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• The authors conclude that “nasal anti-CD3 has the potential to be a non-toxic novel immunotherapeutic approach for the treatment of
  Alzheimer’s disease (AD)”
• FDA has cleared the IND for intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for human study in mild to moderate Alzheimer’s Disease
• The publication shows anti-CD3 monoclonal antibody (mAb) administered intranasally, ameliorates disease in a 3xTg model of Alzheimer’s disease by targeting microglial activation in the brain, while expanding regulatory T cells in the periphery
• Remarkably, this reduced microglial activation and improved cognition occurs independent of amyloid beta disposition.

NEW YORK, Sept. 06, 2023 (GLOBE NEWSWIRE) — Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced acceptance of a publication, “Nasal Administration of anti-CD3 monoclonal antibody (mAb) ameliorates disease in a mouse model of Alzheimer’s disease”, in the preeminent¹ journal, Proceedings of the National Academy of Sciences (PNAS), that supports foralumab’s mechanism as a potential treatment for Alzheimer’s disease (AD), a difficult-to-treat neuroinflammatory disease.²   This is the second publication pertaining to intranasal administration of anti-CD3 monoclonal antibody this year to be published in PNAS.³

This study shows that intranasal anti-CD3 ameliorates disease in a rodent model of AD by targeting microglial activation in the brain and brain gene expression independent of affecting amyloid beta deposition. These studies identify a novel approach to treat Alzheimer’s disease.

The publication can be found at : https://www.pnas.org/doi/10.1073/pnas.2309221120

Howard L. Weiner, M.D., a Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System and Chairman of Tiziana’s Scientific Advisory Board, stated, “I am proud to be the senior author on this seminal publication showing that anti-CD3 mAb mitigates Alzheimer’s disease in a rodent model. Remarkably, we found this benefit occurred independent of reduction of amyloid beta plaque in the brain. This finding demonstrates a unique mechanism of action that can now be tested in humans using foralumab, a fully human anti-CD3 mAb, foralumab, in which we modulate microglia by inducing T cells in the periphery that migrate to the brain. This represents a unique approach to treating Alzheimer’s disease that could also potentially be employed in combination with anti-amyloid therapy. The neuromodulation of the T cell inflammatory response we observed in the brains of Alzheimer’s mice is consistent with multiple sclerosis research we have conducted at the Ann Romney Center and validates our scientific rationale for testing foralumab in Alzheimer’s patients after the recent IND clearance by the United States Food and Drug Administration.”

“We’ve now have had two seminal publications in the esteemed journal PNAS related to novel and significant research on intranasal anti-CD3. It has been established through both publications that intranasal anti-CD3 positively modulates the immune system allowing Tiziana to explore foralumab in multiple neuro-inflammatory disease indications in addition to our ongoing research in non-active secondary progressive multiple sclerosis. We believe this scientific publication, along with the groundbreaking research continuously being conducted by our partners at Brigham and Women’s Hospital led by Dr. Weiner, greatly increases the utilization potential of our foralumab portfolio,” commented Gabriele Cerrone, Executive Chairman, founder and acting Chief Executive Officer of Tiziana.

Study Rationale

Alzheimer’s disease is a neurodegenerative disease characterized by amyloid beta (Aβ) plaques, neurofibrillary tangles, and microglial activation. Neuroinflammation is a major component of AD. Microglia are the primary immune cells of the brain that help both maintain homeostasis and react to injury. Studies showing activated microglia and astrocytes surrounding Aβ plaques suggest significant involvement of inflammatory pathways in Alzheimer’s disease. Therapies targeting Aβ have shown positive effects in subjects with AD. Nasal anti-CD3 has been shown to treat animals with a progressive form of experimental autoimmune encephalomyelitis (EAE), a model for multiple sclerosis, by inducing regulatory T cells that dampen microglial inflammation in the brain.

Study Design

In this study, mice were treated three times a week with intranasal anti-CD3 for five months and compared against isotype control or saline. In the treated mice, the study found modulation of the activated microglia phenotype, changes in gene expression patterns in the brain and improved cognition, which all occurred independent of affecting amyloid beta deposition. Modulation of activated microglia was measured in treated mice by sorting the microglia using microglia-specific markers and performing a gene expression analysis using the Nanostring mouse myeloid panel and comparing treated mice versus control. Changes in gene expression were measured in the cortex and hippocampus. Cognition was measured including spatial learning and long- and short- term memories as assessed by the Morris water maze and the novel arm Y-maze behavioral test. Amyloid beta accumulation was measured by immunofluorescence in the hippocampus and prefrontal cortex areas of the brain.

About Foralumab

Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets, an effect demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. Intranasal foralumab Phase 2 trials are expected to start in Q3 2023 in patients with non-active SPMS immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases that affects the brain and other organs.^2,3

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For further inquiries:

Tiziana Life Sciences Ltd

Paul Spencer, Business Development and Investor Relations
+44 (0) 207 495 2379
[email protected]

Investors:

Irina Koffler
LifeSci Advisors, LLC
646.970.4681
[email protected]

---

¹
https://www.pnas.org/about/article-journal-metrics

²
https://www.pnas.org/doi/10.1073/pnas.2309221120

³
https://www.pnas.org/doi/10.1073/pnas.2220272120

 

LOS ANGELES, Sept. 06, 2023 (GLOBE NEWSWIRE) — ACELYRIN, INC. (Nasdaq: SLRN), a late-stage biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that Founder and Chief Executive Officer Shao-Lee Lin, MD, PhD will participate in a moderated fireside chat during the Morgan Stanley 21^st Annual Global Healthcare Conference being held September 11-13, 2023 in New York.

Event: Morgan Stanley 21

^st

Annual Global Healthcare Conference

Date: Wednesday, September 13^th
Time: 11:30 am ET

A live webcast of Dr. Lin’s fireside chat will be available via the “Events” section of the Company’s website at www.acelyrin.com. A replay of the webcast will be archived on the website for 30 days.

About ACELYRIN

ACELYRIN, INC. (Nasdaq: SLRN) is a Los Angeles area-based late-stage clinical biopharma company – with additional operations in the San Francisco Bay area – focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines.

Forward Looking Statements

Some statements in this press release are, or may be considered, forward-looking statements, including statements regarding ACELYRIN’s business plans, including our plans to initiate additional clinical trials, as well as the potential future benefits of our product candidates. While ACELYRIN, INC. considers any projections to be based on reasonable assumptions, these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated in such forward-looking statements.

CONTACTS

:

ACELYRIN, INC.

Tyler Marciniak
Vice President of Investor Relations,
Communications and Corporate Operations
[email protected]
[email protected]

Tosymra Nasal Spray 10 mg is a Proprietary Acute Migraine Treatment Approved Under the 505(b)2 Pathway Based on Bioequivalence to Imitrex (sumatriptan) Injection 4 mg

GlaxoSmithKline Recently Notified FDA that it will Discontinue Imitrex Nasal Spray 5 mg and 20 mg Products after January 2024

CHATHAM, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it is committed to meeting potential increased demand for Tosymra® (sumatriptan) nasal spray 10 mg after GlaxoSmithKline’s (GSK) planned discontinuation of Imitrex (sumatriptan) nasal spray 5 mg and 20 mg products after January, 2024.

On August 8, 2023, GSK informed the U.S. Food and Drug Administration (FDA) of its plan to discontinue Imitrex nasal spray 5 mg and 20 mg doses after January 31, 2024. The notification is posted on the FDA Drug Shortages website.¹ Tonix is preparing for potential increased demand for Tosymra (sumatriptan nasal spray) 10 mg to help avoid possible drug shortages for patients who suffer from migraines. Tosymra nasal spray is approved on the basis of bioequivalence to Imitrex injection 4 mg.

Drug shortages have presented an ongoing challenge for the U.S. healthcare system, reaching near-record levels² in recent months, causing treatment delays and rationing. Tonix is ready to step in to alleviate potential shortages in sumatriptan, a widely used treatment option for acute migraine.

“In response to FDA outreach, we have confirmed our commitment to meet potential increased demand for sumatriptan nasal spray from patients who suffer from migraines,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “While Tosymra nasal spray and Imitrex nasal spray are not substitutable at the pharmacy, we plan to alert providers to the possibility of prescribing Tosymra for patients who may benefit from a nasal spray formulation of sumatriptan.”

The American Headache Society Consensus Statement on migraine treatments recommends that “a non-oral formulation should be used in patients whose attacks are associated with severe nausea or vomiting, who do not respond well to traditional oral treatments, or who have trouble swallowing orally administered medications.”³ Approximately 73% of migraine patients have been reported to experience nausea with or without vomiting during their attacks.⁴

“Intranasal sumatriptan is an important therapy for those who suffer from migraines. We believe Tosymra is differentiated from other intranasal formulations of sumatriptan, which are generic equivalents to Imitrex nasal spray because of its proprietary Intravail® absorption enhancer technology,” said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines. “Intravail technology helps the medication absorb into the bloodstream so it can work quickly, providing migraine pain relief in as little as 10 minutes for some patients.”^5,6,7

About Migraine

Nearly 40 million people in the United States suffer from migraine⁸ and it has been recognized as the second leading cause of disability in the world.⁹ 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).

Tonix Pharmaceuticals Holding Corp.

^*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 development 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 development 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 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

¹FDA Drug Shortage, accessed Aug 24, 2023 – https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sumatriptan+Nasal+Spray&st=d&tab=tabs-2
²CNN, accessed September 1, 2023 – https://www.cnn.com/2023/08/10/health/drug-shortage-pharmacist-survey/index.html
³Ailani J, et al. Headache. 2021. 61: 1021–1039
⁴Newman LC. Headache. 2013. 53 Suppl 1:11-6
⁵Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: 2021
⁶Mathew NT, et al. Arch Neurol. 1992. 49(12):1271-6
⁷Wendt J, et al. Clinical Therapeutics. 2006. 28(4):517-526
⁸Burch RC, et al. Neurol Clin. 2019. 37(4):631-649
⁹Steiner TJ, et al. J Headache Pain. 2020. 21(1): 137

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

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; risks related to the failure to successfully market any of our products; 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
[email protected]
(862) 904-8182

Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
[email protected]
(919) 360-3039

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.

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.

NEW YORK and SAN DIEGO, Sept. 06, 2023 (GLOBE NEWSWIRE) — Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis, will participate in a fireside chat at the Morgan Stanley 21^st Annual Global Healthcare Conference on Wednesday, September 13, 2023 at 10:10 a.m. ET, held in New York City.

Access to a live webcast of this event, as well as an archived recording, will be available under the “Events & Presentations” tab on the Investors & Media section of the Company’s website at https://ir.zentalis.com/news-events/events-presentations.

About Zentalis Pharmaceuticals

Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. Utilizing its Integrated Discovery Engine, the Company is developing a focused pipeline of potentially best-in-class oncology candidates, which include azenosertib (ZN-c3), a WEE1 inhibitor for advanced solid tumors, ZN-d5, a BCL-2 inhibitor for hematologic malignancies and related disorders, and a heterobifunctional degrader of BCL-xL for solid and hematological malignancies. The Company is also leveraging its extensive experience and capabilities across cancer biology and medicinal chemistry to advance its research on protein degraders. Zentalis has operations in both New York and San Diego.

For more information, please visit www.zentalis.com. Follow Zentalis on Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.

Contact:

Katie Beach Oltsik
Evoke Canale
[email protected]

• Robust Customer Activity in, Wi-Fi CPE, 5G Mobile, 5G Infrastructure, Automotive, Timing Control, Semiconductor Back-End-Services, and Other Markets
• Introduced Advanced Single Crystal XBAW
  
  ^®
  
  Technology for Existing and New Markets
• Launched State-of-the-Art XBAW
  
  ^®
  
  Foundry Services and AI-Enabled Engineering Design Software
• Company to Host Investor Update Call Today at 8:00 am ET

Charlotte, N.C., Sept. 06, 2023 (GLOBE NEWSWIRE) — Akoustis Technologies, Inc. (NASDAQ: AKTS) (“Akoustis” or the “Company”), an integrated device manufacturer (IDM) of patented bulk acoustic wave (BAW) high-band RF filters for wireless applications, announced today a 13% year-over-year increase in quarterly revenue to a record $8.3 million for the fiscal quarter ended June 30, 2023, and record annual sales of $27.1 million, up 77% year-over-year.

With hundreds of active customers, increased activity in the sales and design win pipelines and the semiconductor services business, as well as new product introductions in Wi-Fi 6E and Wi-Fi 7, 5G network infrastructure and the defense market, the Company remains poised for significant growth over the next twenty-four months.

Akoustis will host an investor call to provide a business update and outlook, followed by a Q & A session, this morning at 8:00 am ET. The call-in numbers are 877-407-3982 (domestic) and +01 201-493-6780 (international). The conference call will be webcast live on the Company’s website and will be available for playback at the following URL: https://ir.akoustis.com/ir-calendar.

Jeff Shealy, founder and CEO of Akoustis, stated, “Despite the persistent macro challenges, Akoustis was able to deliver its seventh consecutive quarter of record revenue. Our sales growth was driven by multiple factors, including additional 5G mobile shipments to our first tier-1 customer, continued execution in our Wi-Fi business punctuated by the notable entry into the Wi-Fi 7 market, and rebounding sales in both our SAW filter and semiconductor services businesses.”

Akoustis continues to experience strong demand and a growing sales funnel for its XBAW® filter solutions, as well as its new XBAW^®/SAW resonator and oscillator products, and semiconductor back-end services. During the June quarter, the Company shipped samples of its new 5.6 GHz/6.6 GHz Wi-Fi 6E/7 XBAW^® filter products to multiple customers. Akoustis continues to add new Wi-Fi design wins, many of which are expected to ramp into production in fiscal 2024.

Recent Business Highlights

• Introduced new advanced single-crystal material and process that delivers significantly higher power handling and improved harmonics in BAW filters
• Sampled new advanced single-crystal filters to tier-1 enterprise-class Wi-Fi customer
• Launched a new state-of-the-art XBAW^® foundry service and AI-enabled engineering design software
• Successfully completed fab and OSAT audit with tier-1 smartphone/tablet OEM
• Delivered two new, custom Wi-Fi 7 filters to our tier-2 RF module making customer developed using our new, advanced foundry process
• Received four Wi-Fi design wins for Wi-Fi 6E and Wi-Fi 7 devices
• Began sampling our new 5.6/6.6 GHz Wi-Fi 6E/7 standard XBAW^® filter products
• Started production ramp with tier-1 US-based cable carrier company supporting Wi-Fi 6E
• Secured first Wi-Fi 7 design win from enterprise-class customer
• Received Wi-Fi 6E design win and started shipping into European carrier market
• Successfully delivered demonstrator samples of a new 7 GHz XBAW^® filter to a tier-1 European 5G network infrastructure OEM
• Awarded a development order for a new massive-MIMO filter design from a tier-1 European 5G network infrastructure OEM
• Introduced new automotive C-V2X filter and began sampling to multiple customers
• Delivered the second of two XBAW^® resonators for our first timing control customer
• Continued DARPA direct-to-phase II (DP2) contract to advance design and manufacturing of XBAW^® technology for filters and other sensors
• The Company’s XBAW^® patent portfolio grew to 104 issued and licensed patents, plus 108 patents pending as of August 25, 2023

Akoustis Technologies, Inc.

Fourth Fiscal Quarter Financial Performance

Akoustis Technologies, Inc.

Consolidated Statements of Operations

 (In thousands, except per share data)

	For the Three Months Ended	For the Twelve Months Ended	For the Three Months Ended	For the Twelve Months Ended
	06/30/23	06/30/23	06/30/22	06/30/22
Revenue
Revenue with Customers	$            8,333	$          27,121	$            5,203	$          15,350
Total revenue	8,333	27,121	5,203	15,350
Cost of revenue	10,037	30,237	6,666	19,487
Gross profit	(1,704)	(3,116)	(1,463)	(4,137)
Operating expenses
Research and development	8,165	33,243	10,132	35,708
General and administrative expenses	8,059	29,710	6,233	20,710
Loss on disposal of fixed assets	–	–	–	–
Impairment of assets held for sale	–	–	–	–
Total operating expenses	16,224	62,953	16,365	56,418
Loss from operations	(17,929)	(66,069)	(17,828)	(60,555)
Other (expense) income
Interest (expense) income	(367)	(2,322)	22	(77)
Rental income	–	–	–	–
Other income/(expense)	5	(8)	–	–
Change in fair value of contingent liability	6	1,446	(168)	(347)
Bargain purchase	–	–	–	–
Change in fair value of derivative liabilities	492	948	–	(48)
Total other (expense)  income	135	64	(145)	(472)
Income (loss) before income taxes	(17,794)	(66,005)	(17,974)	(61,027)
Income tax expense	(28)	(2,448)	92	(1,833)
Net Income (loss)	(17,765)	(63,557)	(18,065)	(59,194)
Net (income) loss attributable to noncontrolling interest	–	–	46	167
Net Loss attributable to Akoustis	(17,765)	(63,557)	(18,019)	(59,027)
Net loss per common share – basic and diluted	$              (0.25)	$              (1.00)	$              (0.32)	$              (1.09)
Weighted average common shares outstanding
-basic and diluted	71,741,166	63,621,727	56,561,053	54,021,205

Consolidated Balance Sheets

(In thousands, except per share data)

		June 30,				June 30,
		2023				2022
Assets
Assets:
Cash and cash equivalents		$	43,104			$	80,485
Accounts receivable			4,753				3,793
Inventory			7,548				4,094
Other current assets			4,440				3,359
Total current assets			59,845				91,731
Property and equipment, net			57,826				51,157
Goodwill			14,559				8,051
Intangibles, net			15,241				8,994
Operating lease right-of-use asset, net			1,374				1,126
Other assets			72				279
Total Assets		$	148,917			$	161,338
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses		$	17,027			$	11,204
Contingent consideration			—				855
Operating lease liability			439				313
Deferred revenue			105				286
Total current liabilities			17,571				12,658
Long-term Liabilities:
Convertible notes payable, net			43,347				43,731
Contingent consideration			—				591
Operating lease liability			976				811
Promissory note payable			667				—
Other long-term liabilities			117				117
Total long-term liabilities			45,107				45,250
Total Liabilities			62,678				57,908
Commitments and Contingencies (Note 15)
Stockholders’ Equity
Preferred Stock, par value $0.001: 5,000,000 shares authorized; none issued and outstanding			—				—
Common stock, $0.001 par value; 125,000,000 shares authorized; 72,154,647 and 57,079,347 shares issued and outstanding at June 30, 2023 and June 30, 2022, respectively			72				57
Additional paid in capital			356,522				310,171
Accumulated deficit			(270,355	)			(206,798	)
Total Stockholders’ Equity			86,239				103,430
Total Liabilities and Stockholders’ Equity		$	148,917			$	161,338

The following non-GAAP measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP. These non-GAAP measures exclude significant expenses that are required by GAAP to be recorded in the Company’s financial statements and are subject to inherent limitations. Please see reconciliations to comparable GAAP measures below and descriptions of these non-GAAP measures under “non-GAAP measures.”

Non-GAAP operating loss and non-GAAP net loss for the quarters ended June 30, 2023, and 2022 and for fiscal year 2023 and 2022 were as follows:

Akoustis Technologies, Inc.
Unaudited Reconciliations of Non-GAAP Financial Measures
	Three Months Ended
	June 30, 2023	June 30, 2022
(in thousands)
GAAP operating loss	$      (17,929)	$     (17,658)
Amortization of acquisition-related intangible assets	634	349
Recognition of acquisition-related promissory note	333	–
Gain on sale of fixed assets	5	(7)
Common stock issued for services	1,953	2,493
Non-GAAP operating loss	$      (15,004)	$     (14,823)
Weighted average common shares outstanding – basic and diluted	71,741,166	56,561,053
Non-GAAP operating loss per common share – basic and diluted	$          (0.21)	$         (0.26)
	Three Months Ended
	June 30, 2023	June 30, 2022
(in thousands)
GAAP net loss	$      (17,765)	$     (16,274)
Change in fair value of contingent consideration	(8)	168
Change in fair value of derivative liabilities	(492)	48
Amortization of acquisition-related intangible assets	634	349
Recognition of acquisition-related promissory note	333	–
Debt discount amortization	143	29
Gain on sale of fixed assets	5	(7)
Tax adjustments related to acquisitions	(28)	(1,772)
Common stock issued for services	1,953	2,493
Non-GAAP net loss	$      (15,226)	$     (14,967)
Weighted average common shares outstanding – basic and diluted	71,741,166	56,561,053
Non-GAAP net loss per common share – basic and diluted	$          (0.21)	$         (0.26)
	Twelve Months Ended
	June 30, 2023	June 30, 2022
(in thousands)
GAAP operating loss	$      (66,069)	$     (60,555)
Amortization of acquisition-related intangible assets	1,988	985
Recognition of acquisition-related promissory note	666	–
Gain on sale of fixed assets	(100)	(211)
Common stock issued for services	9,407	10,247
Non-GAAP operating loss	$       (54,108)	$     (49,534)
Weighted average common shares outstanding – basic and diluted	63,621,727	54,021,205
Non-GAAP operating loss per common share – basic and diluted	$            (0.85)	$          (0.92)
	Twelve Months Ended
	June 30, 2023	June 30, 2022
(in thousands)
GAAP net loss	$      (63,557)	$     (59,194)
Change in fair value of contingent consideration	(1,446)	347
Change in fair value of derivative liabilities	(948)	48
Amortization of acquisition-related intangible assets	1,988	985
Recognition of acquisition-related promissory note	666	–
Tax adjustments related to acquisitions	(2,448)	(1,772)
Gain on sale of fixed assets	(100)	(211)
Debt discount amortization	564	29
Common stock issued for services	9,407	10,247
Non-GAAP net loss	$       (55,874)	$      (49,521)
Weighted average common shares outstanding – basic and diluted	63,621,727	54,021,205
Non-GAAP net loss per common share – basic and diluted	$           (0.88)	$          (0.92)

Non-GAAP Measures

We regularly review a number of metrics, including non-GAAP operating loss and non-GAAP net loss, which are not financial measures calculated in accordance with generally accepted accounting principles in the United States (“GAAP”). Non-GAAP operating loss represents operating loss before common stock issued for services, amortization of acquisition-related intangible assets, recognition of acquisition-related promissory note, and gain or loss on the sale of fixed assets. Non-GAAP net loss represents net loss before change in fair value of contingent consideration, change in fair value of derivative liabilities, debt discount amortization, gain on extinguishment of debt, gain or loss on disposal of fixed assets, recognition of acquisition-related promissory note, amortization of acquisition-related intangible assets, tax adjustments related to acquisitions and common stock issued for services. The Company believes these non-GAAP measures provide useful information to management, investors, and financial analysts regarding certain financial and business trends relating to the Company’s financial condition and results of operations. We use these non-GAAP measures to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections, and make strategic decisions.

About Akoustis Technologies, Inc.

Akoustis^® (http://www.akoustis.com/) is a high-tech BAW RF filter solutions company that is pioneering next-generation materials science and MEMS wafer manufacturing to address the market requirements for improved RF filters – targeting higher bandwidth, higher operating frequencies and higher output power compared to legacy polycrystalline BAW technology. The Company utilizes its proprietary and patented XBAW^® manufacturing process to produce bulk acoustic wave RF filters for mobile and other wireless markets, which facilitate signal acquisition and accelerate band performance between the antenna and digital back end. Superior performance is driven by the significant advances of poly-crystal, single-crystal and other high purity piezoelectric materials and the resonator-filter process technology which enables optimal trade-offs between critical power, frequency and bandwidth performance specifications. 

Akoustis plans to service the fast growing, multi-billion-dollar RF filter market, using its integrated device manufacturer (IDM) business model. The Company owns and operates a 125,000 sq. ft. ISO-9001:2015 registered commercial wafer-manufacturing facility located in Canandaigua, NY, which includes a class 100 / class 1000 cleanroom facility – tooled for 150-mm diameter wafers – for the design, development, fabrication and packaging of RF filters, MEMS and other semiconductor devices. Akoustis Technologies, Inc. is headquartered in the Piedmont technology corridor near Charlotte, North Carolina.

Forward-Looking Statements

This document includes “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, each as amended, that are intended to be covered by the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements about our estimates, expectations, beliefs, intentions, plans or strategies for the future (including our possible future results of operations, profitability, business strategies, competitive position, potential growth opportunities, potential market opportunities and the effects of competition), the anticipated benefits of the acquisition of Grinding and Dicing Services, Inc., future cash flow and forecasts of breakeven point and expectations regarding funding under the CHIPS and Science Act, and the assumptions underlying such statements. Forward-looking statements include all statements that are not historical facts and typically are identified by use of terms such as “may,” “might,” “would,” “will,” “should,” “could,” “project,” “expect,” “plan,” “strategy,” “anticipate,” “attempt,” “develop,” “help,” “believe,” “think,” “estimate,” “predict,” “intend,” “forecast,” “seek,” “potential,” “possible,” “continue,” “future,” and similar words (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Forward-looking statements are neither historical facts nor assurances of future results, performance, events or circumstances. Instead, these forward-looking statements are based on management’s current beliefs, expectations and assumptions, and are subject to risks and uncertainties. Factors that could cause actual results to differ materially from those currently anticipated include, without limitation, risks relating to our inability to obtain adequate financing and sustain our status as a going concern; our limited operating history; our inability to generate revenues or achieve profitability;  the results of our research and development activities; our inability to achieve acceptance of our products in the market; the possibility that the anticipated benefits from business acquisitions (including the acquisition of Grinding and Dicing Services, Inc.) will not be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of acquired businesses’ operations will be greater than expected and the possibility of disruptions to our business during integration efforts and strain on management time and resources; the impact of a pandemic or epidemic or a natural disaster, including the COVID-19 pandemic, the Russian-Ukrainian conflict and other sources of volatility on our operations, financial condition and the worldwide economy, including its impact on our ability to access the capital markets; increases in prices for raw materials, labor, and fuel caused by rising inflation; general economic conditions, including upturns and downturns in the industry; shortages in supplies needed to manufacture our products, or needed by our customers to manufacture devices incorporating our products; our limited number of patents; failure to obtain, maintain, and enforce our intellectual property rights; claims of infringement, misappropriation or misuse of third party intellectual property, including the lawsuit filed by Qorvo, Inc. in October 2021, that, regardless of merit, could result in significant expense and negatively impact our business results; our inability to attract and retain qualified personnel; our reliance on third parties to complete certain processes in connection with the manufacture of our products; product quality and defects; existing or increased competition; our ability to successfully manufacture, market and sell products based on our technologies; our ability to meet the required specifications of customers and achieve qualification of our products for commercial manufacturing in a timely manner; our inability to successfully scale our New York wafer fabrication facility and related operations while maintaining quality control and assurance and avoiding delays in output; the rate and degree of market acceptance of any of our products; our ability to achieve design wins from current and future customers; contracting with customers and other parties with greater bargaining power and agreeing to terms and conditions that may adversely affect our business; risks related to doing business in foreign countries, including China; any security breaches, cyber-attacks or other disruptions compromising our proprietary information and exposing us to liability; our failure to innovate or adapt to new or emerging technologies, including in relation to our competitors; our failure to comply with regulatory requirements; results of any arbitration or litigation that may arise; stock volatility and illiquidity; dilution caused by any future issuance of common stock or securities that are convertible into or exercisable for common stock; our failure to implement our business plans or strategies; and our ability to maintain effective internal control over financial reporting. These and other risks and uncertainties are described in more detail in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the Company’s most recent Annual Report on Form 10-K and in subsequently filed Quarterly Reports on Form 10-Q. Considering these risks, uncertainties and assumptions, the forward-looking statements regarding future events and circumstances discussed in this document may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements included in this document speak only as of the date hereof and, except as required by law, we undertake no obligation to update publicly or privately any forward-looking statements, whether written or oral, for any reason after the date of this document to conform these statements to new information, actual results or to changes in our expectations.

Contact:

COMPANY:
Tom Sepenzis
Akoustis Technologies
VP of Corporate Development & IR
(980) 689-4961
[email protected]

TRV045 Demonstrated Statistically Significant Analgesic Effect in Capsaicin-induced Model of Neuropathic Pain in Target Engagement POC Study

TMS POC Study Provided Statistically Significant Evidence of CNS Activity of TRV045 on Day 4 as Measured by EEG Power Spectral Analysis

No SAEs and No Study Drug-Related Discontinuations were reported; Full Safety and Tolerability Data Expected in early 4Q 2023

Company to Hold Conference Call on Wednesday, September 6 at 8 a.m. Eastern

CHESTERBROOK, Pa., Sept. 06, 2023 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced preliminary topline data from two Phase 1 proof-of-concept studies of TRV045, a novel sphingosine-1-phosphate receptor modulator selective for the S1P receptor subtype 1.

“We’re very excited about the progress we’ve made with TRV045 and I’m pleased that both proof-of-concept studies demonstrated CNS target engagement. This dataset marks another significant milestone for Trevena and our ongoing commitment to focus on innovative new therapies,” said Carrie Bourdow, President and CEO of Trevena. “As a novel, non-opioid therapy, we believe TRV045 has the potential to make a meaningful difference in the lives of patients and we look forward to advancing TRV045, on our own or with a strategic partner, for potential treatment of neuropathic pain and other CNS disorders.”

Data from both studies demonstrated CNS penetration and target engagement, as well as plasma exposures in the anticipated active dose range, supporting the therapeutic potential of TRV045. In a capsaicin-induced neuropathic pain model, a validated model of neuropathic pain, TRV045 showed a statistically significant, dose-dependent treatment effect. In the transcranial magnetic stimulation (TMS) proof-of-concept study, TRV045 demonstrated statistically significant changes in the power spectral density in several bands.

“These preliminary studies strongly suggest to me that this compound has an impact on the central processing of pain, and is potentially working by reducing neural hyperexcitability,” said Daniel Clauw, MD, Professor of Anesthesiology, Medicine and Psychiatry at the University of Michigan. “There is a clear need for innovative new medications for the treatment of chronic pain. TRV045’s novel mechanism of action, accompanied by the early data suggesting it is well tolerated, make this an exciting new potential therapeutic approach.”

Target Engagement (PainCart^®) POC Study

The Target Engagement POC study was a randomized, double-blind, placebo-controlled, single dose four-way cross-over study (n=25 subjects) designed to evaluate evidence of target engagement for TRV045, using a select battery of pharmacodynamic outcomes. The study used the validated PainCart^® set of analgesic tests to evaluate potential central and peripheral nervous system effects and to provide insight into the potential anti-inflammatory actions of TRV045. Each subject received three different single doses of TRV045 (50mg, 150mg and 300mg) and placebo on four separate visits across the study duration. Plasma exposures of TRV045 in this study were comparable to levels seen in the previously reported Phase 1, FIH study and reached the anticipated targeted active dose range.

TRV045 demonstrated a statistically significant, dose-dependent reduction in mechanical allodynia following topical capsaicin application at 150mg and 300mg v. placebo. Allodynia was assessed by cutaneous pain sensation upon mechanical stimulation with Von Frey hair filaments, a validated model of neuropathic pain. The difference was measured for each dose of TRV045 compared to placebo as the change from baseline in both the secondary area of allodynic sensation and the total area of allodynia across 10 hours following the dose of study medication. The change from baseline in painful surface area at the final 10 hour timepoint is shown below, along with the associated P-values for each treatment difference across the entire 10 hour period of observation. Differences were evident for both the 150mg and 300mg doses beginning at hour 2 and continuing through the entire period of study observation at hour 10.

Outcome	Treatment	Change from Baseline in Painful Surface Area at Final 10 Hour Timepoint (mm 2 )*		P-Value for Overall Treatment Difference v Placebo
Total Allodynic Area (mm2)	Placebo	-67.19
	TRV045 50mg	-211.61		0.1844
	TRV045 150mg	-389.45		0.0002
	TRV045 300mg	-731.78		0.0001
Secondary Allodynic Area (mm2)	Placebo	-15.79
	TRV045 50mg	-54.98		0.5313
	TRV045 150mg	-186.14		0.0022
	TRV045 300mg	-393.05		0.0023

* Least squares (LS) mean change from baseline

TRV045 further demonstrated a dose-dependent trend in change from baseline in the cold pressor test, and also demonstrated trends in reduction to heat pain detection threshold on both unexposed and capsaicin-treated forearm skin, on heat pain detection threshold on unexposed skin on the upper back, and pain tolerance in the electrical burst stimulation test, though these endpoints did not achieve statistical significance. TRV045 did not show a statistically significant difference or trend compared to placebo in other pain modalities.

TMS POC Study

The TMS POC study was a randomized, double-blind, placebo-controlled, multiple dose, two-way cross-over study (n=25 subjects) designed to evaluate the pharmacodynamic effects of TRV045 (250mg) on cortical excitability in healthy male adults, using both EEG and EMG to measure the impact of TRV045 on the electrical excitation of the brain. The goal of the study was to provide further insight into TRV045 CNS target engagement and mechanism of action for the potential treatment of epilepsy and other CNS disorders. Each subject received one of two treatment sequences in random order: TRV045 at a dose of 250mg, followed by placebo; or placebo followed by 250mg of TRV045, each treatment sequence given once daily for four consecutive days. Plasma exposures of TRV045 in this study were comparable to levels seen in the previously reported Phase 1, FIH study and reached the anticipated targeted active dose range.

Among the EEG-related endpoints measured in the study, resting state EEG obtained before and after administration of TRV045, demonstrated statistically significant increases in the power spectral density on day 4 in several of the middle to higher frequency bands including alpha, beta and gamma waves. The changes in alpha waves are generally considered to be associated with conscious arousal and alertness, while beta waves are thought to be associated with GABA-mediated inhibitory cortical neurotransmission, and gamma waves are generally associated with cognitive processing, learning and memory. Alpha waves demonstrated this statistically significant increase in power in the frontal region (P=0.0164), as well as both left parietal (P=0.0047), and right parietal (P=0.0418) regions. This statistically significant increase in power was observed in the frontal region for beta waves (P=0.0235) and gamma waves (P=0.0343).

With respect to slow brain waves, which are generally associated with sedation or sleep, TRV045 showed a statistically significant decrease in the delta brain waves on day 4 in the right parietal region (P=0.0432), and no significant difference in theta brain waves at any of the three observed regions.

Among the EMG-related endpoints measured in the study, TRV045 demonstrated evidence of reduction in cortical excitability, as measured by change in peak motor-evoked potential (MEP) amplitude, on Day 1 comparable in magnitude to the reduction in cortical excitability reported in similar test conditions in the same laboratory for approved anti-epileptic drugs, though this result did not achieve statistical significance. There was no difference in mean peak MEP amplitude on Day 4, and no difference in resting motor threshold (RMT) on Day 1 or Day 4 or other EMG-related endpoints.

There were no serious adverse events reported, and no drug-related discontinuations from either study. Full safety and tolerability data for these studies are not yet available. This data is expected in early 4Q 2023. In the previously reported Phase 1 study of TRV045, the only adverse event assessed by study investigators as probably or definitely related to drug was headache in four subjects across all three parts of the study (n=53, n=27, n=9).

Subjects in both studies were enrolled outside of the United States, and the studies were not conducted under the Investigational New Drug Application for TRV045.

Conference Call and Webcast Information

The Company will host a conference call and webcast with the investment community on September 6, 2023 at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer, and Barry Shin, Chief Financial Officer.

Title:	Trevena Business Update Conference Call & Webcast
Date:	Wednesday, September 6, 2023
Time:	8:00 a.m. ET
Conference Call Details:	Toll-Free:1-877-704-4453 International:1-201-389-0920 Conference ID: 13740836
The conference call will be webcast live from the Company’s website and will be available via the following links:
Webcast:	https://viavid.webcasts.com/starthere.jsp?ei=1630911&tp_key=ea5c342481 https://www.trevena.com/investors/events-presentations/ir-calendar

The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website.

About TRV045

TRV045 is a novel, selective sphingosine-1-phosphate subtype 1 (S1P₁) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy.

S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.

Trevena’s discovery efforts have identified a family of compounds that are highly selective for the S1P₁ receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies. TRV045 is an investigational product and is not yet approved by the FDA.

About Epilepsy

Epilepsy, one of the most common neurological diseases in the world, is a chronic disorder characterized by recurrent seizures. Epilepsy is defined as having two or more unprovoked seizures separated by at least 24 hours or after one seizure with a high risk of more.

A seizure is a sudden surge of electrical activity in the brain caused by complex chemical changes that occur in nerve cells. Usually, there is a balance of cells that either encourage or stop other brain cells from sending messages. A seizure occurs when there may be too much or too little electrical activity in the brain causing an imbalance. Seizures are a symptom of many different disorders that can affect the brain. Nearly 50 million people suffer from epilepsy worldwide, including 3 million adults and 470,000 children in the U.S. 150,000 new cases of epilepsy are reported in the United States each year. According to the CDC, 56% of adults living with diagnosed epilepsy continue to have seizures.

About Diabetic Neuropathic Pain

Diabetic neuropathy is a common complication of both type 1 and type 2 diabetes, with pain in the extremities being one of the main symptoms. Other symptoms may include numbness, tingling, allodynia and hyperalgesia. Diabetic neuropathic pain is usually characterized as moderate to severe in nature and can substantially affect patients’ quality of life as well as their social and psychological well-being.

Approximately 25% of people with diabetes are affected by DNP, equaling over 5 million people in the U.S. During their lifetime, approximately 50% to 70% of diabetic patients may experience symptoms of DNP. 

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK^® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.

For more information, please visit www.Trevena.com 

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of discussions with FDA; available funding; uncertainties related to the Company’s intellectual property; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates and approved product; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

For more information, please contact:

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]
(617) 430-7576

Company Contact:

Bob Yoder
SVP and Chief Business Officer
Trevena, Inc.
(610) 354-8840

TORONTO and HOUSTON, Sept. 06, 2023 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (NASDAQ: MDNA TSX: MDNA), a clinical-stage immunotherapy company focused on the development of novel Superkines, announced that Dr. Fahar Merchant, President and CEO is scheduled to participate in a fireside chat at the H.C. Wainwright 25th Annual Global Investment Conference on September 13, 2023, at 2:30 PM ET.

The fireside chat will be live-streamed and available on the H.C. Wainwright Conference Platform for 30 days. Please contact your H.C. Wainwright representative for more information.

About Medicenna

Medicenna is a clinical-stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class class-empowered superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior CD122 (IL-2 receptor beta) binding without CD25 (IL-2 receptor alpha) affinity thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 clinical trials including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively. Medicenna’s early-stage BiSKITs™ program, (Bifunctional SuperKine ImmunoTherapies) is designed to enhance the ability of Superkines to treat immunologically “cold” tumors.

Further Information & Investor Contact:

For further information about the Company please contact:

Delphine Davan
Vice President, Investor Relations and Corporate Communications,
Phone: +1 (647) 474-2641
[email protected]

SALT LAKE CITY, Sept. 06, 2023 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in genetic testing and precision medicine, today revealed new nationwide survey results indicating widespread confusion and misconceptions about ovarian cancer screening among a majority of women.

The Myriad Genetics Cancer Risk survey shows that nearly three out of four women (71%) falsely believe annual pap smears include testing for ovarian cancer. According to the Centers for Disease Control and Prevention (CDC), the “only gynecologic cancer the Pap test screens for is cervical cancer.”

“Ovarian cancer is one of the deadliest forms of cancer for women due to the lack of screening techniques available and clinically specific symptoms. Many women believe they only need to visit every 3-5 years if they have a normal pap smear result,” said Ifeyinwa Stitt, MD, OB/GYN and medical director, Luminis Health in Annapolis, MD. “If women incorrectly believe having a normal pap equates to a low chance of ovarian cancer and don’t need an annual visit, this eliminates the opportunity for providers to annually screen for early symptoms and identify through abnormal pelvic exams. Knowledge of predisposing factors and surveillance is imperative to early detection which is key to ovarian cancer survival.” 

While almost half (47%) of the women surveyed believe they are being proactive when it comes to ovarian health, only 38% say they visited an OB-GYN in the past year and 13% say they have taken a genetic test to assess risk for cancer. For those who have not taken a genetic test, many women said they’d be motivated to get a genetic test if they had a high-risk of ovarian cancer based on family medical history (49%) or an immediate family member with ovarian cancer (38%).

Regardless of risk factors, 71% of the women surveyed believe all women should have genetic testing to determine ovarian cancer risk. Two out of three (66%) agree that knowing their risk will allow them to take more appropriate preventative measures and 58% agree knowing their risk will help their doctor more appropriately plan treatment should they get cancer.

“Our latest survey results underscore the dire need to break down any confusion about ovarian cancer, including symptoms and screening, to help women better understand their cancer risk and how to take appropriate preventative measures,” said Melissa Gonzales, president of women’s health, Myriad Genetics. “Listening to your body, having open conversations with your doctor and knowing your family history are essential in this quest. For women with elevated risk factors, genetic testing can be a helpful tool that provides a cancer risk assessment personalized to them.”

For more information about Myriad’s hereditary cancer test and risk assessment, MyRisk^® Hereditary Cancer Test with RiskScore^®, please visit: https://myriad.com/genetic-tests/myrisk-hereditary-cancer-risk-test/.

About Myriad Genetics Cancer Risk nationwide survey

Myriad Genetics Cancer Risk Survey is a nationwide poll conducted online by ACUPOLL Precision Research, Inc. in from June 20-29, 2023 among a statistically representative sample (n=1632) of U.S. females age 18+. The survey included a representative sample of women at high-risk for breast or ovarian cancer. The margin of error in survey results for the total base population at a 95% confidence interval is +/- 3%.

About MyRisk
^®
Hereditary Cancer Test with RiskScore
^®

MyRisk with RiskScore evaluates 48 genes associated with hereditary cancer risk to identify genetic changes associated with an increased cancer risk. When combined with family history and other clinical factors, MyRisk with RiskScore provides each patient with a cancer risk assessment individualized to them.

About Myriad Genetics

Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.

Media Contact: Glenn Farrell (385) 318-3718 [email protected]

Investor Contact: Matt Scalo (801) 584-3532 [email protected]

MIDDLETOWN, R.I., Sept. 06, 2023 (GLOBE NEWSWIRE) — Today, KVH Industries, Inc., (Nasdaq: KVHI), announced that it is adding Starlink to its service portfolio. KVH will sell Starlink on its own and also as a KVH ONE^™ global network companion service. KVH, a leading provider of intelligent hybrid connectivity for maritime applications, will serve as an authorized Starlink reseller and integrator for commercial and leisure vessels.

“Starlink is a valuable addition to our hybrid connectivity portfolio,” said Brent Bruun, KVH’s chief executive officer. “Our intelligent hybrid design enables us to switch seamlessly among Starlink and both the KVH TracNet^™ and TracPhone^® terminals for outstanding and affordable communications. As a result, fleets and yachts worldwide will enjoy optimal, reliable connectivity together with KVH’s premier 24/7 support, business-critical applications, and service level commitments.”

Starlink offers high-speed, low-latency Internet using a high-performance electronically steered flat panel array. KVH’s TracNet terminals feature satellite, cellular, and Wi-Fi interconnectivity under one dome, with intelligent, automatic switching to continually deliver the best performance. Thanks to plug-and-play integration, that same intelligent hybrid switching will ensure that customers take full advantage of Starlink in combination with the KVH ONE network for uninterrupted connectivity worldwide.

Note to Editors: High-resolution images of KVH products are available at the KVH Press Room Image Library, https://www.kvh.com/imagelibrary.

About KVH Industries, Inc.

KVH Industries, Inc. is a global leader in mobile connectivity and maritime VSAT delivered via the KVH ONE network. The company, founded in 1982, is based in Middletown, RI, with research, development, and manufacturing operations in Middletown, RI, and more than a dozen offices around the globe. KVH provides connectivity solutions for commercial maritime, leisure marine, military/government, and land mobile applications on vessels and vehicles, including the TracNet, TracPhone, and TracVision^® product lines, the KVH ONE OpenNet Program for non-KVH antennas, AgilePlans^® Connectivity as a Service (CaaS), and the KVH Link crew wellbeing content service.

This press release contains forward-looking statements that involve risks and uncertainties. For example, forward-looking statements include statements regarding the expected benefits to KVH customers of the KVH Starlink Companion Product. Actual results could differ materially from the forward-looking statements made in this press release. Factors that might cause these differences include, but are not limited to: unanticipated technical and other challenges that arise with the services; unanticipated technical or legal delays with the services; customer and strategic partner responses; potential future changes to the pricing or other terms; and potential unforeseen costs or expenses of providing the products and services. Other factors are discussed in more detail in KVH’s Annual Report on Form 10-K filed with the SEC on March 16, 2023, and our Quarterly Report on Form 10-Q filed with the SEC on August 9, 2023. Copies are available through its Investor Relations department and website, investors.kvh.com. KVH does not assume any obligation to update its forward-looking statements to reflect new information and developments.

KVH Industries, Inc., has used, registered, or applied to register its trademarks in the USA and other countries around the world, including but not limited to the following marks: KVH, KVH ONE, TracVision, TracPhone, TracNet, and AgilePlans. Other trademarks are the property of their respective companies.

For further information, please contact:

Chris Watson
Vice President, Marketing & Communications
KVH Industries, Inc.
Tel: +1 401 845 2441
[email protected]

IRVINE, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the publication of a study evaluating tegoprubart as an immunomodulatory monotherapy in nonhuman primate kidney and islet allotransplants. The study, entitled “The anti-CD40L monoclonal antibody AT-1501 promotes islet and kidney allograft survival and function in nonhuman primates”, was published in the August 30, 2023, issue of Science Translational Medicine.

Results from the study showed that treatment with tegoprubart as a monotherapy promoted long-term kidney and islet allograft survival and function in nonhuman primates, indicating its potential as an immunomodulatory agent for organ transplantation. In the study, tegoprubart did not bind to Fc receptors or promote platelet aggregation in vivo, thereby minimizing the risk of thromboembolic complications, while also retaining a high binding affinity to CD40L. Additionally, phenotypes of both CD4+ and CD8+ cells remained similar throughout the study.

“These findings published in Science Translational Medicine further support our hypothesis that Eledon’s anti-CD40L antibody, tegoprubart, has the potential to play a crucial role in modulating the immune system to help protect transplanted organs and thereby promote graft function and survival in kidney transplant patients,” said Dr. Steve Perrin, Eledon’s President and Chief Scientific Officer. “We look forward to presenting additional tegoprubart human data in kidney transplantation at Kidney Week in November.”

Eledon recently initiated the BESTOW study, a phase 2 study enrolling approximately 120 participants undergoing kidney transplantation to assess the efficacy and safety of tegoprubart compared to the standard of care (tacrolimus). The Company previously reported clinical data at the World Congress of Nephrology from its ongoing Phase 1b study evaluating tegoprubart in kidney transplantation, demonstrating no incidence of acute rejection and strong graft function in the first three enrolled participants. Eledon expects to report updated clinical data from the Phase 1b study at the American Society of Nephrology (ASN) Kidney Week Annual Meeting in November 2023.

About Eledon Pharmaceuticals and tegoprubart (formerly AT-1501)

Eledon Pharmaceuticals is a clinical stage biotechnology company using its immunology expertise to develop therapies that protect transplanted organs and prevent organ rejection, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about planned clinical trials and the Company’s other future expectations, plans and prospects, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals