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Release – ISG Launches Next-Gen Sourcing Platform, ISG Tango™

Posted on by aweinsoff@channelchek.com

Research News and Market Data on III

3/7/2024

Solution streamlines sourcing process, expands ISG’s addressable market

STAMFORD, Conn. — Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced the launch of ISG Tango™, a groundbreaking sourcing platform that digitizes all elements of ISG’s market-leading sourcing transactions business to better serve clients, improve transaction speed and efficiency and allow ISG to expand into other market segments. 

Developed over the past year, the platform solution, available to enterprise buyers and service providers, draws on ISG’s unmatched data assets, intellectual property and proprietary tools, powered by AI to automate contracting and provide real-time predictive insights that streamline the entire transaction process and accelerate time to agreement.

“Speed, real-time transaction data, provider evaluations and other market insights are important to our clients as they navigate a more complex sourcing environment,” said Michael P. Connors, chairman and CEO of ISG. “ISG Tango delivers on all counts and strengthens our position as the industry’s sourcing advisor of choice.”

ISG is the world’s leading sourcing advisor and the industry pioneer. Working with the largest global companies (the G-2000), the firm supports more than half of advised sourcing transactions and influences more than $200 billion of global technology spend annually.

Connors said ISG Tango will allow ISG to penetrate the underserved midmarket. “We believe this platform-based offering, combined with our advisory expertise, will allow us to offer a level of sourcing advisory support that would be attractive and affordable to the midmarket, thereby expanding our revenue opportunities.”

An advisor-led solution, ISG Tango is built on an AI-supported software platform powered by ISG’s market-leading transaction data and proprietary sourcing methodology and tools. The platform features ISG’s provider research, market intelligence and candidate provider qualification system, to help enterprises make informed buying decisions, and a fully integrated service catalogue and an automated contracting tool that dramatically cuts the time and effort needed to generate contracts.

In addition, ISG Tango provides a common environment for buyers, sellers and their legal teams to work with ISG advisors on sourcing transactions. It features a secure data room with role-based authorization to manage the entire process of data collection, team interaction and contracting, efficiently and securely.

“With 24×7 access and real-time status views, ISG Tango provides full transparency throughout the entire sourcing process and simplifies interactions with all key stakeholders, leading to faster and more effective collaboration and decision-making,” said Kathy Rudy, chief data and analytics officer of ISG who co-led the development of ISG Tango.

Clay Calhoun, partner and ISG Tango market leader who co-led the development of ISG Tango, said client reception thus far has been enthusiastic. “Enterprise clients and service providers who participated in our focus groups have praised the platform for the visibility and speed to transaction it provides. To quote one client: ‘The use of the pre-populated contract documents and base case development templates was a real time saver. And the ability to model with the market pricing data helped us to accurately assess the cost, value and savings opportunity of each provider’s solution.’”

ISG Tango is available immediately. For more information, visit this webpage.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

Release – Information Services Group Announces Fourth-Quarter and Full-Year 2023 Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on III

3/7/2024

  • Reports fourth-quarter GAAP revenues of $66 million
  • Reports fourth-quarter net loss of $2.9 million, GAAP loss per share of $0.06 and adjusted EPS of $0.06; records bad-debt reserve of $4.8 million in fourth quarter for client collection risk; excluding the reserve, net income and GAAP EPS would have been $0.8 million and $0.02, respectively
  • Reports fourth-quarter adjusted EBITDA of $6 million
  • Generates $9.7 million of cash from operations in fourth quarter
  • Achieves record full-year GAAP revenues of $291 million; operating income of $15 million; net income of $6 million and GAAP EPS of $0.12; adjusted EBITDA was $38 million, adjusted net income was $20 million and adjusted EPS was $0.40
  • Launches ISG Tango™, a groundbreaking sourcing platform that improves transaction speed and efficiency, and opens new market opportunities
  • Declares first-quarter dividend of $0.045 per share, payable March 29, 2024, to shareholders of record as of March 19, 2024
  • Sets first-quarter guidance: revenues between $65 million and $67 million and adjusted EBITDA between $6.0 million and $7.0 million

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced financial results for the fourth quarter and full year ended December 31, 2023.

“ISG delivered record revenues of $291 million for the year, despite a soft fourth quarter due to slower client decision-making in an uncertain macro environment,” said Michael P. Connors, chairman and CEO. “We also delivered record recurring revenues of $125 million, up 16 percent, driven by our research business and our ISG platforms, including ISG GovernX® and ISG ProBenchmark®. Recurring revenues now represent 43 percent of our overall revenue, up 500 basis points from the prior year.

“With the overall IT and business services industry down 6 percent for the full year, we consider our topline growth of 2 percent to be solid.”

Commenting on the firm’s profitability, Connors said: “Our adjusted EBITDA margin of 13 percent for the year was held back by a fourth quarter that was negatively impacted by slower client decision-making and our decision to retain advisory talent in anticipation of an uplift later this year.”

Speaking to the demand environment for 2024, Connors said: “We expect client spending to accelerate as the year progresses, especially if, as expected, inflation continues to cool and central banks respond with interest rate cuts. Our portfolio of services, platforms, research and enterprise AI capabilities should position ISG at the center of a resurgence in technology investments this year.”

ISG Launches Next-Gen Sourcing Platform

ISG today announced the launch of ISG Tango™, a groundbreaking sourcing platform that digitizes all elements of ISG’s market-leading sourcing transactions business to better serve clients, improve transaction speed and efficiency and allow ISG to expand into other market segments.

Developed over the past year, the platform solution, available to enterprise buyers and service providers, draws on ISG’s unmatched data assets, intellectual property and proprietary tools, powered by AI to automate contracting and provide real-time insights that streamline the entire transaction process and accelerate time to agreement.

“Speed, real-time transaction data, provider evaluations and other market insights are important to our clients as they navigate a more complex sourcing environment,” said Connors. “ISG Tango delivers on all counts and strengthens our position as the industry’s sourcing advisor of choice.”

Connors said ISG Tango will also allow ISG to penetrate the underserved midmarket. “We believe this platform-based offering, combined with our advisory expertise, will allow us to offer a level of sourcing advisory support that would be attractive and affordable to the midmarket, thereby expanding our revenue opportunities.”

The launch of ISG Tango comes two months after ISG announced the launch of its new Enterprise AI Advisory business, which offers clients a suite of services to help navigate the complexities and implications of adopting artificial intelligence at scale. ISG has already won significant AI engagements with several large clients, including major companies in the banking, entertainment, manufacturing and public sectors.

Fourth-Quarter 2023 Results

Reported revenues for the fourth quarter were $66.2 million, down 11 percent from $74.2 million in the prior year. Currency translation positively impacted reported revenues by $0.7 million versus the prior year. Reported revenues were $40.1 million in the Americas, down 8 percent; $20.2 million in Europe, down 15 percent; and $5.9 million in Asia Pacific, down 12 percent, all versus the prior year.

ISG reported a fourth-quarter operating loss of $3.5 million, compared with operating income of $7.2 million the prior year. Reported fourth-quarter net loss was $2.9 million, compared with net income of $4.3 million in the prior year. Fully diluted loss per share was $0.06, compared with fully diluted earnings per share of $0.09 in the prior year.

During the fourth quarter, ISG recorded a $4.8 million reserve for amounts owed by a client. Excluding this reserve, net income and GAAP EPS would have been $0.8 million and $0.02, respectively.

Adjusted net income (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) for the fourth quarter was $3.1 million, or $0.06 per share on a fully diluted basis, compared with adjusted net income of $6.5 million, or $0.13 per share on a fully diluted basis, in the prior year’s fourth quarter.

Fourth-quarter adjusted EBITDA (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) was $5.9 million, down 47 percent from prior-year fourth quarter. Adjusted EBITDA margin (a non-GAAP measure calculated by dividing adjusted EBITDA by reported revenues) was 8.9 percent, compared with 15.0 percent in the prior year.

Full-Year 2023 Results

Reported revenues for the full-year were a record $291.1 million, up 2 percent versus the prior-year. Reported revenues were $173.2 million in the Americas, up 4 percent; $89.7 million in Europe, flat; and $28.1 million in Asia Pacific, down 5 percent, all versus the prior year.

ISG reported full-year operating income of $14.6 million, compared with $29.5 million in the prior year. The firm also reported net income and fully diluted earnings per share of $6.2 million and $0.12, respectively, versus net income of $19.7 million and earnings per share of $0.39 in the prior year. Excluding the previously mentioned reserve, net income and GAAP EPS would have been $9.8 million and $0.20, respectively.

Adjusted net income (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) for the full year was $20.1 million, or $0.40 per share on a fully diluted basis, compared with adjusted net income of $26.9 million, or $0.53 per share on a fully diluted basis, in the prior year.

Full-year adjusted EBITDA (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) was $37.7 million, down 13 percent from the prior year. Adjusted EBITDA margin (a non-GAAP measure calculated by dividing adjusted EBITDA by reported revenues) was 12.9 percent, compared with 15.1 percent in the prior year.

Other Financial and Operating Highlights

ISG generated $9.7 million of cash from operations in the fourth quarter, compared with $6.6 million in the prior year, and $12.3 million for the full year. The firm’s cash balance totaled $22.6 million at December 31, 2023, up 21 percent from $18.7 million at September 30, 2023.

During the fourth quarter, ISG paid dividends of $2.2 million and repurchased $1.7 million of shares. As of December 31, 2023, ISG had $79.2 million in debt outstanding, unchanged from the fourth quarter last year.

2024 First-Quarter Revenue and Adjusted EBITDA Guidance

“We expect an acceleration in client demand throughout the course of this year, in anticipation of an improving macro environment and increasing AI adoption. For the first quarter, ISG is targeting revenues of between $65 million and $67 million and adjusted EBITDA of between $6.0 million and $7.0 million. We will continue to monitor the macroeconomic environment, including the impact of FX, inflation and other factors, and adjust our business plans accordingly,” Connors said.

Quarterly Dividend

The ISG Board of Directors declared a first-quarter dividend of $0.045 per share, payable on March 29, 2024, to shareholders of record as of March 19, 2024.

Conference Call

ISG has scheduled a call for 9 a.m., U.S. Eastern Time, Friday, March 8, 2024, to discuss the company’s fourth-quarter results. The call can be accessed by dialing +1 (855) 761-5100; or, for international callers, by dialing +1 (646) 307-1088. The access code is 1749973. A recording of the conference call will be accessible on ISG’s website (www.isg-one.com ) for approximately four weeks following the call.

Forward-Looking Statements

This communication contains “forward-looking statements” which represent the current expectations and beliefs of management of ISG concerning future events and their potential effects. Statements contained herein including words such as “anticipate,” “believe,” “contemplate,” “plan,” “estimate,” “target,” “expect,” “intend,” “will,” “continue,” “should,” “may,” and other similar expressions, are “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of future results and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated. Those risks relate to inherent business, economic and competitive uncertainties and contingencies relating to the businesses of ISG and its subsidiaries including without limitation: (1) failure to secure new engagements or loss of important clients; (2) ability to hire and retain enough qualified employees to support operations; (3) ability to maintain or increase billing and utilization rates; (4) management of growth; (5) success of expansion internationally; (6) competition; (7) ability to move the product mix into higher margin businesses; (8) general political and social conditions such as war, political unrest and terrorism; (9) healthcare and benefit cost management; (10) ability to protect ISG and its subsidiaries’ intellectual property or data and the intellectual property or data of others; (11) currency fluctuations and exchange rate adjustments; (12) ability to successfully consummate or integrate strategic acquisitions; (13) outbreaks of diseases, including coronavirus, or similar public health threats or fear of such an event; and (14) engagements may be terminated, delayed or reduced in scope by clients. Certain of these and other applicable risks, cautionary statements and factors that could cause actual results to differ from ISG’s forward-looking statements are included in ISG’s filings with the U.S. Securities and Exchange Commission. ISG undertakes no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

Non-GAAP Financial Measures

ISG reports all financial information required in accordance with U.S. generally accepted accounting principles (GAAP). In this release, ISG has presented both GAAP financial results as well as non-GAAP information for the three and twelve months ended December 31, 2023, and December 31, 2022. ISG believes that evaluating its ongoing operating results will be enhanced if it discloses certain non-GAAP information. These non-GAAP financial measures exclude non-cash and certain other special charges that many investors believe may obscure the user’s overall understanding of ISG’s current financial performance and the Company’s prospects for the future. ISG believes that these non-GAAP measures provide useful information to investors because they improve the comparability of the financial results between periods and provide for greater transparency of key measures used to evaluate the Company’s performance.

ISG provides adjusted EBITDA (defined as net income, plus interest, taxes, depreciation and amortization, foreign currency transaction gains/losses, non-cash stock compensation, interest accretion associated with contingent consideration, tax indemnity receivables, accounts receivables reserves, acquisition-related costs, and severance, integration and other expense), adjusted net income (defined as net income, plus amortization of intangible assets, non-cash stock compensation, foreign currency transaction gains/losses, interest accretion associated with contingent consideration, acquisition-related costs, accounts receivables reserves, write-off of deferred financing cost and severance, integration and other expense on a tax-adjusted basis), adjusted net income per diluted share, adjusted EBITDA margin, and selected financial data on a constant currency basis which are non-GAAP measures that the Company believes provide useful information to both management and investors by excluding certain expenses and financial implications of foreign currency translations, which management believes are not indicative of ISG’s core operations. These non-GAAP measures are used by ISG to evaluate the Company’s business strategies and management’s performance.

We evaluate our results of operations on both an as reported and a constant currency basis. The constant currency presentation, which is a non-GAAP financial measure, excludes the impact of year-over-year fluctuations in foreign currency exchange rates. We believe providing constant currency information provides valuable supplemental information regarding our results of operations, thereby facilitating period-to-period comparisons of our business performance and is consistent with how management evaluates the Company’s performance. We calculate constant currency percentages by converting our current and prior-periods local currency financial results using the same point in time exchange rates and then compare the adjusted current and prior period results. This calculation may differ from similarly titled measures used by others and, accordingly, the constant currency presentation is not meant to be a substitution for recorded amounts presented in conformity with GAAP, nor should such amounts be considered in isolation.

Management believes this information facilitates comparison of underlying results over time. Non-GAAP financial measures, when presented, are reconciled to the most closely applicable GAAP measure. Non-GAAP measures are provided as additional information and should not be considered in isolation or as a substitute for results prepared in accordance with GAAP. A reconciliation of the forward-looking non-GAAP estimates contained herein to the corresponding GAAP measures is not being provided, due to the unreasonable efforts required to prepare it.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including AI and automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

View full release here.

Source: Information Services Group, Inc.

Release – Unicycive Therapeutics Completes Enrollment In Pivotal Clinical Trial For Oxylanthanum Carbonate (OLC)

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

March 07, 2024 4:12pm EST Download as PDF

TOPLINE DATA EXPECTED IN Q2, 2024

LOS ALTOS, Calif., March 07, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC). OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

“The completion of enrollment in our pivotal OLC clinical trial is a critical achievement for Unicycive as we strive to bring an improved therapy to chronic kidney disease patients struggling with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). We remain on track with topline data expected from the trial towards the latter part of the second quarter of this year and plan to file the NDA shortly thereafter. We want to thank the clinical trial participants, investigators, and sites whose significant interest in OLC drove strong recruitment as we pursue the goal of improving treatment options in hyperphosphatemia.”

“In this pivotal trial, we are looking to evaluate the tolerability, safety and pharmacokinetics of clinically effective doses of OLC in patients with CKD on dialysis. We believe the novel characteristics of OLC show its potential to be a best-in-class product to treat hyperphosphatemia by reducing the pill burden volume by more than 4-fold compared to the most prescribed phosphate binder. If approved, OLC will target the multibillion-dollar hyperphosphatemia market and will be a new potential therapy for physicians to administer to their patients,” added Dr. Gupta.

About the Oxylanthanum Carbonate (OLC) Pivotal Clinical Trial

The trial is expected to have 60 evaluable patients. Once participants are enrolled into the trial, they will go through a washout period for two weeks to clear their current phosphate binder from their system. Participants will initially be dosed at 500 mg of OLC three times a day (TID) and be titrated to a clinically effective dose that is defined as the dose required to achieve a serum phosphate range of ≤5.5 mg/dL. The maximum dose of OLC tested will be 3000 mg/day (1000 mg TID). As a reminder, all approved phosphate binders, including Fosrenol®, are administered on a dose titration schedule based on the control of serum phosphate. Once titrated to a clinically effective dose, participants will then be treated for four weeks to evaluate serum phosphate levels.

The primary endpoint for the trial will evaluate the tolerability of clinically effective doses of OLC in patients with CKD on dialysis. The secondary endpoints will evaluate safety and pharmacokinetics. There is no statistical analysis required to demonstrate efficacy as bioequivalence to Fosrenol was previously established; and there is no other clinical trial required to submit an NDA under the 505(b)(2) regulatory pathway.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of the number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established.

Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Source: Unicycive Therapeutics, Inc.

Released March 7, 2024

Release – Tonix Pharmaceuticals Announces Publication in Psychiatry Research Showing Activity of Bedtime TNX-102 SL on PTSD Symptoms and Sleep Quality in Military-Related PTSD at Four Weeks of Therapy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

March 07, 2024 8:00am ESTDownload as PDF

Data support evaluation of the effects of two weeks of TNX-102 SL therapy on severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and PTSD after civilian motor vehicle collision in upcoming U.S. DoD-Funded Phase 2 investigator-initiated OASIS trial

Nominal improvement in PTSD severity and measures of sleep quality at Week 4 in the HONOR study support development of bedtime TNX-102 SL therapy in the immediate aftermath of trauma

TNX-102 SL (Tonmya™) is also in late-stage development for the management of fibromyalgia for which NDA preparation is ongoing

CHATHAM, N.J., March 07, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the publication of a research paper in the Journal Psychiatry Research. The article titled, “A Phase 3, Randomized, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Military-Related Posttraumatic Stress Disorder,” by Parmenter, et al. found that bedtime TNX-102 SL* treatment is well-tolerated and showed nominal improvement in PTSD severity and sleep quality measures in the first four weeks in military-related posttraumatic stress disorder (PTSD).1 The Company believes these findings suggest a potential role for short-term bedtime TNX-102 SL treatment in the immediate aftermath of traumatic events.

The data support the U.S. Department of Defense (DoD)-funded Phase 2 investigator-initiated OASIS trial to evaluate bedtime TNX-102 SL2 in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and PTSD. The IND supporting the OASIS trial was recently cleared,3 and the trial is expected to begin enrolling in the second quarter. The trial is sponsored by The University of North Carolina Institute for Trauma Recovery and supported by a $3 million grant from DoD. In the OASIS study, 14 days of bedtime TNX-102 SL 5.6 mg will be tested in the immediate aftermath of motor vehicle collision. The study will test the potential for TNX-102 SL treatment initiated within 24 hours of index trauma to target trauma-related sleep disturbance and other ASR symptoms to facilitate recovery from ASR and to prevent PTSD.

“There is an urgent need for interventions to reduce rates of ASD and PTSD in the immediate aftermath of trauma,”4 said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe the results in the published paper suggest that bedtime TNX-102 SL has short-term activity on improving PTSD symptom severity and sleep quality in military-related PTSD. Poor sleep after trauma is a risk factor for progressing from ASD to PTSD. Therefore, poor sleep is not only a symptom of ASR, ASD and PTSD, but also a potential target of therapy.”

Dr. Gregory Sullivan, Chief Medical Officer of Tonix said, “Sleep disturbances are known to play a critical role in the development and maintenance of PTSD. The upcoming OASIS trial will test a 14-day short-course of bedtime TNX-102 SL therapy beginning within 24 hours of index trauma for effects on ASR symptoms and incidence of PTSD development. We are excited to test bedtime TNX-102 SL in the immediate aftermath of trauma to learn whether drug intervention reorients the trajectory of posttraumatic pathology from acute trauma to early recovery in the first few weeks.”

About TNX-102 SL (also known as Tonmya™ for the management of fibromyalgia)

PTSD: The Phase 3 HONOR study described in the published article was performed in military-related PTSD with the primary endpoint of improvement from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Week 12 comparing TNX-102 SL 5.6 mg and placebo. The study did not reach statistical significance on the primary endpoint.   While there was nominal improvement by the Week 4 visit on CAPS-5 (p=0.019), the improvement relative to placebo was not sustained at Weeks 8 and 12. The CAPS-5 “sleep disturbance” item also showed nominal improvement at Week 4 (p=0.002), as well as at Week 8 (p=0.026), but not thereafter. The PROMIS Sleep Disturbance T-score also showed early nominal improvement with TNX-102 SL 5.6 mg at Week 4 (p=0.015). It is also notable that when the primary endpoint was analyzed for responder rate, defined as ≥50% improvement on CAPS-5 total score at Week 4, 38.4% of those on TNX-102 SL were responders versus 24.4% on placebo (p=0.019). TNX-102 SL was well-tolerated and the adverse events reported were similar to those seen in prior TNX-102 SL studies. There were three participants with serious adverse events (SAEs) reported during the study: two in the placebo group and one in the active group. None were deemed related to study drug. Administration site reactions were similar in profile to prior studies with TNX-102 SL, with oral numbness (hypoaesthesia) at the highest rate. These oral sensory adverse events (AE), oral numbness, oral tingling, and tongue discomfort were temporally-related to dosing and were rated as mild and transient (<60 min) in the majority of cases. No new safety signals were observed.

In addition to the Phase 3 HONOR study described in the published article1, Tonix has also studied TNX-102 SL in a Phase 2 (‘AtEase’) trial in military PTSD5 and in a Phase 3 (‘RECOVERY’) trial in civilian PTSD.6 Both studies were performed with the primary endpoint of CAPS-5 improvement at Week 12. AtEase compared bedtime TNX-102 SL at two doses (2.8 mg & 5.6 mg) and placebo. RECOVERY compared TNX-102 SL 5.6 mg and placebo. Neither study reached statistical significance on the primary endpoint.  

Fibromyalgia: TNX-102 SL has shown positive results in two Phase 3 clinical trials for the management of fibromyalgia. Tonix plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of 2024 under the 505(b)(2) regulatory pathway for Tonmya for the management of fibromyalgia.

Formulation Technology and Patents: TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is designed for daily administration at bedtime with a proposed mechanism of improving sleep quality in fibromyalgia. TNX-102 SL provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic cholinergic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia. TNX-102 SL is also in development for fibromyalgia-type Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034/2035. In addition, Tonix has pending but not issued U.S. patent applications directed to the transmucosal absorption of cyclobenzaprine HCl, with U.S. market exclusivity expected until 2033, for treating depressive symptoms in fibromyalgia, with U.S. market exclusivity expected until 2032, and for treating pain in fibromyalgia with U.S. market exclusivity expected until 2041.

*TNX-102 SL has not been approved for any indication; name conditionally approved by FDA as Tonmya™ for the management of fibromyalgia

  1. Parmenter ME, et al. Psychiatry Research. 2024. 334: 115764. https://doi.org/10.1016/j.psychres.2024.115764.
  2. Tonix Press Release – September 27, 2023. “Tonix Pharmaceuticals Announces Department of Defense Grant to Support the University of North Carolina’s Proposed Investigator Sponsored OASIS Trial of TNX-102 SL for Treatment of Acute Stress Reaction, Acute Stress Disorder, and Posttraumatic Stress Disorder”. https://bit.ly/3T1LyIl
  3. Tonix Press Release – Feb 12, 2024. “Tonix Pharmaceuticals Announces FDA IND Clearance for DoD Funded Trial of TNX-102 SL for the Reduction of Acute Stress Reaction and Prevention of PTSD” https://bit.ly/3TiQOsj.
  4. Schnurr, PP et al. Annals of Internal Medicine. 2024: www.acpjournals.org/doi/10.7326/M23-2757.
  5. Sullivan GM, et al. Psychiatry Res. 2021. 301:113974. https://doi.org/10.1016/j.psychres.2021.113974.
  6. Tonix Press Release – December 21, 2020, “Tonix Pharmaceuticals Reports Topline Results from Phase 3 RECOVERY Study of TNX-102 SL in PTSD and Outlines Future Development Plans” https://bit.ly/3uOgUu8

Tonix Pharmaceuticals Holding Corp.*

Tonix is a 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 Tonmya, a product candidate for which two positive 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 with 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

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

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

Media Contact

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

Source: Tonix Pharmaceuticals Holding Corp.

Released March 7, 2024

Release – QuantaSing Announces Unaudited Financial Results for the Second Quarter of Fiscal Year 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on QSG

March 7, 2024

PDF Version

BEIJING, March 07, 2024 (GLOBE NEWSWIRE) — QuantaSing Group Limited (NASDAQ: QSG) (“QuantaSing” or the “Company”), a leading online learning service provider in China, today announced its unaudited financial results for the second quarter of the fiscal year ending June 30, 2024 (the “second quarter of FY 2024”, which refers to the quarter from October 1, 2023 to December 31, 2023).

Highlights for the Second Quarter of FY 2024

  • Revenues for the second quarter of FY 2024 were RMB980.5 million (US$138.1 million), representing an increase of 12.8% from the first quarter of the fiscal year ending June 30, 2024 (the “first quarter of FY 2024”) and an increase of 24.7% from the second quarter of the fiscal year ended June 30, 2023 (the “second quarter of FY 2023”).
  • Gross billings of individual online learning services1 for the second quarter of FY 2024 were RMB944.6 million (US$133.0 million), representing an increase of 24.0% from the first quarter of FY 2024 and an increase of 15.4% from the second quarter of FY 2023.
  • Net income for the second quarter of FY 2024 was RMB107.6 million (US$15.2 million), compared with RMB66.7 million in the first quarter of FY 2024, and a net loss of RMB41.4 million in the second quarter of FY 2023.
  • Adjusted net income2 for the second quarter of FY 2024 was RMB103.9 million (US$14.6 million), compared with RMB94.0 million in the first quarter of FY 2024, and RMB21.8 million in the second quarter of FY 2023.
  • Total registered users increased by 44.6% to approximately 112.4 million as of December 31, 2023, from 77.8 million as of December 31, 2022.
  • Paying learners increased by 24.2% year over year to approximately 0.4 million in the second quarter of FY 2024.

Mr. Peng Li, Chairman and Chief Executive Officer of QuantaSing, commented, “We are pleased to report solid topline growth for the quarter, underscoring the success of our strategic initiatives to expand and diversify our course offerings. Our focus on catering to the growing demand for senior learner courses has been particularly rewarding, and we remain committed to addressing the spiritual and cultural needs of the middle-aged and elderly population, with the goal of empowering everyone to lead fulfilling lives in their golden years. In addition to our ongoing efforts to drive revenue growth and optimize cost efficiencies, we are actively pursuing new initiatives that hold significant potential for expanding and diversifying our business. We remain steadfast in our commitment to sustaining our growth trajectory and delivering sustainable value to our shareholders.”

Mr. Dong Xie, Chief Financial Officer of QuantaSing, added, “We continued to build on our growth trajectory in the second quarter of fiscal year 2024, with total revenues increasing by 24.7% year over year and 12.8% sequentially, primarily driven by our skills upgrading courses. During the quarter, we remained committed to optimizing efficiencies and cost structures. Looking ahead, we will strengthen our core business and prudently develop new business initiatives to drive sustainable growth and deliver value to our shareholders.”

Financial Results for the Second Quarter of FY 2024

Revenues

Revenues increased by 24.7% year over year to RMB980.5 million (US$138.1 million) in the second quarter of FY 2024, primarily driven by the growth in revenues from skills upgrading courses, which primarily consist of courses aiming to improve the soft skills of individuals, such as short-video production course targets freelancers or amateurs who create video content and intend to improve their skillsets3.

  • Revenues from individual online learning services increased by 24.1% year over year to RMB873.6 million (US$123.0 million) in the second quarter of FY 2024, up from RMB704.0 million in the second quarter of FY 2023. This growth was primarily due to 1) skills upgrading courses3 increased to RMB456.4 million (US$64.3 million) in the second quarter of FY 2024 from RMB192.9 million in the second quarter of FY 2023, and 2) recreation and leisure courses3 increased to RMB96.1 million (US$13.5 million) in the second quarter of FY 2024 from RMB12.2 million in the second quarter of FY 2023, partially offset by the decrease of RMB177.9 million (US$25.1 million) in revenues from financial literacy courses.
  • Revenues from enterprise services were RMB57.6 million (US$8.1 million) in the second quarter of FY 2024, compared to RMB82.3 million in the second quarter of FY 2023, representing a year-over-year change of 30.0%, primarily due to a change in revenues from related party transactions.
  • Revenues from others increased to RMB49.3 million (US$7.0 million) in the second quarter of FY 2024 from RMB0.1 million in the second quarter of FY 2023, mainly driven by the increase in revenues from the Company’s newest business endeavor, live e-commerce, which is aligned with its commitment to diversified revenue streams.

Cost of revenues

Cost of revenues was RMB145.0 million (US$20.4 million) in the second quarter of FY 2024, compared to RMB99.3 million in the second quarter of FY 2023, representing a change of 46.1%. The increase was primarily due to increased labor outsourcing costs of RMB26.1 million (US$3.7 million) and higher procurement costs of RMB23.7 million (US$3.3 million), and was partially offset by a RMB16.5 million (US$2.3 million) decrease in staff costs.

Sales and marketing expenses

Sales and marketing expenses were RMB657.1 million (US$92.6 million) in the second quarter of FY 2024, compared to RMB622.9 million in the second quarter of FY 2023, representing a change of 5.5%. The change was mainly due to an increase in labor outsourcing costs of RMB85.3 million (US$12.0 million) and marketing and promotion expenses of RMB64.5 million (US$9.1 million), partially offset by a decrease in staff costs of RMB120.5 million (US$17.0 million), which includes a decrease in share-based compensation expenses of RMB31.0 million (US$4.4 million). The decrease in share-based compensation was primarily driven by 1) the reversal of share-based compensation expenses resulting from employee turnover during the second quarter of FY 2024, and 2) less share-based compensation expenses recognized for the second quarter of FY 2024 in accordance with the corresponding accounting treatment.

Research and development expenses

Research and development expenses were RMB41.0 million (US$5.8 million) in the second quarter of FY 2024, compared to RMB64.3 million in the second quarter of FY 2023, representing a decrease of 36.2%. The decrease was primarily due to lower share-based compensation expenses of RMB19.0 million (US$2.7 million).

General and administrative expenses

General and administrative expenses were RMB35.1 million (US$4.9 million) in the second quarter of FY 2024, compared to RMB44.5 million in the second quarter of FY 2023, representing a decrease of 21.3%. The decrease was primarily due to lower share-based compensation expenses and office expenses, partially offset by an increase in professional service fees.

Net income and adjusted net income

Net income was RMB107.6 million (US$15.2 million) in the second quarter of FY 2024, compared with a net loss of RMB41.4 million in the second quarter of FY 2023. Adjusted net income was RMB103.9 million (US$14.6 million) in the second quarter of FY 2024, compared with RMB21.8 million in the second quarter of FY 2023.

Earnings per share and adjusted earnings per share4

Basic and diluted net income per share were RMB0.65 (US$0.09) and RMB0.64 (US$0.09), respectively, in the second quarter of FY 2024, compared with basic and diluted net loss per share of RMB0.89 in the second quarter of FY 2023. Basic and diluted adjusted net income per share were RMB0.63 (US$0.09) and RMB0.62 (US$0.09), respectively, in the second quarter of FY 2024, compared with basic and diluted adjusted net income per share of RMB0.07 in the second quarter of FY 2023.

Balance Sheet

As of December 31, 2023, the Company had cash and cash equivalents and short-term investments of RMB1,050.8 million (US$148.0 million), compared with RMB930.6 million as of June 30, 2023.

Financial Outlook

Based on currently available information, for the third quarter of FY 2024 (which refers to the quarter from January 1, 2024 to March 31, 2024), the Company expects its revenues to be in the range of RMB900 million to RMB930 million, representing a year-over-year increase of 11.5% to 15.2%. The forecasts reflect the Company’s current and preliminary views on the market and its operating conditions, which are subject to change.

Recent Developments

On June 9, 2023, the Company announced that its board of directors had approved a share repurchase program of up to US$20.0 million of the Company’s Class A ordinary shares in the form of American Depositary Shares (“ADSs”) for a 12-month period beginning on June 9, 2023 (the “Share Repurchase Program”). As of December 31, 2023, the Company had accumulatively repurchased an aggregate of approximately 1.6 million ADSs for approximately US$7.8 million under the Share Repurchase Program.

On January 18, 2024, the Company announced the introduction of its first private label Chinese Baijiu brand, YUNTING. YUNTING is crafted in a core production facility located in the town of Maotai in China, a world-renowned Baijiu production site protected by Geographical Indication.

On January 22, 2024, the Company announced that Mr. Chenyang Wei was appointed as an independent director of QuantaSing and as a member of the Audit Committee.

Starting in early 2023, leveraging its cumulative insights into the adult learning sector and profound understanding of individual needs, the Company has started to explore the new e-commerce business (the “E-commerce Business”), primarily focusing on the livestreaming sales of Baijiu. Since the first quarter of FY 2024, the Company has further expanded its E-commerce Business to cover a wide range of merchandise and services catering to the demands of its users.

Since the first quarter of FY 2024, the Company has also started to explore AI and technology related business (the “AI and Technology Business”), leveraging its track record of empowering its online learning business with robust technological capabilities. The AI and Technology Business will primarily focus on the application of AI technology and other AI related area with potential business opportunities and synergies with the Company’s existing technology infrastructure and business. The Company has undertaken and will continue to undertake steps to align its corporate structure and management with the development needs of each business line and achieve management efficiency.

Conference Call Information

The Company’s management team will hold a conference call at 07:00 A.M. Eastern Time on Thursday, March 7, 2024 (08:00 P.M. Beijing Time on the same day) to discuss the financial results. Listeners may access the call by dialing the following numbers:

International:1-412-902-4272
United States Toll Free:1-888-346-8982
Mainland China Toll Free:4001-201203
Hong Kong Toll Free:800-905945
Conference ID:QuantaSing Group Limited
  

The replay will be accessible through March 14, 2024 by dialing the following numbers:

International:1-412-317-0088
United States Toll Free:1-877-344-7529
Access Code:8029802
  

A live and archived webcast of the conference call will be available at the Company’s investor relations website at https://ir.quantasing.com.

Non-GAAP Financial Measures

To supplement the Company’s consolidated financial statements, which are prepared and presented in accordance with U.S. GAAP, the Company uses gross billings of individual online learning services, adjusted net income/(loss) and basic and diluted adjusted net income/(loss) per share as its non-GAAP financial measures. Gross billings of individual online learning services for a specific period represents revenues of the Company’s individual online learning services net of the changes in deferred revenues in such period, further adjusted by value-added tax and certain cost deduction in such period. Adjusted net income/(loss) represents net (loss)/income excluding share-based compensation expense. Basic and diluted adjusted net income/(loss) per share represents adjusted net income/(loss) attributable to ordinary shareholders of QuantaSing Group Limited divided by weighted average number of ordinary shares outstanding during the periods used in computing adjusted net income/(loss) per share, basic and diluted. The Company believes that the non-GAAP financial measures provide useful information about the Company’s results of operations, enhance the overall understanding of the Company’s past performance and future prospects and allow for greater visibility with respect to key metrics used by the Company’s management in its financial and operational decision-making.

The non-GAAP financial measures are not defined under U.S. GAAP and are not presented in accordance with U.S. GAAP. The non-GAAP financial measures have limitations as analytical tools, and when assessing the Company’s operating performance, investors should not consider them in isolation, or as a substitute for revenue, net (loss)/income, net (loss)/income per share, basic and diluted or other consolidated statements of operations data prepared in accordance with U.S. GAAP. The Company’s definition of non-GAAP financial measures may differ from those of industry peers and may not be comparable with their non-GAAP financial measures.

The Company mitigates these limitations by reconciling the non-GAAP financial measures to the most comparable U.S. GAAP performance measures, all of which should be considered when evaluating the Company’s performance. For more information on these non-GAAP financial measures, please see the table captioned “QuantaSing Group Limited Unaudited Reconciliation of GAAP and Non-GAAP Results” near the end of this release.

Exchange Rate Information

This announcement contains translations of certain Renminbi (“RMB”) amounts into U.S. dollars (“US$”) at specified rates solely for the convenience of the reader. Unless otherwise stated, all translations from Renminbi to U.S. dollars were made at the rate of RMB7.0999 to US$1.00, the exchange rate on December 29, 2023, set forth in the H.10 statistical release of the Federal Reserve Board. The Company makes no representation that the Renminbi or U.S. dollars amounts referred to could be converted into U.S. dollars or Renminbi, as the case may be, at any particular rate or at all.

Safe Harbor Statements

This announcement contains forward-looking statements within the meaning of Section 27A of Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended and the Private Securities Litigation Reform Act of 1955. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding QuantaSing’s financial outlook, beliefs and expectations. These statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets,” “guidance” and similar statements. Among other things, the Financial Outlook in this announcement contains forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases, and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the Company’s growth strategies; its future business development, results of operations and financial condition; its ability to attract and retain new users and learners and to increase the spending and revenues generated from users and learners; its ability to maintain and enhance the recognition and reputation of its brand; its expectations regarding demand for and market acceptance of its services and products; trends and competition in China’s adult learning market; changes in its revenues and certain cost or expense items; the expected growth of China’s adult learning market; PRC governmental policies and regulations relating to the Company’s business and industry, general economic and political conditions in China and globally, and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks, uncertainties, or factors is included in the Company’s filings with the SEC, including, without limitation, the final prospectus related to the IPO filed with the SEC dated January 24, 2023. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

About QuantaSing Group Limited

QuantaSing is a leading online service provider in China dedicated to improving people’s quality of life and well-being by providing lifelong personal learning and development opportunities. The Company is the largest service provider in China’s online adult learning market and China’s adult personal interest learning market in terms of revenue, according to a report by Frost & Sullivan based on data from 2022. By leveraging its proprietary tools and technology, QuantaSing offers easy-to-understand, affordable, and accessible online courses to adult learners, empowering users to pursue personal development. Leveraging its extensive experience in individual online learning services and its robust technology infrastructure, the Company has expanded its services to corporate clients, and diversified its operations into its e-commerce business and its AI and technology business.

For more information, please visit: https://ir.quantasing.com.

Contact

Investor Relations
Leah Guo
QuantaSing Group Limited
Email: ir@quantasing.com 
Tel: +86 (10) 6493-7857

Robin Yang, Partner
ICR, LLC
Email: QuantaSing.IR@icrinc.com 
Phone: +1 (212) 537-0429

_________________________________

1 Gross billings of individual online learning services is a non-GAAP financial measure. For a reconciliation of revenues of individual online learning services to gross billings of individual online learning services, see the “Non-GAAP Financial Measures” section and the table captioned “QuantaSing Group Limited Unaudited Reconciliation of GAAP and Non-GAAP Results” below.
2 Adjusted net income/(loss) is a non-GAAP financial measure. For a reconciliation of net (loss)/income to adjusted net income/(loss), see the “Non-GAAP Financial Measures” section and the table captioned “QuantaSing Group Limited Unaudited Reconciliation of GAAP and Non-GAAP Results” below.
3 The Company has introduced a new presentation of its revenues, which split other personal interest courses into skills upgrading courses and recreation and leisure courses, to better align with its business strategies and provide useful and updated information to investors. Skills upgrading courses mainly include short-video production courses and memory training courses. Recreation and leisure courses mainly include personal well-being courses, electronic keyboard courses and standing meditation courses. The historical revenues presentation has been conformed to the current presentation.
4 Basic and diluted adjusted net income/(loss) per share are non-GAAP financial measures. For a reconciliation of basic and diluted net (loss)/income per share to basic and diluted adjusted net income/(loss) per share, see the “Non-GAAP Financial Measures” section and the table captioned “QuantaSing Group Limited Unaudited Reconciliation of GAAP and Non-GAAP Results” below.

View full release here.

Orion Group Holdings (ORN) – Some Insider Buying

Posted on by cpereira@noblefcm.com


Thursday, March 07, 2024

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Insider Buying. Two Orion executives-CEO Travis Boone and General Counsel Chip Earle-added to their Orion holdings following the February 28th release of full year results. We would note Orion shares fell on the earnings news, dropping as low as $5.81 after closing the prior day at $6.92. While the purchases were modest, the acquisition of shares on the heels of the price drop is informative, in our view.

Travis Boone. On March 4th, CEO Travis Boone reported the purchase of 12,000 ORN shares at an average cost of $7.01 per share. The shares were acquired at prices ranging from $6.91-$7.08. The recent purchase increased Mr. Boone’s overall Orion stake to 402,557 shares. Notably, this appears to be the first open market purchases made by Mr. Boone.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

MAIA Biotechnology (MAIA) – New THIO-101 Update Shows Consistent Overall Response Rate

Posted on by cpereira@noblefcm.com


Thursday, March 07, 2024

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

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

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

Third Line Patients’ Preliminary Overall Response Rate (ORR) Shows Improvement. MAIA announced updated data from its THIO-101 trial. The trial enrolled patients with Stage 3 or 4 NSCLC who have progressive disease after treatment with checkpoint inhibitor therapy with or without standard of care chemotherapy. These advanced disease patients were treated with the combination of THIO and Libtayo (cemiplimab, an anti-PD-1 checkpoint inhibitor from Regeneron). The data was from the first patients receiving treatment as third-line therapy that reached an evaluation timepoint by January 8, 2024.

ORR Greatly Exceeded Published Studies. New data was from patients who had received the THIO combination as third-line treatment. The overall response rate was 38%, with 3 out of 8 patients showing a complete response (CR) or partial response (PR). This compares with response rates of about 6% in published studies.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

GeoVax Labs (GOVX) – Vaccine Production Technology Reaches Milestone With Manufacturing Facility Validation

Posted on by cpereira@noblefcm.com


Thursday, March 07, 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.

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

Commercial Scale Production Facility Achieves Validation. GeoVax has announced that its manufacturing technology for producing commercial-scale MVA-based vaccines has been validated for production. This signifies the successful transfer of the technology from the research facility to the commercial cGMP manufacturing plant, with production runs that meet specifications for use in clinical trials and commercial sales. This was a milestone we had anticipated that allows higher quantities, faster production, and greater yields of its proprietary MVA-based vaccines.

The New Manufacturing Facility Cam Produce The Pipeline Vaccines. Products that can be made in the system include CM04S1, its vaccine currently in two different Phase 2 trials to stimulate protective responses against COVID for immunocompromised patients with hematological cancers and in Phase 2 as a universal booster for COVID. The facility can also produce the vaccines in development for infectious diseases including smallpox, Ebola, zika, and malaria.


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*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. 

Commercial Vehicle Group (CVGI) – Fourth Quarter Post Call Commentary

Posted on by cpereira@noblefcm.com


Thursday, March 07, 2024

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Impact of UAW Strike on 4Q. Fourth quarter results were negatively impacted by a work stoppage at a customer facility due to the UAW strike. Management estimated the strike reduced revenue by about $12 million and had a $0.05/sh negative impact on EPS. We expect that eventually the revenue will come back, it is just a question of timing.

New Wins. CVG recorded in excess of $150 million of new wins in 2023 on a fully ramped basis, continuing the Company’s strong track record of success. The wins continue to be focused within the Electrical Systems segment and support the product ramp-up at the new plants in Mexico and Morocco, which are focused on meeting the demand growth in electrical systems. CVG is currently expanding its Morocco footprint with an additional new plant under construction.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

AI in Healthcare: The Next Frontier for Investors?

Posted on by slightbourne@noblecapitalmarkets.com

In the ever-evolving world of technology, few terms have captured the imagination of investors quite like artificial intelligence (AI). From autonomous vehicles to virtual assistants, AI has permeated nearly every facet of modern life, disrupting traditional business models and creating new opportunities for growth and innovation.

One sector that is increasingly feeling the transformative impact of AI is healthcare. As the industry grapples with challenges such as rising costs, workforce shortages, and the need for more personalized and efficient care, AI is emerging as a powerful tool to address these issues and unlock new frontiers in medicine.

The applications of AI in healthcare are vast and varied, ranging from drug discovery and disease diagnosis to patient monitoring and virtual nursing assistants. At the forefront of this revolution are companies that are harnessing the power of AI to develop cutting-edge solutions and drive technological advancements in the field.

One area where AI is making significant strides is medical imaging and diagnostics. Companies like Enlitic, a pioneer in deep learning for radiology, are developing AI systems that can analyze medical images with unprecedented accuracy, aiding in the early detection of diseases and reducing the risk of misdiagnosis. By automating and enhancing the analysis of X-rays, CT scans, and MRI images, these AI solutions have the potential to improve patient outcomes while reducing the workload on healthcare professionals.

Another promising application of AI in healthcare is drug discovery and development. Traditionally, the process of bringing a new drug to market has been time-consuming and costly, often taking years and billions of dollars in research and clinical trials. However, AI is revolutionizing this process by analyzing vast amounts of data, identifying promising drug candidates, and accelerating the drug discovery pipeline.

Companies are leveraging machine learning algorithms to search through millions of potential drug compounds, predicting their efficacy and safety profiles with remarkable accuracy. This not only speeds up the drug development process but also increases the likelihood of successful clinical trials and faster time-to-market for new therapies.

Beyond drug discovery and medical imaging, AI is also playing a crucial role in personalized medicine and patient care. Companies are developing AI-powered virtual healthcare assistants that can provide personalized medical advice, triage patients, and even monitor chronic conditions remotely. By leveraging natural language processing and machine learning, these AI solutions can offer accessible and affordable healthcare services, particularly in underserved or remote areas.

For investors, the proliferation of AI in healthcare presents both opportunities and challenges. On the one hand, the potential for groundbreaking innovations and disruptive technologies in this sector could translate into significant returns for those who identify and invest in the right companies early on. However, the healthcare industry is also heavily regulated, and navigating the complex web of regulatory approvals and clinical trials can be a significant hurdle for AI-driven healthcare solutions.

Furthermore, as with any emerging technology, there are ethical considerations and potential risks associated with the use of AI in healthcare. Concerns around data privacy, algorithmic bias, and the potential for AI to perpetuate or exacerbate existing healthcare disparities must be carefully addressed to ensure the responsible and equitable deployment of these technologies.

Despite these challenges, the investment community is eagerly watching the AI healthcare space, recognizing the immense potential for transformative innovations and lucrative returns. As the adoption of AI in healthcare continues to accelerate, companies that can successfully navigate the regulatory landscape, mitigate risks, and deliver tangible solutions that improve patient outcomes and healthcare efficiency are likely to emerge as leaders in this burgeoning field.

For savvy investors, the key to capitalizing on the AI healthcare revolution lies in conducting thorough due diligence, understanding the competitive landscape, and identifying companies with robust AI capabilities, strong intellectual property portfolios, and a clear path to commercialization and scalability.

While AI may be a buzzword that often moves markets, in the healthcare sector, it represents a genuine paradigm shift with the potential to save lives, reduce costs, and transform the way we approach healthcare delivery. As such, investors who can separate the hype from the reality and identify the true pioneers in this space may be well-positioned to reap the rewards of this technological revolution.

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Mortgage Rates and Stocks Find Relief as Powell Reinforces Rate Cut Prospects

Posted on by slightbourne@noblecapitalmarkets.com

The housing and stock markets received a welcome boost this week as Federal Reserve Chair Jerome Powell reinforced expectations for interest rate cuts later this year. In his semi-annual monetary policy testimony to Congress, Powell acknowledged that recent data shows inflation is moderating, paving the way for potential rate reductions in 2024.

For homebuyers and prospective sellers who have grappled with soaring mortgage rates over the past year, Powell’s remarks offer a glimmer of hope. Mortgage rates, which are closely tied to the Fed’s benchmark rate, have retreated from their recent highs, dipping below 7% for the first time since mid-February.

According to Mortgage News Daily, the average rate for a 30-year fixed-rate mortgage settled at 6.92% on Thursday, while Freddie Mac reported a weekly average of 6.88% for the same loan term. This marks the first contraction in over a month and a significant improvement from the peak of around 7.3% reached in late 2023.

The moderation in mortgage rates has already begun to revive homebuyer demand, as evidenced by a nearly 10% week-over-week increase in mortgage applications. The Mortgage Bankers Association (MBA) noted that the indicator measuring home purchase applications rose 11%, underscoring the sensitivity of first-time and entry-level homebuyers to even modest rate changes.

“Mortgage applications were up considerably relative to the prior week, which included the President’s Day holiday. Of note, purchase volume — particularly for FHA loans — was up strongly, again showing how sensitive the first-time homebuyer segment is to relatively small changes in the direction of rates,” said Mike Fratantoni, MBA’s chief economist.

This renewed interest from buyers coincides with a much-needed increase in housing inventory. According to Realtor.com, active home listings grew 14.8% year-over-year in February, the fourth consecutive month of annual gains. Crucially, the share of affordable homes priced between $200,000 and $350,000 increased by nearly 21% compared to last year, potentially opening doors for many previously priced-out buyers.

The stock market has also responded positively to Powell’s testimony, interpreting his comments as a reassurance that the central bank remains committed to taming inflation without derailing the economy. Despite a hotter-than-expected inflation report in January, Powell reiterated that rate cuts are likely at some point in 2024, provided that price pressures continue to subside.

Investors cheered this stance, propelling the S&P 500 to new record highs on Thursday. The benchmark index gained nearly 1%, while the tech-heavy Nasdaq Composite surged 1.4%, underscoring the market’s preference for a more dovish monetary policy stance.

However, Powell cautioned that the timing and magnitude of rate cuts remain uncertain, as the Fed seeks to strike a delicate balance between containing inflation and supporting economic growth. “Pinpointing the optimal timing for such a shift has been a challenge,” said Jiayi Xu, Realtor.com’s economist. “Specifically, the risk of a dangerous inflation rebound is looming if rate cuts are made ‘too soon or too much.'”

This ambiguity has contributed to ongoing volatility in both the housing and stock markets, as market participants attempt to gauge the Fed’s next moves. While the prospect of rate cuts has provided relief, concerns remain that the central bank may need to maintain a more hawkish stance if inflationary pressures prove more stubborn than anticipated.

Nevertheless, Powell’s remarks have injected a sense of optimism into the markets, at least temporarily. For homebuyers, the potential for lower mortgage rates could translate to increased affordability and a more favorable environment for purchasing a home. Meanwhile, investors have embraced the possibility of a less aggressive monetary policy stance, driving stocks higher in anticipation of a potential economic soft landing.

As the data continues to unfold, both the housing and stock markets will closely monitor the Fed’s actions and rhetoric. While challenges persist, Powell’s testimony has offered a glimpse of light at the end of the tunnel, reigniting hopes for a more balanced and sustainable economic landscape in the months ahead.

Release – GeoVax Achieves Milestone in Transition to Commercially Validated Manufacturing System

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

Manufacturing Process for Phase 3 and Commercial Production

Being Developed for GeoVax MVA-Based Vaccines

Atlanta, GA, March 6, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced a significant milestone toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for the company’s MVA-based vaccines, with the release of its first lot of GEO-CM04S1 (next-generation Covid-19 vaccine) produced with a commercial manufacturing platform. This milestone marks the successful completion of the transfer and scale-up of manufacturing from the research-focused Center for Biomedicine & Genetics at City of Hope (Duarte, CA) to the experienced CDMO ABL Europe (a subsidiary of Oxford Biomedica), the Company’s cGMP (current Good Manufacturing Procedures) manufacturing partner.

David Dodd, GeoVax President and CEO, commented, “The successful establishment of cGMP production at ABL Europe represents great progress for GeoVax and the CM04S1 program. This latest manufacturing milestone also validates our choice of ABL Europe as our partner for cGMP production of our MVA-based vaccine candidates. This gives us a high degree of confidence in our manufacturing process as we move into late-stage clinical development for CM04S1, addressing a critically important unmet medical need for immunocompromised populations.”

Dodd continued, “While we continue the use of CEF-based production for our CM04S1 clinical programs, it is important to also recognize the significant advancements made in our commercial-scale production capabilities. Our multi-product license of ProBioGen’s AGE1.CR.PIX® suspension cell line enhances our capacity to produce MVA-based vaccines (including CM04S1 and GEO-MVA) and immunotherapies at an unprecedented scale. These developments signify GeoVax’s commitment to improving vaccine accessibility through cost-effective and scalable manufacturing processes.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation Covid-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the continually emerging variants of Covid-19. Results released during 2023 demonstrated the safety and efficacy of CM04S1 and emphasize the role it will play in protecting immunocompromised patients from greater risk of severe disease, hospitalization and death from SARS-CoV-2 infection.

About GEO-MVA

In response to the global need to address the continued emerging threat from Mpox (monkeypox), GeoVax previously announced having secured rights from the National Institutes of Health (NIH) covering preclinical, clinical and commercial uses of the NIH-MVA as a vaccine against Mpox or smallpox.  The Company is currently pursuing different regulatory pathways toward achievement of an expedited approval and intends to become the first U.S.-based supplier of the MVA vaccine to prevent Mpox and smallpox.

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®, 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. 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 paige.kelly@sternir.com sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Release – MAIA Biotechnology Announces Strong Efficacy of THIO As Third-Line Treatment For Non-Small Cell Lung Cancer Patients

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

 

March 06, 2024 8:48am EST

  • Combination THIO 180mg + cemiplimab achieved 38% overall response rate (ORR) in difficult-to-treat, third-line non-small cell lung cancer (NSCLC)
  • ORR of 38% significantly exceeds standard of care ORR in NSCLC third-line in patients without a targetable mutation who progressed on checkpoint inhibitors and chemotherapy

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive efficacy data for third-line treatment in its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC).

As of January 8, 2024, overall response rate (ORR), characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for combination THIO 180mg + cemiplimab in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy.

“As an impressive measure of efficacy, the strong response rate of 38% in third-line treatment supports our premise that THIO administration prior to cemiplimab can improve tumor responses to immunotherapy in advanced NSCLC patients resistant to CPIs and other standard treatments,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Around 60-70% of NSCLC patients do not have a targetable mutation and cannot benefit from a biomarker-targeted therapy, making it the greatest unmet medical need population in lung cancer. In currently available treatments for these patients in third-line, response rates range around 6%.1 We are encouraged by the excellent efficacy findings in THIO-101 to date, adding impressive ORR to unprecented disease control rates (DCR), and further demonstrating the potential of our first-in-class treatment to redefine the standard of care for NSCLC patients.”

The efficacy evaluable population defined in the THIO-101 protocol considers all subjects who received at least one dose of THIO treatment and have at least one postbaseline tumor assessment (scans). Two third-line patients in the 180mg dose cohort did not have recorded scans at the data cutoff. Safety remained consistent with previous reports.

The Company recently announced early completion of enrollment in the THIO-101 trial. THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment.

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.

1 Journal of Thoracic Oncology, Volume 4, Number 12, December 2009. *Note: no updated 3rd line NSCLC data in recent years.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240306359543/en/

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

Source: MAIA Biotechnology, Inc.

Released March 6, 2024