and meniscus tears have high failure rates due to insufficient healing and tissue degeneration. For these two indications, Ortho RTI has a $1.8 billion US market opportunity. Globally, the market opportunity more than doubles. Additional future applications expand the opportunity further.

Safe and easy to produce. The proprietary RESTORE platform is a biopolymer matrix technology combining readily available chitosan, derived principally in shellfish, with autologous platelet-rich plasma (PRP). Using the patient’s own plasma substantially improves the safety profile while the chitosan provides site “stickiness”.

…

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. 

Friday, July 08, 2022

BioSig Technologies (BSGM)
BioSig Scores a Big Win

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.

Purchase agreement announcement. Yesterday, BioSig Technologies announced a purchase and leasing agreement with Kansas City Heart Institute at Overland Park Regional Medical Center. While terms were not disclosed, Kansas City Heart has multiple EP labs that could benefit from the PURE EP signal processing technology.

National master agreement also announced. Concurrent with the Kansas City Heart commercial announcement, BioSig also announced a national purchase agreement. While not named in the release, it is likely the master was signed with HCA Healthcare given that Kansas City Heart Institute is part of the HCA Midwest Heart and Vascular group. One of the largest hospital networks with 175 general and acute hospitals, HCA represents a substantial opportunity moving forward.…

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. 

BioSig Announces Purchase Agreement with Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center

News and Market Data on BioSig Technologies

Westport, CT, July 07, 2022 (GLOBE NEWSWIRE) —

• OPRMC marks our first leasing
  agreement under new program

• Company also inks national
  master agreement with one of the largest U.S. healthcare systems

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today announced that Kansas City Heart Institute at Overland Park Regional Medical Center in Kansas City, U.S. has signed a purchase agreement to acquire its PURE EP(T.M.) System. 

Following its evaluation of BioSig’s PURE EP(T.M.) System, Overland Park Regional Medical Center (OPRMC) has signed an agreement to purchase the technology under the terms of the Company’s new program. The agreement represents BioSig’s first commercial adoption since it announced the national launch of its PURE EP ™ System, supported by The Company’s new commercial structure and clinical support teams. The agreement also represents The Company’s first national purchasing agreement.

“Establishing a contract with a leading national hospital network is a milestone achievement for BioSig Technologies,” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc. “A leasing option provides a cost-effective and efficient pathway for hospitals to acquire our technology. As a Company that prioritizes physician experience and throughput, we believe a leasing program supports the clinical evolution of PURE EP as we continue upgrading and enhancing our technology based on physician feedback.” 

“We are pleased to announce our first purchase agreement since we transformed the commercial capabilities under new management,” said Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. “The Company is excited about our clinical collaboration with Dr. Lakkireddy and the physician faculty at Overland Park. As physician advocates, we are proud of our commitment to and alignment with the world-class arrhythmia program at Kansas City Heart Rhythm Institute and thank them for their continued support of our technology.”

“This technology will be an instrumental part of Kansas City Heart Rhythm Institute’s continued quest to provide superior world class care for patients,” says Executive Medical Director for the Kansas City Heart Rhythm Institute and Professor of Medicine at the University of Missouri Columbia and University of Nevada Las Vegas and Chief of Electrophysiology at Overland Park Medical Center, Dhanunjaya DJ Lakkireddy, MD. “This technology could potentially enhance our ability to improve efficacy and safety of heart rhythm procedures and thereby positively impact workflow and subsequently, patient outcomes.”

 

About Kansas City Heart
Rhythm Institute

The Kansas City Heart Rhythm Institute at the HCA Midwest Health Heart and Vascular Institute brings the highest quality clinical care, research and arrhythmia education to Kansas City. There are eight practicing Electrophysiologist. Locations include three Electrophysiology Practice sites in the Greater Kansas City Area as well as one outreach site location and Electrophysiology services in four hospitals.

 

About Overland Park
Regional Medical Center

Overland Park Regional Medical Center is a licensed 343-bed facility offering acute medical care services to our patients. The hospital campus features four medical office buildings, two pharmacies, and the offices of more than 100 physicians. Cardiovascular programs at OPRMC have received certification from The American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). OPRMC’s clinicians and physicians experts excel in a wide range of interventional cardiology practices and complex electrophysiology procedures, including Complex Arrhythmia Management (Afib, VTACH, PVC, SVT), Convergent AFib Ablation (with C.T. surgeon and E.P.), Leadless Pacemakers & Internal Cardiac Defibrillators, and Left Atrial Appendage Closure.

 

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(T.M.) 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(T.M.) was engineered to address the limitations of existing E.P. technologies by empowering physicians with superior signals and actionable insights.

To date, over 75 physicians have completed over 2500 patient cases with the PURE EP(T.M.) System. The Company is in a national commercial launch of the PURE EP(T.M.) 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(T.M.) System in a multi-center study at centers of excellence including Texas Cardiac Arrhythmia Institute at St. David’s Medical Center  was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the 
Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(T.M.) signals over conventional sources.

 

Forward-looking
Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Source: BioSig Technologies, Inc.

Released July 7, 2022

Tonix Pharmaceuticals Announces Presentation at the World Orphan Drug Congress USA

CHATHAM, N.J., July 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it will present at the World Orphan Drug Congress USA 2022 being held July 11-13, 2022 at the Hynes Center in Boston, MA. The presentation will take place on Monday, July 11, 2022 at 2:00 p.m. ET.

Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals will deliver a presentation titled, “TNX-2900 (Intranasal Oxytocin + Magnesium) in Development for the Treatment of Hyperphagia in Adolescents and Young Adults with Prader-Willi Syndrome.”

Presentation Details
Date: Monday, July 11, 2022
Time: 2:00 p.m. ET
Conference website: World Orphan Drug Congress USA 2022

A copy of the Company’s presentation will be available under the Presentations tab of the Investors section of the Tonix website at www.tonixpharma.com following the conference.

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 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) 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

Wednesday, July 06, 2022

Ayala Pharmaceuticals (AYLA)
Interim Data From RINGSIDE Phase 2/3 Trial Indicate Efficacy

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Interim Analysis Of The Phase 2/3 RINGSIDE Trial Announced.  Ayala reported encouraging results from the interim analysis from Part A of the RINGSIDE trial testing AL102 in desmoid tumors.  The RINGSIDE trial is a two-part trial testing AL102, Ayala’s oral gamma secretase inhibitor.  Part A tests three dosing regimens to determine safety, tolerability, and change in  tumor volume by MRI scans.  These data will be used to select a dose for Part B, the double-blind placebo-controlled portion.

Interim Data Appears Favorable.  The announcement summarized the interim results, with full data to be presented at an upcoming medical meeting.  The company stated that AL102 demonstrated substantial anti-tumor activity, was well tolerated, and it reiterated plans to initiate Part B in 3Q22.  We expect the full results to meet efficacy expectations and provide the information needed to select the dose for Part B….

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.