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Release – Tonix Pharmaceuticals Enters into Agreement to Acquire Two FDA-Approved, Marketed Migraine Products from Upsher-Smith Laboratories, LLC

Posted on June 26, 2023June 26, 2023 by aweinsoff@channelchek.com

June 26, 2023 7:00am EDTDownload as PDF

Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) are Indicated for the Treatment of Acute Migraine in Adults

Strategic Acquisition Helps Build Tonix’s Commercial Capabilities and Infrastructure Ahead of Potential Launch of TNX-102 SL for the Treatment of Fibromyalgia

Acute Migraine Products Complement Tonix’s Current Intranasal Clinical Development Program of TNX-1900 for Migraine Prevention

Injection and Nasal Spray Products that Bypass the Gastrointestinal Tract Have the Potential to Provide Treatment Options for Migraine Associated with Nausea

CHATHAM, N.J., June 26, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix Pharmaceuticals or Tonix) and its wholly-owned subsidiary Tonix Medicines, Inc. (Tonix Medicines), a clinical-stage biopharmaceutical company, today announced that they have entered into an agreement to acquire two currently-marketed products from Upsher-Smith Laboratories, LLC (Upsher-Smith): Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are both indicated for the treatment of acute migraine with or without aura in adults. Zembrace SymTouch is the only branded sumatriptan autoinjector professionally promoted in the United States and is designed for ease of use and favorable tolerability with a low 3 mg dose.^1,3 Tosymra is a novel intranasal sumatriptan product formulated with a permeation enhancer that provides rapid and efficient absorption of sumatriptan.^4,5 Collectively, these products generated product sales of approximately $23 million for the full year 2022.⁶ Zembrace SymTouch and Tosymra each may provide onset of migraine pain relief in as few as 10 minutes for some patients and currently have patent protection to 2036 and 2031, respectively.^1,4

Under the terms of the agreement with Upsher-Smith:

Tonix Medicines will make an upfront payment of $12 million in cash to Upsher-Smith at closing and an additional $3 million in March 2024, or upon earlier conclusion of the transition services period.
In addition, Tonix Medicines will pay approximately $10 million in cash to Upsher-Smith at closing to acquire certain product-related inventories.
To support the transition of the products, Upsher-Smith has agreed to provide certain commercial operations, regulatory and other transition services to Tonix Medicines for up to nine months after closing, in exchange for agreed upon service fees.
The assets to be acquired include New Drug Applications issued by the U.S. Food & Drug Administration for the products, as well as patents and trademarks related to the products in the United States and in certain countries outside the United States.
The closing is expected to take place on June 30, 2023.

“Approximately 16% of Americans suffer from migraines, which represents about 40 million patients in the U.S.⁷,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Sumatriptan remains the acute migraine ‘gold standard’ treatment for many patients and continues to represent the largest segment of the market in terms of unit sales.⁸ With migraine pain relief possible in as few as ten minutes for some patients and convenient administration, we believe both Zembrace SymTouch and Tosymra are well-suited to address the unmet needs of patients using traditional or emerging oral acute migraine medications, particularly for rapid-onset treatment.”

“Despite increasing options for prevention and treatment of migraine, migraine headaches and breakthrough migraine headaches remain significant unmet needs, and can lead to emergency room visits,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “For adults needing acute treatment of migraine, Zembrace SymTouch and Tosymra have the potential to be first-line treatments or ‘rescue’ medications for breakthrough migraines, due to their fast onset of action and high pain-relief rates. For certain patients who present to ERs, Zembrace SymTouch and Tosymra also provide ER staff a straightforward acute treatment option. Additionally, because both of these products bypass the gastrointestinal tract, they have the potential to provide a treatment option for migraines complicated by severe nausea and vomiting.”

“These two products are a strategic fit for our company, and we look forward to working with Upsher-Smith to ensure a smooth product transition. To that end, this transaction includes established manufacturing and supplier relationships that allow for a seamless transition of manufacturing and supply chain responsibilities. The franchise today is supported by managed care contracts covering approximately 200 million lives. During the transition, we expect to secure our own contracts,” said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines.

Dr. Lederman concluded, “In addition to the potential growth that these two on-market products represent over time, the acquisition helps build Tonix’s commercial capabilities ahead of the potential launch of our TNX-102 SL product candidate for the treatment of fibromyalgia. In addition, these products align strongly with our TNX-1900 (intranasal potentiated oxytocin) product candidate, in clinical development for the prevention of chronic migraine. This is an important step in the evolution of Tonix into a fully integrated pharmaceutical company.”

Zembrace SymTouch (sumatriptan injection) 3 mg is the only actively promoted brand of sumatriptan autoinjector in the United States (other sumatriptan autoinjector products on the market are Imitrex® and generics to Imitrex®). It has a unique low dose and has demonstrated onset of migraine pain relief in as few as 10 minutes (17% of patients vs. 5% for placebo).⁹ Zembrace SymTouch also demonstrated migraine pain freedom for 46% of patients (vs 27% for placebo) at 2 hours in a single-attack, double-blind study (N=230).² Zembrace SymTouch currently has patent protection to 2036. Tosymra (sumatriptan nasal spray) 10 mg employs Intravail® permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan.^3,4 Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo).^4,9,10 Tosymra currently has patent protection to 2031.

About Migraine

Nearly 40 million people in the United States suffer from migraine⁶ and it has been recognized as the second leading cause of disability in the world.¹¹ Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).¹²

References:

Zembrace SymTouch [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: February 2021.
Landy, S. et al. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: a multicenter, randomized, double-blind, placebo-controlled study. J Headache Pain. 19, 69 (2018).
Brand-Schieber E, Munjal S, Kumar R, et al. Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients. Med Devices (Auckl). 2016;9:131-137.
Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: Feb 2021.
Maggio ET. Intravail®: highly effective intranasal delivery of peptide and protein drugs. Expert Opinion Drug Delivery. 2006;3(4):529-539.
IQVIA 2022 retail sales from the National Sales Perspectives (NSP) audit within the SMART database estimates Zembrace sales of ~$19.6 M and Tosymra sales of ~$3.5 M
Buse et al. Burden of Illness Among People with Migraine and ≥ 4 Monthly Headache Days While Using Acute and/or Preventive Prescription Medications for Migraine. Journal of Managed Care & Specialty Pharmacy. 2020;26(10):1334-1343.
Upsher-Smith Laboratories; Data on File; 2023
Mathew NT, et al. Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine. US Sumatriptan Research Group. Arch Neurol. 1992;49(12):1271-1276.
Wendt J, et al. A randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a 4-mg dose of subcutaneous sumatriptan for the treatment of acute migraine attacks in adults. Clinical Therapeutics. 2006;28(4):517-526.
GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17(11):954-976.
Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211.

Zembrace® SymTouch® (sumatriptan Injection): IMPORTANT SAFETY INFORMATION

Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

Zembrace is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace if you have:

history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace may cause serious side effects including:

changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before

The most common side effects of Zembrace include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information, ask your provider.

This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE

Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.

Tosymra® (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:

discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

Tosymra is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

Do not use Tosymra if you have:

history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
severe liver problems
hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any ingredient in Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Tosymra may cause serious side effects including:

changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before

The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.

This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE
Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.

Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age.

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 topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with topline results expected in the first quarter of 2024. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the first quarter of 2024. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

*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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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.

Investor Contact

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

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Zembrace, SymTouch and Tosymra are registered trademarks of Upsher-Smith Laboratories, LLC. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are the property of their respective owners.

MAIA Biotechnology (MAIA) – Phase 2 THIO-101 Trial Reaches Recruitment Milestone

Posted on June 21, 2023June 21, 2023 by cpereira@noblefcm.com

Wednesday, June 21, 2023

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Patient Enrollment Updated. MAIA Biotechnology announced that the THIO-101 trial has enrolled 29 patients (out of 57 total patients) in Part B of the trial. Enrollment has been increasing since the recent opening of 13 new clinical trial sites in Eastern Europe. This stage of the trial is evaluating the safety, tolerability, and dosing for the Part C efficacy stage. The trial is on schedule to announce data in 3Q/4Q23.

MAIA Continues To Make Clinical Progress. The THIO-101 trial is testing THIO, a nucleoside analogue targeted at the telomeres of cancer cells. When THIO is taken up by the reproducing DNA, it stops the replication and leads to cell death, then starts an inflammatory response in the tumor. Preclinical models have demonstrated efficacy in several tumor types.

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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.

Release – PDS Biotech to be Added to Russell 2000® and Russell 3000® Indexes Effective June 26, 2023

Posted on June 20, 2023June 20, 2023 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

FLORHAM PARK, N.J., June 20, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corp. (NASDAQ: PDSB), a clinical-stage company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced today its expected addition to the broad-market Russell 2000^® and the Russell 3000^® Indexes in accordance with the 2023 Russell indexes annual reconstitution. PDS Biotech’s anticipated inclusion in the Russell indexes will be effective after the U.S. market opens on Monday, June 26, 2023.

“The expected addition of PDS Biotech to the Russell indexes is the latest milestone during a year in which we have made considerable progress with our lead candidate, PDS0101, including the presentation of promising interim data from the VERSATILE-002 Phase 2 clinical trial at ASCO 2023, and expanded our product portfolio and clinical pipeline with the acquisition of PDS0301,” stated Dr. Frank Bedu-Addo, President and CEO of PDS Biotech. “The Russell indexes are widely used investment benchmarks for index funds and active portfolio strategies. Our inclusion is an important validation and should help our efforts to propel long-term shareholder value, expand awareness of PDS Biotech within the investment community, increase the liquidity of our stock, and broaden our shareholder base.”

The annual reconstitution of the Russell indexes is conducted by FTSE Russell, a leading global index provider, and captures the 4,000 largest U.S. equities as of April 28, 2023, objectively ranking them by total market capitalization and style attributes. Membership in the U.S. all-cap Russell 3000 Index remains in place for one year and means automatic inclusion in the appropriate growth and value style indexes. Inclusion in the Russell 3000 Index also means automatic inclusion in either the large-cap Russell 1000^® Index or the small-cap Russell 2000 Index. Approximately $10.6 trillion in assets are benchmarked against Russell’s U.S. indexes.

About FTSE Russell
FTSE Russell is a global index leader that provides innovative benchmarking, analytics, and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $20.1 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers, and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products, and index-based derivatives. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.com.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^®, Versamune^® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune^® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA^® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political, and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613 
Email: drandolph@pdsbiotech.com   

Rich Cockrell 
CG Capital 
Phone: +1 (404) 736-3838 
Email: pdsb@cg.capital 

Media Contacts: 
Dave Schemelia 
Tiberend Strategic Advisors, Inc.
Phone: +1 (609) 468-9325 
Email: dschemelia@tiberend.com 

Bill Borden 
Tiberend Strategic Advisors, Inc. 
Phone: +1 (732) 910-1620 
Email: bborden@tiberend.com

PDS Biotechnology Corp. (PDSB) – Answering Questions About The VERSATILE-002 Data

Posted on June 16, 2023June 16, 2023 by cpereira@noblefcm.com

Friday, June 16, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

The Phase 2 VERSATILE-002 Trial Remains Misunderstood. We have received inquiries from investors about the data in the recent ASCO presentation by PDS Biotech. We believe there is some misunderstanding of the trial design, outcome data, and the trial’s definition of efficacy. In view of the fundamental progress and stock price decline, we believe this is a buying opportunity.

Trial Data Has Led To Misinterpretation. The Phase 2 VERSATILE-002 trial has a primary endpoint of best overall response rate (ORR). To be considered a responder, patients need to have tumor shrinkage of at least 30% in two MRI scans. Patients with one positive scan are considered unconfirmed responses until they have a second confirming scan at least 9 weeks later. Both confirmed and unconfirmed responses were reported at the recent ASCO conference.

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

Release – Tonix Pharmaceuticals Announces Publication of Results from Phase 3 RELIEF Trial of TNX-102 SL for the Management of Fibromyalgia

Posted on June 15, 2023June 15, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 15, 2023 7:00am EDT

Previously Disclosed Data Demonstrated that TNX-102 SL Achieved Statistically Significant Pain Reduction Over Placebo at Week 14 (Primary Endpoint, p=0.01) and Was Generally Safe and Well Tolerated

Topline Data from RESILIENT, a Potentially Confirmatory Registration-Enabling Phase 3 Fibromyalgia Trial of TNX-102 SL, Expected Fourth Quarter 2023

CHATHAM, N.J., June 15, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that previously disclosed results from the Phase 3 RELIEF study of TNX-102 SL for the management of fibromyalgia have been published in the peer-reviewed journal Arthritis Care & Research, an official journal of the American College of Rheumatology. In RELIEF, treatment with TNX-102 SL was associated with significant reductions in daily pain and was generally safe and well tolerated in patients with fibromyalgia. Secondary results also suggest that treatment with TNX-102 SL can improve sleep and reduce fatigue, which together with pain are recognized as core fibromyalgia symptoms. TNX-102 SL is a novel, non-opioid, centrally-acting analgesic, intended to be taken once daily at bedtime. The paper can be accessed online at https://pubmed.ncbi.nlm.nih.gov/37165930/.

“There continues to be a pressing need for novel, safe and more tolerable drugs to treat patients with fibromyalgia, a debilitating chronic disease that afflicts an estimated 6 to 12 million adults in the United States, with symptoms including multisite pain and disturbed sleep,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Current fibromyalgia therapies have limited efficacy in alleviating symptoms of sleep disturbance and fatigue. These Phase 3 RELIEF data suggest that treatment with TNX-102 SL may improve sleep quality and fatigue in patients with fibromyalgia, in addition to reducing pain.”

The paper, titled, “Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results From the Randomized, Placebo Controlled RELIEF Trial,” includes data demonstrating that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. Also, in an exploratory analysis, when the primary endpoint was analyzed as a ≥30% pain responder analysis, there was a higher rate of responders to TNX-102 SL (47%) than to placebo (35%; p=0.006). TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints demonstrating improvements in sleep quality, mitigation of fatigue and fibromyalgia-specific global symptomatic and functional recovery.

Early discontinuation rates were similar for TNX-102 SL and placebo (17.7% and 16.5%, respectively). In addition, TNX-102 SL was well tolerated with the most common adverse event from active treatment being oral numbness or hypoaesthesia, an administration site reaction that is typically transient, was never rated as severe, and lead to only one discontinuation.

Tonix is currently enrolling in a potentially confirmatory, registration-enabling Phase 3 study (RESILIENT). Topline results are expected in the fourth quarter of this year.

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

About the Phase 3 RESILIENT Study

The RESILIENT study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in the management of fibromyalgia. The two-arm trial is expected to enroll approximately 470 participants in the U.S. The first two weeks of treatment consist of a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint is the daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.

For more information, see ClinicalTrials.gov Identifier: NCT05273749.

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 topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the first quarter of 2024. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

^*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

Contacts

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

Maddie Stabinski (media)
Russo Partners
madeline.stabinski@russopartnersllc.com
(212) 845-4273

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

Source: Tonix Pharmaceuticals Holding Corp.

Released June 15, 2023

PDS Biotechnology Corp. (PDSB) – Reiterating Outperform – Phase 2 Trial Meets Efficacy Endpoint

Posted on June 15, 2023June 15, 2023 by cpereira@noblefcm.com

Thursday, June 15, 2023

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

ASCO Efficacy Data Has Been Updated. PDS Bioscience announced that the Phase 2 VERSATILE-002 trial has met the threshold for efficacy. This is good news for the trial and should help clarify misunderstandings of the data presented at the ASCO conference earlier this month. The Phase 3 trial is expected to begin in 3Q23.

New Data Should Clarify Trial Results. In our June Research Note, we discussed data from the VERSATILE-002 trial presented at the ASCO annual meeting. This presentation showed a 12-month survival rate of 87% and a progression-free survival rate of 10.4 months. Responses were determined by the RECIST 1.1 criteria, requiring 30% tumor shrinkage. According to the trial protocols, responses seen in the first scan were considered unconfirmed responses until a second confirmatory scan 9 weeks later.

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

Onconova Therapeutics (ONTX) – New Leukemia Data Presented Supports Wide Range Of Action

Posted on June 15, 2023June 15, 2023 by cpereira@noblefcm.com

Thursday, June 15, 2023

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China. Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Data In Mantle Cell Lymphoma Updated. Onconova presented new data testing narazaciclib in mantle cell lymphoma (MCL) at the annual International Conference on Malignant Lymphoma, adding to data presented at the AACR meeting in April 2023. The preclinical studies tested the combination of narazaciclib as a single agent or in combination with ibrutinib (Imbruvica from AbbVie, an inhibitor of BTK or Bruton tyrosine kinase), a drug widely used to treat mantle cell lymphoma. Narazaciclib also was tested against approved CDK4/6 inhibitors and showed superior efficacy.

Presentation Expands On Previous Data. Narazaciclib was tested with ibrutinib in multiple cell lines that are sensitive or resistant to ibrutinib. The combination showed anti-tumor activity that was synergistic compared with either drug alone. The drugs were shown to use separate pathways to downregulate cell cycle checkpoints and lead to G1 cell cycle arrest. This stops the cancer cells reproduction cycle, causing the cell to die. The combination inhibited tumor growth and reduced infiltrations of malignant B-cells in the bone marrow.

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

Release – PDS Biotechnology Announces Achievement of Efficacy Threshold in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 and KEYTRUDA® in Head and Neck Cancer

Posted on June 14, 2023June 14, 2023 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

14 patients in the immune checkpoint inhibitor naïve arm of VERSATILE-002 have experienced either a complete response or partial response on two consecutive scans, thus constituting a confirmed objective response
Efficacy and safety continue to be monitored as additional patients have yet to undergo imaging evaluation

FLORHAM PARK, N.J., June 14, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced today the Company achieved the threshold for efficacy as per investigator assessment in Stage 2 of the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer. The achievement of full recruitment of 54 patients in the ICI naïve arm was announced in May 2023. The threshold for efficacy, as defined in the clinical protocol, was achieved when 14 out of the 54 immune checkpoint inhibitor (ICI) naïve patients enrolled achieved a confirmed objective response. Additional patients in the trial have yet to undergo imaging evaluation.

Per RECIST 1.1, the standard to classify oncologic imaging outcomes in clinical trials, patients are considered to have achieved an objective response when imaging studies document tumor shrinkage of 30% or more. In VERSATILE-002, the primary endpoint requires two consecutive scans 9 to 12 weeks apart, rather than one, to be considered a confirmed objective response. Confirmation with two consecutive scans is not required to achieve an objective response in every clinical trial per RECIST 1.1.

At the recent 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, we presented data showing 9 confirmed responses among 34 evaluable patients. Median progression-free survival (PFS) of 10.4 months was also presented at the 2023 ASCO Annual Meeting along with a 12-month overall survival (OS) rate of 87.1% for patients with a CPS≥1. Additional patients have been assessed since data was presented at the 2023 ASCO Annual Meeting. With these additional data, a total of 14 patients have now achieved a confirmed response to date. The achievement of this endpoint suggests an additive effect of PDS0101 over published results with ICI monotherapy and is based on statistical calculations using the appropriate power and alpha.

The primary endpoint in the VERSATILE-002 study is the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1. The key secondary endpoints are progression-free survival (PFS), OS at 12 and 24 months, safety, and tolerability. The study utilizes a Simon’s 2-stage optimum design.

“We are highly encouraged by the growing set of PDS0101 efficacy and safety data being generated in multiple independent trials by leading experts in the field,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “The consistency in PDS0101 induced HPV16-specific immune responses, the response rates and survival benefit observed in multiple types of HPV cancer and at different stages of disease, aligns with both the preclinical and Phase 1 monotherapy results. Multiple studies have demonstrated the induction of high levels of active and potent, HPV16-specific CD4 and CD8 T cells, as well as long-lasting memory CD8 T cells by PDS0101.”

“Achieving the efficacy threshold in VERSATILE-002 is an important milestone for the Company, especially as it has been achieved ahead of the full efficacy evaluation for this cohort,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “With our Phase 2 trial near completion, and our planned global Phase 3 confirmatory randomized, controlled trial, VERSATILE-003, actively advancing, we believe we are closer to our goal of providing a well-tolerated, safe and effective therapy for those who suffer from head and neck cancer, a critical unmet medical need.”

PDS Biotech plans to initiate the VERSATILE-003 as a result of the successful completion of an End-of-Phase 2 meeting in the third quarter of 2022 with the FDA, during which PDS Biotech received guidance on key elements of the Phase 3 program that will support the submission of a Biologics License Application (BLA). The planned primary endpoints for VERSATILE-003 are OS and PFS. In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the FDA in the third quarter of 2023.

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002

VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

Interim efficacy and safety data were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting for ICI-naïve patients (PR link). Preliminary data from the first 34 patients demonstrated a 12-month overall survival rate of 87% and median progression free survival of 10.4 months. No Grade 4 or higher treatment related adverse events were observed.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.

About VERSATILE-003

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy. The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

About Versamune®
Versamune® is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune® based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune® based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune® based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  
Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
dschemelia@tiberend.com

Bill Borden
Phone: +1 (732) 910-1620
bborden@tiberend.com

Release – Onconova Therapeutics Presents Preclinical Data On Narazaciclib At The 17th International Conference On Malignant Lymphoma

Posted on June 14, 2023June 14, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ONTX

Jun 14, 2023

Narazaciclib demonstrated significant synergistic anti-cancer activity in multiple in vivo models of mantle cell lymphoma (MCL) when combined with ibrutinib, the current standard-of-care

NEWTOWN, Pa., June 14, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today presented preclinical data on narazaciclib at the 17^th International Conference on Malignant Lymphoma (ICML), which is taking place in Lugano, Switzerland, through June 17, 2023.

Data from the Josep Carreras Leukaemia Research Institute expanded on a prior presentation at the recent American Association for Cancer Research (AACR) Annual Meeting, showing that narazaciclib’s antitumor activity against mantle cell lymphoma (MCL) cell lines was superior to that of the FDA-approved CDK 4/6 inhibitors palbociclib and ribociclib, and similar to that of the FDA-approved CDK 4/6 inhibitor abemaciclib. Combining narazaciclib with the FDA-approved Bruton’s tyrosine kinase inhibitor ibrutinib led to synergistic increases in antitumor activity against both ibrutinib-sensitive and ibrutinib-resistant MCL cell lines. In addition, treatment with narazaciclib combined with ibrutinib led to significant inhibition of tumor growth and significant reductions in malignant B cell infiltration into the bone marrow in multiple chicken embryo chorioallantoic membrane xenograft models of MCL.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “The data being presented at ICML provide further evidence of narazaciclib’s potential to combine synergistically with a wide range of therapeutic classes, derived from its ability to inhibit CDK 4, 6, and additional kinases involved in cancer cell survival and metastasis. This differentiated kinase inhibitory profile also confers expansive therapeutic potential across a variety of indications and may enable narazaciclib to overcome the efficacy limitations and safety concerns of currently marketed CDK 4/6 inhibitors. Given ibrutinib is the standard-of-care in mantle cell lymphoma, the preclinical results showing narazaciclib improving antitumor responses in combination represents a promising development that speaks to its potential therapeutic utility in this high unmet need indication. We look forward to discussing our data throughout ICML as we continue to evaluate additional opportunities for clinical studies with narazaciclib and advance our ongoing Phase 1/2a combination trial of narazaciclib plus estrogen blockade in endometrial cancer.”

The ICML poster, titled, “Prolonged cell cycle arrest by the CDK 4/6 antagonist narazaciclib restores ibrutinib response in preclinical models of BTKi-resistant mantle cell lymphoma,” is currently available to registered attendees of ICML via the conference’s e-poster gallery. The poster will also be displayed during the in-person poster sessions being held throughout the conference. A copy of the poster will be available on the “Scientific Presentations” section of the Onconova website following the conclusion of the conference.

About Onconova Therapeutics, Inc.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

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

Forward Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

MustGrow Biologics Corp. (MGROF) – Growing Production

Posted on June 14, 2023June 14, 2023 by cpereira@noblefcm.com

Wednesday, June 14, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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.

Completed Run. Yesterday, MustGrow filed a press release stating the Company successfully completed its initial commercial run-rate production of its mustard plant-based biocontrol liquid via a contract manufacturer. The run-rate of the production reached greater than 5,000 litres per day of the biocontrol liquid.

Revenue Translation. The production of the mustard plant-based biocontrol liquid technology is estimated to equal approximately USD$25 million of annual revenue at a retail level, along with creating zero residual waste through generating a high protein ingredient for animal feed. Based on the trial run, we believe the estimated annual production of the liquid would cover a fraction of the demand, and we estimate the trial run annual production liquid would cover some 25,000-50,000 acres.

Get the Full Report

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

Release – ZyVersa Therapeutics Publishes New White Paper Detailing the Critical Role of Inflammasome ASC in Inflammatory Diseases, and Its Potential as a Therapeutic Target

Posted on June 13, 2023June 13, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jun 13, 2023

PDF Version

White paper summarizes the research of leading inflammasome experts, Drs. Helen Bramlett, Juan Pablo de Rivero Vaccari, W. Dalton Dietrich, and Robert W. Keane, University of Miami Miller School of Medicine
ASC, in monomeric form or as ASC specks, is central to initiation, amplification, and perpetuation of damaging inflammation leading to progressive tissue injury and chronic inflammatory diseases
The World Health Organization reports that chronic inflammatory diseases (heart disease, cancer, chronic respiratory disease, and diabetes) significantly threaten human health (led to death in over 33 million people worldwide in 2019)

WESTON, Fla., June 13, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with inflammatory and renal diseases who have significant unmet medical needs, announces availability of a new white paper on the critical role of inflammasome ASC in the development and progression of a wide-range of inflammatory diseases. Data suggest that drugs targeting ASC may provide the best opportunity to control damaging inflammation associated with diseases affecting millions of people worldwide. The white paper titled, “Inflammasome ASC: A Promising Therapeutic Target,” can be accessed by Clicking Here.

The white paper highlights groundbreaking research from the labs of Drs. Bramlett, de Rivero Vaccari, Dietrich, and Keane, pioneers in the field of inflammasomes and members of ZyVersa’s Scientific Advisory Board. To read their biographies, Click Here.

“After 15 years of research to develop an understanding of how inflammasomes contribute to so many diverse diseases and conditions, we discovered the critical role of the ASC component and developed a monoclonal antibody, known as Inflammasome ASC Inhibitor IC 100,” stated Dr. Keane. “ASC is central to formation and activation of multiple inflammasome complexes associated with numerous diseases. ASC forms a large filamentous structure, the ASC speck, which is released from cells, amplifying and perpetuating inflammation. We believe that targeting ASC provides the best opportunity to control damaging inflammation.”

Dr. de Rivero Vaccari added, “We have studied IC 100 in animal models of diverse diseases and injuries including multiple sclerosis, age-related inflammation associated with neurodegenerative diseases, Alzheimer’s disease, acute respiratory distress syndrome, traumatic brain injury, and spinal cord injury. Each of these conditions demonstrated that IC 100 inhibited inflammasome activation, which resulted in improved histopathology and/or improved functional outcomes. We are continuing our research in other diseases, including Parkinson’s disease, for which we were awarded a grant from the Michael J. Fox Foundation.”

“ZyVersa, which obtained a worldwide license for Inflammasome ASC Inhibitor IC 100, is honored to collaborate with Drs. Bramlett, de Rivero Vaccari, Dietrich, and Keane to advance development of IC 100 into human trials,” said Stephen C. Glover, Co-founder, Chairman, CEO, and President of ZyVersa. “We have progressed manufacturing of IC 100 through GMP production, and our IND-enabling preclinical program has progressed through demonstration of IC 100 safety in dose-ranging toxicology studies in mice and monkeys.”

Mr. Glover continued, “We expect to complete the preclinical program for IC 100 by year’s end, and file an IND to initiate a Phase 1 trial in early 2024. We are excited about our progress, as we believe Inflammasome ASC Inhibitor IC 100 has potential to transform treatment of debilitating inflammatory diseases.”

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 attenuates both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:

Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Release – MustGrow Completes Initial Commercial Production Run via Contract Manufacturer

Posted on June 13, 2023June 13, 2023 by aweinsoff@channelchek.com

Succesful completion of initial commercial run-rate production via third-party contract manufacturer.
Production run-rate of the extract reached greater than the equivalent of 5,000 litres per day of MustGrow’s mustard plant-based biocontrol liquid technology.
Estimated equivalent annual capacity equates to approximately US$25 million in grower level revenue without the need to construct capital intensive production facilities.

SASKATOON, Saskatchewan, Canada, Jun. 13, 2023 – MustGrow Biologics Corp. (TSXV: MGRO) (OTC: MGROF) (FRA: 0C0) (the “Company” or “MustGrow”), is pleased to announce the successful initial commercial run-rate production of its mustard plant-based biocontrol liquid via a contract manufacturer.

MustGrow believes this production milestone further validates the Company’s commercialization strategy to initially utilize a third party contract manufacturer rather than construct its own capital-intensive pilot and/or commercial production facilities. The continuous production run-rate of the extract reached greater than the equivalent of 5,000 litres per day of MustGrow’s mustard plant-based biocontrol liquid technology, which is estimated to equal approximately US$25 million in annual grower level revenue. The production process created zero residual waste by generating a high protein byproduct ingredient for animal feed.

MustGrow’s CEO, Corey Giasson noted: “This is a key transition for MustGrow, now able to complete our first commercial-level production without needing to build our own capital-intensive facility. We are now confident that we will be capable of producing commercially-scalable quantities of TerraSante^TM and TerraMG^TM in preparation for initial registration approvals. The continuous-flow design process ran without any reported upsets and we are close to maximum theoretical recovery of our targeted mustard extracts in the concentrate. This milestone successfully demonstrates a low-risk continuous-flow process, while further mitigating commercialization risk.”

Utilizing a third party contract manufacturer markedly derisks commercial capabilities in MustGrow’s soil amendment and biofertility technologies, as well as biocontrol and postharvest food preservation, which are currently under development with four global partners: Janssen PMP, Bayer, Sumitomo Corporation, and NexusBioAg.

———

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility. MustGrow has approximately 49.7 million basic common shares issued and outstanding and 55.6 million shares fully diluted. For further details, please visit www.mustgrow.ca.

ON BEHALF OF THE BOARD

“Corey Giasson”

Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: (i) estimated grower level revenue; (ii) the ability of the Company to produce commercially-scalable quantities of TerraSante^TM and TerraMG^TM; (iii) risk levels associated with the continuous flow process; (iv) the continued success of its commercialization strategey including the commercial run-rate production of its mustard plant-based biocontrol liquid via a contract manufacturer; and (v) the maximum theoretical recovery of targeted mustard extracts in the concentrate.

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) the preferences and choices of agricultural regulators with respect to product approval timelines; (ii) the ability of MustGrow’s partners to meet obligations under their respective agreements; and (iii) other risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

Release – Ocugen, Inc. Announces Adjournment Of Annual Meeting Of Shareholders

Posted on June 12, 2023June 12, 2023 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

June 9, 2023

MALVERN, Pa., June 09, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Company’s 2023 Annual Meeting of Shareholders (Annual Meeting) was convened and adjourned, without any business being conducted, due to lack of the required quorum.

A quorum consists of the presence at the Annual Meeting either online during the live audio webcast or represented by proxy of the holders of a majority of the voting power of our outstanding shares of common stock entitled to vote at the Annual Meeting. There were fewer than a majority of shares entitled to vote present, either in person or by proxy at the Annual Meeting. The Annual Meeting therefore had no quorum, and accordingly, the Annual Meeting has been adjourned. The Annual Meeting will resume with respect to all proposals at 11 a.m. Eastern Time on Friday, June 23, 2023 and will continue to be held virtually.

The record date for determining shareholders eligible to vote at the Annual Meeting will remain the close of business on April 13, 2023. Shareholders who have already submitted a proxy do not need to vote again for the reconvened Annual Meeting, as the proxies submitted will remain valid. Shareholders who have already submitted proxies and would like to change their vote with respect to any of the proposals can update their vote in the manner set forth in the Definitive Proxy Statement. Your vote will be recorded at the Annual Meeting in accordance with your most recently submitted proxy.

Ocugen shareholders as of close of business on the April 13, 2023 record date who have not yet voted are encouraged to vote online at www.proxyvote.com or by telephone at 1-800-690-6903. Shareholders that need assistance voting or have questions, may contact Ocugen’s proxy solicitation firm, Innisfree M&A Incorporated, at (877) 750-8198.

Voting on all proposals will be open until the conclusion of Ocugen’s 2023 Annual Meeting on June 23, 2023.

If you hold your shares of our common stock with a broker, bank, or other holder of record as nominee or agent, you may be subject to an earlier voting deadline and you should carefully review any materials received from the nominee or agent regarding how to vote your shares.

A copy of the Definitive Proxy Statement is available to shareholders on the Company’s website and at the website maintained by the SEC at www.sec.gov.

Ocugen shareholders as of the April 13, 2023 record date for the Annual Meeting are invited to attend the virtual Annual Meeting by visiting www.virtualshareholdermeeting.com/OCGN2023.

Important Information

This material may be deemed to be solicitation material in respect of the Annual Meeting to be reconvened and held on June 23, 2023. In connection with the Annual Meeting, the Company filed a Definitive Proxy Statement with the SEC on April 20, 2023. BEFORE MAKING ANY VOTING DECISIONS, SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE ANNUAL MEETING. The Definitive Proxy Statement was mailed to shareholders who are entitled to vote at the Annual Meeting. No changes have been made to the proposals to be voted on by shareholders at the Annual Meeting. The Company’s Definitive Proxy Statement and any other materials filed by the Company with the SEC can be obtained free of charge at the SEC’s website at www.sec.gov or the Company’s website www.ocugen.com.

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

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:
Tiffany Hamilton
Head of Corporate Communications
IR@ocugen.com