Health Archives - Page 37 of 220

Release – Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering

Posted on June 13, 2024June 14, 2024 by aweinsoff@channelchek.com

June 13, 2024 5:00pm EDT

CHATHAM, N.J., June 13, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 1,199,448 shares of its common stock and pre-funded warrants to purchase up to 2,568,110 shares of common stock in a public offering at an offering price of $1.065 per share of common stock and $1.064 pre-funded warrant. The warrants have an exercise price of $0.001 per share and became exercisable upon issuance.

The gross proceeds of the offering are $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. acted as the sole placement agent for the offering.

Lowenstein Sandler, New York, NY, represented the Company in connection with the offering, and ArentFox Schiff LLP, Washington, DC, represented the placement agent.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering was made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering were filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya¹, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

¹Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. 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 including those relating to the intended use of proceeds from the public offering and other statements that are predictive in nature. 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

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

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

Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Source: Tonix Pharmaceuticals Holding Corp.

Released June 13, 2024

Release – Tonix Pharmaceuticals Announces Pricing of $4.0 Million Public Offering

Posted on June 12, 2024June 12, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 12, 2024 9:00am EDT

CHATHAM, N.J., June 12, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of 3,753,558 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $1.065 per share (or $1.064 per pre-funded warrant in lieu thereof). The closing of the public offering is expected to take place on or about June 13, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

Tonix Pharmaceuticals Holding Corp.*

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. 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 including those relating to the completion of the public offering, the satisfaction of customary closing conditions, the intended use of proceeds from the public offering and other statements that are predictive in nature. 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

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

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

Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Quantum Leap: The Next Big Investment Opportunity in Healthcare?

Posted on June 12, 2024June 12, 2024 by slightbourne@noblecapitalmarkets.com

Imagine a world where diseases are detected at the earliest stages, new life-saving drugs are developed in a fraction of the time, and medical resources are optimized to deliver the best possible care. This future may not be as far-fetched as it sounds, thanks to a revolutionary technology called quantum computing.

What is Quantum Computing?
Quantum computing is a mind-bending technology that harnesses the strange behavior of particles at the subatomic level. Unlike traditional computers that process information as binary bits (0s and 1s), quantum computers use quantum bits or qubits that can exist in multiple states simultaneously. This superposition phenomenon allows quantum computers to perform millions of calculations at once, making them exponentially more powerful than classical computers.

The Healthcare Revolution
While quantum computing may seem like something straight out of a science fiction movie, its potential applications in healthcare are very real and could transform the industry as we know it.

Accelerating Drug Discovery
One of the most promising applications of quantum computing is in the field of drug discovery. Finding new medicines is a painstakingly slow and expensive process, often taking decades and billions of dollars. Quantum computers can simulate complex molecular interactions at an unprecedented scale, allowing researchers to quickly identify promising drug candidates. This could dramatically shorten the drug development timeline, saving lives and billions of dollars.

Consider this: It takes an average of 10 years and $2.6 billion to develop a new drug from initial discovery to market approval. With quantum computing, pharmaceutical companies could potentially cut development times by years, significantly reducing costs and getting life-saving treatments to patients faster.

Personalized Medicine
We all have unique genetic makeups that influence our response to different treatments. Personalized medicine aims to tailor therapies to an individual’s genetic profile, but analyzing vast amounts of genomic data is a daunting task for classical computers. Quantum computers can process and identify patterns in complex genetic data, enabling truly personalized treatment plans that maximize efficacy and minimize side effects.

Imagine a future where your doctor can analyze your entire genome and prescribe a medication tailored specifically to your genetic makeup, minimizing the risk of adverse reactions or ineffective treatments. This level of precision could revolutionize healthcare, improving outcomes and reducing waste.

Enhanced Medical Imaging
Medical imaging techniques like MRI and CT scans generate massive amounts of data. Quantum computing can enhance image processing, improving clarity and resolution, enabling earlier detection of diseases like cancer. Early detection is key to successful treatment and could save countless lives.

With quantum-enhanced imaging, doctors could potentially identify tumors and other abnormalities at much earlier stages, significantly increasing the chances of successful treatment and survival.

Optimized Healthcare Logistics
Healthcare systems involve intricate logistics, from managing hospital resources to optimizing patient care. Quantum computing’s ability to solve complex optimization problems can help hospitals better manage staff, equipment, and patient flow, leading to improved efficiency and reduced costs.

By optimizing resource allocation and patient flow, quantum computing could help hospitals reduce wait times, improve patient experiences, and ultimately deliver better care at lower costs.

The Investment Opportunity
While quantum computing is still in its early stages, the potential payoffs in healthcare are staggering. Tech giants like IBM, Google, and startups like Rigetti Computing are investing heavily in quantum research. As the technology matures, we can expect to see a surge of investment opportunities in quantum computing companies and healthcare firms that leverage this technology.

Analysts estimate that quantum computing could create a $450 billion to $850 billion annual market by 2045, with healthcare being one of the prime beneficiaries. Early investors in this space could see massive returns as the technology takes off.

Of course, there are challenges to overcome, such as building stable, large-scale quantum computers and developing algorithms tailored for healthcare applications. However, the potential rewards are vast, both in terms of human lives saved and financial returns for savvy investors who recognize the transformative power of quantum computing in healthcare.

Quantum computing holds the promise to revolutionize healthcare by accelerating drug discovery, enabling personalized medicine, enhancing medical imaging, and optimizing resource management. While the technology is still in its early stages, the potential benefits for medicine are enormous. As we continue to explore and develop quantum computing, the future of healthcare looks brighter than ever, offering new hope for patients and medical professionals alike.

Release – Tonix Pharmaceuticals Announces Proposed Public Offering

Posted on June 11, 2024June 12, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 11, 2024 5:17pm EDT

CHATHAM, N.J., June 11, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

Tonix Pharmaceuticals Holding Corp.^*

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

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

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

Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Source: Tonix Pharmaceuticals Holding Corp.

Released June 11, 2024

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.

Release – MAIA Biotechnology Announces Year-To-Date Achievements And Highlights Recent Clinical Progress For Novel Anticancer Agent

Posted on June 6, 2024June 6, 2024 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

June 06, 2024 10:07am EDT

New science for cancer therapy drives powerful value proposition
Exceptional measures of efficacy by lead drug THIO in Phase 2 clinical trial
Funding of more than $12M year-to-date, including $7.4 million in Q2’24 so far
Secured continued insider investment through independent board members’ participation in private placement equity financings
Newest data shows THIO’s strong outperformance against standard-of-care treatments in non-small cell lung cancer (NSCLC)
38% overall response rate (ORR) in third-line (3L) setting (THIO 180mg) vs. ~6% for currently available treatments in a similar population
5.5 months median progression-free survival (PFS) (3L, THIO 180mg) more than double PFS of current chemotherapy treatments

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced Company highlights and key achievements year-to-date, including recent clinical progress for lead candidate THIO, a potential first-in-class cancer telomere targeting agent in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC).

“MAIA’s new science for cancer therapy is driving a powerful value proposition for our portfolio of novel anticancer compounds,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Our most recent clinical data points to THIO’s promising disease control, response rates, and post-therapy patient benefits. Third-line treatment with THIO has significantly outperformed reported standard-of-care data in NSCLC.

“Our confidence in the science and clinical pathways for our immuno-oncology therapies continues to grow,” Dr. Vitoc added. “This week at ASCO 2024, our poster presentation and prospects for conducting studies in various geographies has generated a wealth of positive response and excitement from U.S. and foreign oncologists and investigators about our growing cancer treatment business.”

THIO’s dual mechanism of action is designed to induce telomeric DNA damage and boost cancer-specific immune responses. The Phase 2 THIO-101 clinical trial evaluates THIO sequenced with an immune checkpoint inhibitor (CPI), cemiplimab, in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens prior to THIO dosing. MAIA successfully secured a high value clinical supply agreement for the cemiplimab used throughout the THIO-101 trial.

As of April 30, 2024, THIO-101 data from THIO 180mg + CPI in third-line treatment showed, in part:

– overall response rate (ORR) of 38%
– disease control rate (DCR) of 85%
– median progression-free survival (PFS) of 5.5 months
– median survival follow-up time of 9.1 months

“THIO works well in all doses and has an excellent safety profile, but 180mg has shown the greatest efficacy and is well tolerated compared to existing therapies. Hence, we selected 180mg per cycle as the dose going forward,” noted Dr. Vitoc. “For this heavily pre-treated population, comparative third-line data is limited. Checkpoint inhibitor resistant and platinum resistant patients are by far the largest populations with unmet medical needs in NSCLC and are also a substantial part of NSCLC cancer therapy market. We believe that our trial is providing the first real dataset in CPI-resistant patients like this. We are confident about THIO’s prospects for substantially extending patient survival and establishing a new standard of care for cancer.

“We remain steadfast in our goals for responsible access to capital. We have increased our access to cash while keeping dilution to a minimum. We plan to continue this strategy, which has shown desired outcomes so far this year while our share price has more than tripled,” added Dr. Vitoc.

MAIA reported cash and current assets of $8.7 million as of March 31, 2024. The Company’s cash position has significantly improved due to approximately $12.4 million in funds raised since February 2024 pursuant to a combination of private placements of our equity securities and sales under our at-the-market offering facility, of which approximately $7.4 million has been raised since April 1, 2024 with $6.4 million of this amount due to sales under the ATM facility to fund continuing clinical development. Our independent directors have shown continued support by investing almost $900,000 in our March and April 2024 private placements with other accredited investors.

MAIA’s Phase 2 THIO-101 clinical trial is expected to near completion in 2024. The Company is also engaged in research and development for a portfolio of second-generation THIO-like compounds.

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/20240606104003/en/

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

Source: MAIA Biotechnology, Inc.

Released June 6, 2024

Release – Tonix Pharmaceuticals Announces Two Oral Presentations and One Poster Presentation Involving TNX-1500 (Fc-modified humanized anti-CD40L mAb) at the American Transplant Congress 2024

Posted on June 6, 2024June 6, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 06, 2024 8:00am EDTDownload as PDF

TNX-1500 displays potential as a monotherapy or combination therapy to prevent rejection in organ transplantation in allograft and xenograft animal models

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital

Transplantation is also believed to be a model for treating autoimmunity

CHATHAM, N.J., June 06, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announces two oral presentations and a poster presentation at the American Transplant Congress 2024, held June 1-5, 2024 at the Pennsylvania Convention Center, Philadelphia, Pa. A copy of the oral and poster presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

“We remain encouraged by the potential of our TNX-1500, Fc-modified humanized anti-CD40L monoclonal antibody therapy for the prevention of rejection in solid organ transplantation,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Despite advancements in the field of solid organ transplantation, there remains a significant need for new treatments with improved activity and tolerability. Several lines of research indicate that anti-CD40L therapy may improve outcomes for allograft acceptance, and that anti-CD40L therapy may be required for long term xenograft acceptance. We are excited about the broad potential of TNX-1500, on the prevention of allograft and xenograft rejection and also for the treatment of autoimmune diseases like systemic lupus erythematosus and Sjögren’s Syndrome.”

In the oral presentation titled, “Combined Blockade of the CD154 and CD28 Co-Stimulation Pathways Attenuates Pathogenic Alloimmunity and Prolongs Survival in Cynomolgus Cardiac Allografts”, by Kinoshita, K. et al., data demonstrated that the combined use of TNX-1500 and anti-CD28 monoclonal antibody, VEL-101 is associated with durable protection and graft survival and function in a nonhuman primate model.

In the oral presentation titled, “Extended Survival of 9- and 10-Gene-Edited Pig Heart Xenografts with Ischemia Minimization and CD154 Costimulation Blockade-Based Immunosuppression”, Sanatkar, A. et al., data demonstrated that TNX-1500 has promise to prevent rejection of 9-, or 10-gene-edited (GE) pig hearts.^1,2

The poster presentation titled, “Experience with a Novel Delayed Immune Tolerance Protocol in Nonhuman Primates Based on Anti-CD154, Anti-CD2, and Anti-CD28”, by Ileka, I. evaluated whether a modified protocol based on targeting CD28 and CD2 promotes expansion of peripheral regulatory T-cells and is sufficient to promote heart allograft acceptance.

In February 2024, Tonix announced completion of the clinical stage of its Phase 1 single ascending dose study of TNX-1500 in healthy volunteers. The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous TNX-1500. This first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients.

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that binds and blocks the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. A first-in-human Phase 1 trial of TNX-1500 has completed the clinical phase. The primary objective of the Phase 1 trial is to assess the safety, tolerability, PK, and pharmacodynamics of intravenous (i.v.) TNX-1500. Eligible participants enrolled in the Phase 1 trial were distributed across three dosing cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg, respectively) and evaluated regularly over a 120-day period after dosing. The Phase 1 trial is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients. Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts. ^3,4

Revivicor 9-GE pigs: GalKO.β4GalNT2KO.GHRKO.hCD46.hCD55.hTBM.hEPCR.hCD47.hHO-1
Revivicor 10-GE pigs: GalKO.β4GalNT2KO.CMAHKO.GHRKO.hCD46.CD55.hTBM.hEPCR.hCD47.hHO-1.
Lassiter G., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.022
Miura S., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya¹, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace^® SymTouch^® (sumatriptan injection) 3 mg and Tosymra^® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. 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

Investor Contact

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

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

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Source: Tonix Pharmaceuticals Holding Corp.

Released June 6, 2024

MAIA Biotechnology (MAIA) – THIO-101 Data Update Shows Continued Efficacy

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.

Presentation At ASCO Updates Phase 2 THIO-101 Trial. MAIA presented data from its Phase 2 THIO-101 trial at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting. The new data includes additional patients followed for longer time periods, giving more observation points. We believe the data continues to show that THIO shows meaningful improvements over published data in several important measures of efficacy.

Third Line Treatment Shows Disease Control and Tumor Response. Patients had advanced non-small cell lung cancer (NSCLC) and were treated with the combination of THIO and cemiplimab (Libtayo, an anti-PD-1 checkpoint inhibitor from Regeneron) after failing 2 or more standard-of-care therapy regimens. The data included 20 patients who had failed two previous lines of therapy including platinum chemotherapy and checkpoint inhibitors, with a group dosed at 60 mg (n=12) and a group dosed at 180 mg (n=8). The 180 mg dose was selected as the optimal dose for further studies.

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

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

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

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