Biotechnology Archives - Page 23 of 55

Release – GeoVax Receives BARDA Project NextGen Award to Conduct Phase 2b Clinical Study Evaluating the Company’s Next-Generation COVID-19 Vaccine Candidate, GEO-CM04S1

Posted on June 18, 2024June 18, 2024 by aweinsoff@channelchek.com

10,000-participant randomized Phase 2b study will evaluate and compare GeoVax’s multi-antigen, vaccine candidate (GEO-CM04S1) to an approved vaccine against COVID-19 under BARDA’s Clinical Studies Network

Project NextGen is a $5 billion initiative by the U.S. Department of Health and Human Services to develop innovative vaccines and therapeutics providing broader and more durable protection against current and future COVID-19 viral strains

Atlanta, GA, June 18, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. Preparations for the study are underway, and execution of the study will be fully funded by BARDA under its Clinical Studies Network.

The direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made separate awards through its Clinical Studies Network to support execution of the study. That funding will represent approximately $343M from the Project NextGen program for a CRO to execute the clinical trial using GeoVax’s vaccine.

“We are honored and proud to receive this award from BARDA to advance our next-generation vaccine against COVID-19. This contract not only provides the vital resources for advancing the development of GEO-CM04S1, but it also advances our MVA platform in infectious diseases,” said David Dodd, Chairman & CEO of GeoVax.

Mr. Dodd continued, “First-generation COVID-19 vaccines were beneficial during the peak of the pandemic but are limited in breadth and durability of clinical protection, requiring frequent updates. Now that COVID-19 is in an endemic stage, many people continue to have their everyday lives impacted in meaningful ways. Furthermore, there are an estimated 23 million adults in the U.S. with immunocompromised conditions who are less likely to have an adequate response to current vaccines and are more likely to potentially experience severe COVID-19 symptoms, hospitalization and the risk of death, even after vaccination. GEO-CM04S1 was designed to address these limitations by inducing durable neutralizing antibody and T-cell-based immunity against current and future SARS-CoV-2 variants. Our vaccine has continued to demonstrate induction of potent immune responses with potential to drive broad and durable clinical protection, and we eagerly anticipate commencing the Phase 2b study to further demonstrate the value and advantages of our technology.”

Funding for this award is provided under Project NextGen, a $5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first generation COVID vaccines and medicines. BARDA is supporting the development of new vaccines and therapeutics to better address the waning immunity and resistance to current and future SARS-CoV2 viral strains. GeoVax’s vaccine candidate provides many of the features identified by BARDA including broader protection among variants of concern (VOC) and a longer duration of protection.

This project is being funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number: 75A50123D00005.

About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T-cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.

GEO-CM04S1 is currently being evaluated in three ongoing Phase 2 clinical trials:

As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. A recent presentation of unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T-cell responses.
As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
As a booster vaccine for healthy adults who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, which recently completed enrollment in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:	Investor Relations Contact:	Media Contact:
info@geovax.com	austin.murtagh@precisionaq.com	sr@roberts-communications.com
678-384-7220	212-698-8696	202-779-0929

GeoVax Labs (GOVX) – GeoVax Receives BARDA Award For COVID Vaccine Trial

Posted on June 18, 2024June 18, 2024 by cpereira@noblefcm.com

Tuesday, June 18, 2024

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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

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Grant Provides Up To $367 Million Funding For The Phase 2b Trial. GeoVax announced that it has been selected to receive a Project NexGen grant to test CM04S1 in a Phase 2b study for prevention of COVID-19. The study will test CM04S1 against an approved vaccine in a randomized trial enrolling 10,000 volunteers. GeoVax will receive about $24.3 million for manufacturing, materials, and trial preparations, which can be increased to $45 million. About $343 million will be awarded to a CRO to conduct the trial.

Phase 2b Trial Will Have A Large Enrollment. The trial is designed as a Phase 2b double-blind study comparing GeoVax CM-04S1 to an approved mRNA COVID-19 vaccine. Enrollment will have an estimated 10,000 healthy volunteers to determine efficacy, safety, and immunogenicity of the vaccines. Previous trials with CM04S1 have shown both humoral and cellular immunity to multiple strains of the SARS-CoV-2 virus, with rapid and durable protection.

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Healthcare AI Trailblazer Tempus Goes Public in $410 Million Offering

Posted on June 14, 2024June 14, 2024 by slightbourne@noblecapitalmarkets.com

The artificial intelligence revolution is rapidly expanding into new industries and sectors. While AI has already transformed fields like consumer technology and autonomous vehicles, one area holding immense potential for disruption is healthcare. A new public company, Tempus AI, is looking to capitalize on this opportunity at the intersection of artificial intelligence and precision medicine.

Tempus, based in Chicago, priced its initial public offering on Thursday, raising $410.7 million by selling 11.1 million shares at $37 each. With this successful IPO, the AI healthcare company now carries a fully diluted market valuation around $8 billion as a newly minted public enterprise. Tempus also granted underwriters a 30-day option to purchase an additional 1.665 million shares.

The sizeable offering highlights immense investor demand for companies leveraging artificial intelligence to solve major challenges across different domains. AI and machine learning firms have seen warm receptions on the public markets over the last couple of years as the powerful capabilities of these technologies have become more apparent and applicable.

However, Tempus represents one of the first opportunities for public investors to gain exposure to the rapidly evolving field of AI-driven precision medicine and healthcare applications. The company aims to use artificial intelligence models to provide decision support tools that enable doctors to offer more personalized care tailored specifically to each patient’s condition and circumstances.

Underpinning Tempus’ AI healthcare platform is its multimodal database containing a massive repository of data aggregated from healthcare providers across the country. This includes molecular data, medical images, electronic records, and treatment information across millions of patient lives for major disease areas like cancer, diabetes, neurological disorders and more.

Tempus deploys proprietary artificial intelligence models that ingest and learn patterns from this immense, constantly updating dataset. These AI models can then provide personalized analysis and therapeutic recommendations to physicians treating patients. On the life sciences side, pharmaceutical companies pay to access Tempus’ data and AI capabilities to aid in drug discovery and development of new therapies.

The core premise is that Tempus’ operating system for precision medicine becomes smarter and more powerful with every new data point added. This sets up a virtuous learning cycle where the AI models help enable better patient outcomes, leading to more data to further enhance the predictive prowess of the AI over time.

While still a relatively small company generating around $100 million in revenue for 2023, Tempus has grand ambitions to help usher in an era of AI-augmented healthcare. The company envisions its technology empowering doctors to defeat deadly diseases through intelligent, data-driven treatment strategies precisely tailored to each individual patient’s unique molecular profile.

Tempus’ successful public offering provides a major cash influx to fund investments and growth initiatives as it aims to cement itself as a pioneer in the burgeoning field of AI healthcare applications. For investors seeking exposure to AI’s transformative potential across sectors, the newly public Tempus may offer an intriguing option to capitalize on precision medicine powered by artificial intelligence.

Only time will tell if Tempus can fully deliver on its bold vision. But the company’s lucrative public debut underscores big expectations that AI could play a pivotal role in ushering healthcare into a new technologically-advanced frontier of personalized patient care and therapeutic development in the years ahead.

Take a moment to take a look at more emerging growth healthcare investment ideas on display at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference.

Could These 5 Micro-Cap Sectors Be the Next Big Thing?

Posted on June 13, 2024June 13, 2024 by slightbourne@noblecapitalmarkets.com

In the ever-evolving world of investing, savvy investors are constantly on the hunt for opportunities that offer the potential for outsized returns. While large-cap companies often dominate the spotlight, it’s the micro-cap universe that harbors some of the most exciting and undiscovered investment prospects. With market capitalizations typically ranging from $50 million to $300 million, these pint-sized powerhouses can pack a punch for those willing to navigate their inherent risks and volatility. In this article, we’ll explore the top micro-cap sectors that astute investors should have on their radar.

Technology
The technology sector has long been a breeding ground for micro-cap innovation, and the rise of artificial intelligence (AI) has added another compelling opportunity. From software-as-a-service (SaaS) companies revolutionizing business processes to cybersecurity firms safeguarding our digital lives, micro-caps in this space are at the forefront of disruption. As businesses embrace AI capabilities, micro-cap tech companies developing cutting-edge AI solutions could experience exponential growth, making them attractive targets for investors seeking outsized returns.

Healthcare and Biotech
The healthcare and biotech sectors are teeming with micro-cap companies pursuing groundbreaking treatments and medical devices. While the risks are undoubtedly high, with many drug candidates failing to reach commercialization, the potential rewards for successful micro-cap biotech firms can be staggering. From gene therapies to novel diagnostic tools, these micro-caps could revolutionize patient care and generate substantial returns for early investors.

Natural Resources
As the global demand for natural resources continues to surge, micro-cap companies in the mining, oil and gas, and agriculture sectors could present lucrative opportunities. Micro-cap mining firms with promising mineral deposits or innovative extraction technologies may capture significant value as commodity prices fluctuate. Similarly, micro-cap oil and gas companies leveraging cutting-edge drilling or fracking techniques could capitalize on energy market dynamics.

Manufacturing and Industrials
The manufacturing and industrials sectors are ripe with micro-cap companies offering innovative solutions to enhance productivity, automate processes, and streamline operations. From advanced robotics and automation technologies to cutting-edge materials and components, these micro-caps could experience significant growth as manufacturers seek to gain a competitive edge.

Consumer and Retail: Riding the Wave of Disruption
The consumer and retail sectors are breeding grounds for micro-cap disruptors challenging established brands and business models. From emerging consumer brands tapping into niche markets to e-commerce and subscription-based retailers reshaping the shopping experience, these micro-caps have the potential to capture significant market share and generate substantial returns.

Navigating the micro-cap universe requires a keen eye for potential, a appetite for risk, and unwavering patience. However, for investors willing to put in the effort and embrace a long-term mindset, the rewards can be substantial. By maintaining a diversified portfolio across these promising micro-cap sectors, conducting thorough due diligence, and staying attuned to emerging trends and catalysts, savvy investors can unearth hidden gems before they capture the spotlight. While the journey may be full of twists and turns, the ability to identify and capitalize on the next big thing can separate the micro-cap maestros from the masses. Embrace the thrill of the hunt, and let your passion for discovering untapped potential be your guide through the exciting realm of micro-cap investing.

Release – MAIA Biotechnology’s Telomere Targeting Functionality Is Shown Viable By FDA’s Approval Of A Telomerase Inhibitor Agent Therapy

Posted on June 7, 2024June 7, 2024 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

June 07, 2024 12:31pm EDTDownload as PDF

FDA move illuminates key role of telomere targeting as a viable therapeutic strategy for cancer treatment

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage company developing telomere-targeting immunotherapies for cancer, today announced the validation of clinical and regulatory pathways for viable therapies leveraging the cell’s telomeric functions as evidenced by the U.S. Food and Drug Administration (FDA) approval of imetelstat, a treatment for low- to intermediate-risk hematologic malignancies (myelodysplastic syndromes) from Geron Corporation.

“MAIA is one of the earliest pioneers of telomere targeting as a therapeutic strategy, and we share in the enthusiasm for the FDA approval of imetelstat for rare blood cancers originating in bone marrow. We have found that telomere targeting as a mechanism of action plays a key role in treating certain cancers, and we are studying this science in our Phase 2 trial of THIO in high-risk non-small cell lung cancer (NSCLC),” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “Our most recent clinical data shows THIO’s exceptional efficacy in checkpoint inhibitor and chemo-resistant patients in NSCLC. We salute Geron for validating the pathway,” concluded Dr. Vitoc.

Telomerase is present in over 85% of human cancers and contributes significantly to the proliferation and reproductive immortality of cancer cells. MAIA’s lead candidate is THIO, a telomere targeting agent in clinical development (Phase 2 THIO-101) to evaluate its activity in NSCLC. THIO is recognized by telomerase and incorporated into telomeres in cancer cells. Once incorporated, THIO compromises the telomere structure and function, leading to ‘uncapping’ of the chromosome ends and thus resulting in rapid tumor cell death.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

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.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240607677531/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released June 7, 2024

Medtech Industry Heats Up as KARL STORZ Acquires Surgical Robotics Firm Asensus

Posted on June 7, 2024June 8, 2024 by slightbourne@noblecapitalmarkets.com

The medtech deal landscape just got a major shake-up with medical technology giant KARL STORZ announcing it will acquire surgical robotics company Asensus Surgical for $0.35 per share in cash. The $775 million transaction represents a significant premium for Asensus shareholders and will create a new leader in robotic surgery systems within KARL STORZ’s vast product portfolio.

The acquisition highlights the intense interest and competition around next-generation surgical robotics platforms. KARL STORZ is doubling down on the space by bringing Asensus and its augmented intelligence technologies in-house to enhance its robotic surgery offerings, particularly the promising LUNA system Asensus had in development.

For the medtech sector and investors, this high-profile deal carries several implications:

Robotic Surgery Becomes Key Priority
KARL STORZ’s major bet on Asensus signals just how strategically important robotic-assisted surgery has become for medtech companies. The ability to market cutting-edge robotic platforms that improve precision and outcomes is now table stakes in many areas of surgery.

Medtechs involved in supporting technologies like visualization, data integration, and procedural automation should see increased interest and investment from larger players looking to beef up their surgical robotics capabilities. KARL STORZ’s acquisition also puts increased pressure on peers like Intuitive Surgical and Stryker to stay ahead of the innovation curve.

More Consolidation Could Follow
Billion-dollar acquisitions often beget more deals as competitors look to keep pace and buttress their own product portfolios. This could kick off another wave of M&A in the surgical robotics space specifically, with smaller innovative companies becoming prime targets for medtech incumbents.

But beyond just robotics, KARL STORZ’s aggressive move may spur more consolidation across the broader medtech landscape. Major strategic buyers have been a bit apprehensive on M&A recently. This deal could provide a catalyzing force for other medtechs, pharmaceuticals, and life science companies to start getting more acquisitive, especially with several cutting-edge names trading at more attractive valuations.

Public Listing Exits Will Continue
By taking Asensus private, KARL STORZ adds another data point to the growing trend of medtech companies going private or getting acquired by larger players. With the IPO markets effectively shuttered and sustaining a public listing increasingly difficult for many small-to-mid-sized medtechs, a lucrative exit via acquisition could become the preferred route.

Investors may need to adjust expectations and position accordingly. Rather than holding out for the “next big IPO,” top-performing private medtech holdings may deliver the biggest windfall by positioning to get scooped up via M&A premium valuations down the road.

Capital Allocation Will Be Key
The KARL STORZ-Asensus transaction underscores how critically important prudent capital allocation and portfolio management will be for medtech investors. The 67% premium paid by the German firm highlights the potential upside for backing innovative, promising names before they get acquired.

But it also serves as a reminder of the downside risks – making the wrong medtech bets can lead to significant impairment if firms struggle to remain viable acquisition targets or get their technologies to market successfully. Having robust processes to separate the wheat from the chaff across the medtech universe will be paramount moving forward.

KARL STORZ’s acquisition of Asensus represents both an ambitious strategic move for the medical device titan and an intriguing data point for medtech investors to digest. As the broader life science space continues rapidly evolving, this landmark M&A deal provides some insight into the developing landscape that savvy medtech investors will need to navigate adeptly.

Rare Disease Pharma Play: Cycle Bids $466M for Vanda

Posted on June 6, 2024June 6, 2024 by slightbourne@noblecapitalmarkets.com

Cycle Pharmaceuticals Ltd., a rapidly growing pharmaceutical company laser-focused on rare diseases, has set its sights on acquiring Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) for $8.00 per share in an all-cash transaction valuing Vanda at $466 million.

The unsolicited proposal, disclosed publicly on June 6th, represents an attractive 98% premium to Vanda’s share price prior to an earlier $4.05 per share acquisition offer from Future Pak LLC announced in April. Cycle’s $8.00 bid also represents a 58% premium to Vanda’s closing price on June 5th.

Vanda, which has been publicly traded since 2006, currently markets therapies for sleep disorders, jet lag, and schizophrenia, with additional pipeline candidates in development. The company’s shares have struggled over the past year, trading as low as $3.30 before the Future Pak offer surfaced.

Cycle was founded in 2012 with the sole mission of developing and commercializing treatments for underserved rare disease patients. The company has quickly built an arsenal of six approved drugs, including recent U.S. launches of TASCENSO ODT for multiple sclerosis in 2023 and TIOPRONIN for a rare metabolic disorder in 2024.

In disclosing its proposal publicly, Cycle cited its “extensive U.S. operational footprint and distribution,” stating this makes it “a strong strategic fit” to maximize the value of Vanda’s commercial products and pipeline. Cycle reported $109 million in 2023 net sales and $40 million in operating profits.

The proposal represents “immediate, compelling and certain cash value” for Vanda shareholders according to Cycle. Its $8.00 per share cash bid exceeds the cash component of Future Pak’s most recent $23 per share revised offer on May 7th, which included stock and contingent value rights.

Cycle stated it has substantial cash reserves on hand and is highly confident it can secure committed debt financing for the transaction after limited due diligence. The firm is aiming to complete diligence within 2-3 weeks and finalize a definitive merger agreement shortly thereafter.

While Cycle stated a preference to reach an agreement privately with Vanda’s board, it has gone public with its proposal “for the benefit of Vanda shareholders” to encourage them to voice support for the premium cash bid.

The rare disease focus of both companies could make this an intriguing strategic fit, while Cycle’s bold premium cash offer puts the onus on Vanda’s board to either embrace this higher-valued bid or make a compelling case that greater long-term value could be unlocked by rejecting it. Regardless, this acquisition play instantly ratchets up the stakes in Vanda’s strategic review process.

Cadrenal Therapeutics (CVKD) – Data Presentation From LVAD Study Points Out The Need For Tecarfarin

Posted on June 5, 2024June 5, 2024 by cpereira@noblefcm.com

Wednesday, June 05, 2024

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.

Patients With LVADs Need A New Anticoagulant. A new analysis of anticoagulant regimens from a study in cardiovascular devices patients was presented at the International Society of Heart and Lung Transplantation Annual Meeting. The presentation included data from the ARIES-HM3 study testing anticoagulation with warfarin and aspirin against warfarin alone. We believe the data highlights the need for tecarfarin in left ventricular assist device (LVAD) patients.

Abbott Has An Interest In LVAD Patient Outcomes. The ARIES-HM3 study was sponsored by Abbott (ABT, Not Rated), maker of the HeartMate3 LVAD. Patients with these devices cannot take DOAC anticoagulant drugs, leaving them with only warfarin. The study tested warfarin (a vitamin K antagonist, VKA) with and without aspirin. The findings showed lower time in the therapeutic range (TTR) is a predictor of excessive bleeding events, and warfarin patients are typically below target values.

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Release – Eledon Presents Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation

Posted on June 4, 2024June 4, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

June 3, 2024

PDF Version

Data from 13 participants presented at the American Transplant Congress continue to support safety and tolerability profile of tegoprubart

Overall mean eGFR of all reported time points after day 30 post-transplant of 70.5 mL/min/1.73m²

Mean eGFR measured above 60 mL/min/1.73m² at all reported time points after day 30 post-transplant

IRVINE, Calif., June 03, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today presented updated data from the Company’s ongoing open-label Phase 1b trial and open-label extension study evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the poster, titled “Biomarkers of Inflammation and eGFR in an Ongoing Phase 1B Study of an Anti-CD40L Antibody Tegoprubart, for the Prevention of Rejection in Kidney Transplant,” were presented at the American Transplant Congress (ATC) taking place in Philadelphia, PA from June 1-5, 2024.

“Eledon continues to build a robust set of encouraging results demonstrating the safety and efficacy of tegoprubart in kidney transplant recipients in our Phase 1b trial,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Calcineurin inhibitors, the current standard of care, do not adequately serve the transplant community due to frequent and difficult–to-manage side effects. By contrast, tegoprubart’s observed clinical profile to date gives us confidence in its potential to supplant calcineurin inhibitors as a next-generation immunosuppression agent for patients who have received a new kidney. We look forward to accruing incremental data through the ongoing Phase 1b and open-label extension studies while continuing to enroll in our Phase 2 BESTOW trial, with enrollment completion anticipated by the end of the year.”

As of the April 2024 cutoff date, updated data from the 13 participants in the ongoing Phase 1b trial support tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation. Data from historical studies using standard of care, calcineurin inhibitor-based immunosuppression therapy typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 50 mL/min/1.73m² during the first year after kidney transplant. In the ongoing Phase 1b trial, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant. Two participants completed 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one-year post-transplant.

Results demonstrated that tegoprubart is generally safe and well tolerated in patients undergoing de novo kidney transplantation. Three subjects have discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively. There have been no cases of hyperglycemia, new onset diabetes, or tremor, all of which are side effects often associated with standard of care immunosuppression therapy. There have been no cases of graft loss or death.

Eledon is currently conducting a Phase 1b trial (NCT05027906), a Phase 2 trial (BESTOW; NCT05983770), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

A copy of the ATC poster can be found on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). 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 the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, 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 sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. 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
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Source: Eledon Pharmaceuticals, Inc.

Release – MAIA Biotechnology Reveals New Clinical Data Showing THIO’s Strong Efficacy In Non-Small Cell Lung Cancer

Posted on June 4, 2024June 4, 2024 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

June 04, 2024 8:41am EDTDownload as PDF

THIO’s favorable disease control and overall response rates exceed reported standard-of-care data in third line treatment

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced new efficacy data from its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens. Updated results show a favorable overall response rate (ORR) of 38% and a disease control rate (DCR) of 85% from THIO + CPI in third-line treatment. The new data was presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on June 3, 2024.

The primary objectives of THIO-101 Phase 2 trial are to examine the safety and tolerability of THIO as an anticancer drug and as an immune system primer, and to examine the clinical efficacy of THIO in the form of ORR. At the time of the most recent data cut-off (April 30, 2024), all evaluable patients had completed ≥1 post-baseline assessment.

Results from third-line treatment:

Disease control rate (DCR) was 85% for THIO vs. standard of care DCR of 25–35% for chemotherapy¹
65% of patients crossed the 5.8-month overall survival (OS) threshold²
85% of patients crossed the 2.5-month progression-free survival (PFS) threshold^3-4
Median survival follow-up time is currently 9.1 months (n=20)

Results from third-line treatment with THIO 180mg (optimal dose selection)

Median PFS of 5.5 months (24.1 weeks)
78% OS rate at 6 months
38% ORR vs. standard of care 6–10% for chemotherapy²
75% of patients crossed the 5.8-month OS threshold²
88% of patients crossed the 2.5-month PFS threshold^3-4
Median survival follow-up time is currently 9.1 months (n=8)

¹ Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89.
² Girard N, et al. J Thorac Onc 2009;12:1544-1549.
³ Shepherd F, et al. N Engl J Med 2005;353:123-132.
⁴ Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.

“All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard of care treatments,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “The data presented at ASCO advances THIO’s excellent clinical profile as a strong, safe, and highly effective alternative for patients who progressed following chemotherapy and other available treatments. We eagerly anticipate full efficacy data from THIO-101 in the second half of this year.”

To date, treatment with THIO + cemiplimab has been generally well tolerated in a heavily pre-treated patient population. Full enrollment in THIO-101 was completed on February 19, 2024, earlier than expected as per trial design. The Company expects that THIO-101 will be the first completed clinical study of a telomere targeting agent in the field of cancer drug discovery and treatment.

The poster and updated Company presentations can be accessed on the company’s website.

About THIO

About THIO-101, a Phase 2 Clinical Trial

About MAIA Biotechnology, Inc.

Forward Looking Statements

View source version on businesswire.com: https://www.businesswire.com/news/home/20240604727806/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released June 4, 2024

Eledon Pharmaceuticals (ELDN) – Data Update From Phase 1b Trial Shows Continued Tegoprubart Benefits

Posted on June 4, 2024June 4, 2024 by slightbourne@noblecapitalmarkets.com

Tuesday, June 04, 2024

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 From Phase 1b Trial Updated. Eledon presented data from the Phase 1b trial testing tegoprubart, its drug for prevention of kidney transplant rejection, at the American Transplant Congress. We found the data to continue to show improved kidney function during the first year after transplantation, a strong indicator of organ survival, with continued safety and tolerability.

Kidney Function Measures Continue To Show Improvements Over Tacrolimus. The Phase 1b data included 13 patients who had reached 30-day post-transplant evaluation. Their mean eGFR was above 60 mL/min/1.73m² at each reported time point. The overall mean eGFR after day 30 reached 70.5 mL/min/1.73m². This is an improvement over standard-of-care immunosuppressive regimens that have eGFR rates around the 50ml/min/1.73m² level during the first year after the transplant.

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Release – Data And Safety Monitoring Board Approves Simultaneous Enrollment In Cohort 3 And Phase 2 Initiation In OCU410 ArMaDa Study For Geographic Atrophy

Posted on May 31, 2024May 31, 2024 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 31, 2024

Established Medium Dose as Safe and Tolerable Dose in Current OCU410 Clinical Trial
DSMB Recommends Continuing with High-Dose Cohort Dosing with Concurrent Phase 2 Dosing

MALVERN, Pa., May 31, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced a positive outcome of the Data and Safety Monitoring Board (DSMB) Review for its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV5-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 2-3 million people in the U.S. and Europe combined.

Six subjects with GA were dosed in the Phase 1/2 clinical trial to date—three subjects were dosed with the low dose and three subjects were dosed with the medium dose. An additional three patients will be dosed with the high dose of OCU410 in the dose-escalation phase.

“The DSMB has recommended to proceed with dosing subsequent GA subjects with the high dose of OCU410 in the dose-expansion phase of the study and concurrently initiate Phase 2 dosing,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial. “No serious adverse events (SAEs) related to OCU410 have been reported to date in both low- and medium-dose cohorts. I believe that this marks a critical next step towards determining the maximum tolerated dose for OCU410 and is an important milestone for its clinical development.”

“We are delighted to report a second positive DSMB recommendation for the treatment of GA, which significantly builds on the favorable safety and tolerability profile exhibited by OCU410,” said Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen. “We are very enthusiastic about the potential of OCU410 as a potential one-time treatment for GA with a single sub-retinal injection. The currently approved treatments for GA target only the complement pathway and require approximately 6-12 intravitreal injections annually. OCU410 addresses multiple pathways causing dAMD, including complement, lipid metabolism, inflammation, and oxidative stress, providing long-term benefit to patients.”

The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×10¹⁰ vg/mL), medium dose (5×10¹⁰ vg/mL), and high dose (1.5 ×10¹¹ vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

About dAMD and GA
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.

About OCU410
OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in in-vitro and in-vivo (animal model) studies. These results demonstrate the ability for OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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 X 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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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 Communications
Tiffany.Hamilton@ocugen.com

Tonix Pharmaceuticals (TNXP) – Tonmya Presentations From Previous and Upcoming Trials

Posted on May 31, 2024May 31, 2024 by cpereira@noblefcm.com

Friday, May 31, 2024

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

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

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Presentations On Long COVID Trial, Upcoming PTSD Trial. Tonix presented data from its Phase 2 PREVAIL trial testing Tonmya, previously TNX 102 SL, at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The data showed improvement in symptoms that we believe support findings from Phase 3 trials in fibromyalgia. A poster presentation detailed design of an upcoming study in Acute Stress disorders after automobile accidents, expected to begin in 2Q24.

PREVIAL Data Showing Improvement In Symptoms. The study was designed as a proof-of-concept in Long COVID. Although the primary endpoint of multi-site pain reduction after 14 weeks was not met, the treatment group showed measures of effect size that met prespecified criteria for further evaluation. The study showed improvements in fatigue, sleep quality, cognition function, disability, and Patient Global Impression of Change. We believe these measures are consistent with effects seen in the Phase 3 RELIEF and RESILIENT trials.

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