Health Archives - Page 47 of 225

MustGrow Biologics Corp. (MGROF) – Releases Fiscal Year 2023 Results

Posted on April 25, 2024April 25, 2024 by cpereira@noblefcm.com

Thursday, April 25, 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.

Fiscal Year Results. Management reported revenue of CAD$4.7 million for the year from CAD$6,479 last year. This is due to fees earned from technology license, evaluation, and collaboration agreements. The Company had a net loss of CAD$676,940, or a loss of $0.01 per share, from a loss of CAD$5.6 million or $0.11 last year, with the improvement from the increased revenue.

Balance Sheet and Cash Flow. MustGrow ended the year with CAD$6.8 million in cash, slightly down from CAD$7.0 million last year. The Company used CAD$294,764 in CFFO, an improvement from a use of CAD$3.3 million last year. The improvement was due to the revenue from fees earned. Barring any additional revenue, we estimate that the Company currently has an approximate 15-month runaway before needing new capital.

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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.

Noble Capital Markets Emerging Growth Virtual Healthcare Conference Presentation Replays

Posted on April 25, 2024May 6, 2024 by slightbourne@noblecapitalmarkets.com

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**Anavex Life Sciences (AVXL)**
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**Atara Biotherapeutics, Inc (ATRA)**
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**Cadrenal Therapeutics (CVKD)**
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**Citius Pharmaceuticals Inc (CTXR)**
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**Ensysce Biosciences Inc. (ENSC)**
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**Immunic Therapeutics (IMUX)**
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**Kiora Pharmaceuticals (KPRX)**
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**Lisata Therapeutics (LSTA)**
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**MAIA Biotechnology (MAIA)**
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**SeaStar Medical Holding Corporation (ICU)**
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**SelectQuote Inc (SLQT)**
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**Tharimmune Inc (THAR)**
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**Theravance Biopharma (TBPH)**
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**Unicycive Therapeutics (UNCY)**
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**XORTX Therapeutics (XRTX)**
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**Zomedica Corp (ZOM)**
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Emerging Growth Public Healthcare Company Executive Presentations
Q&A Sessions Moderated by Noble’s Analysts and Bankers
Scheduled 1×1 Meetings with Qualified Investors

Noble Capital Markets, a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving emerging growth companies, is pleased to present the Emerging Growth Virtual Healthcare Conference, taking place April 17^th and 18^th, 2024. This virtual gathering is set to be an immersive experience, bringing together a unique blend of investors, industry leaders, and experts in the life sciences, healthcare, and medical device sectors.

Part of Noble’s Robust 2024 Events Calendar

The Emerging Growth Virtual Healthcare Conference is part of Noble’s 2024 event programming, featuring a range of c-suite interviews, in-person non-deal roadshows throughout the United States, two more sector-specific virtual equity conferences, and culminating in Noble’s preeminent in-person investor conference, NobleCon20, to be held at Florida Atlantic University in Boca Raton, Florida December 3-4. Keep an eye out for the official press release on NobleCon20 coming soon.

Check out the calendar of upcoming in-person non-deal roadshows here.

What to Expect

The Emerging Growth Virtual Healthcare Conference will feature 2 days of corporate presentations from up to 50 innovative public healthcare, biotech, and medical device companies, showcasing their latest advancements and investment opportunities. Each presentation will be followed by a fireside-style Q&A session proctored by one of Noble’s analyst or bankers, with questions taken from the audience during the presentation. Panel presentations are planned, featuring key opinion leaders in the healthcare sector, providing valuable insights on emerging trends. Scheduled one-on-one meetings with public company executives, coordinated by Noble’s dedicated Investor Outreach team, are also available to qualified investors.

Why Your Company Should Present

Looking to increase awareness in your company and increase liquidity? Paid participation in Noble’s investor conferences, both virtual and in-person, provides that opportunity, with a tailored experience aimed at delivering substantial value. After 40 years of serving emerging growth companies, and the investors who follow them, Noble has built an investor base eager to discover where the next success story lies.

Noble’s investor base is relevant and, in many cases, new to your company. Noble’s dedicated Investor Outreach team provides unmatched exposure to investors that can invest in your company, including small money managers, family offices, RIAs, wealth managers, self-directed investors, and institutions. Most of Noble’s investors specifically seek undervalued, overlooked, emerging investment opportunities.

The cost to present includes your corporate presentation with a Q&A session proctored by one of Noble’s analysts or bankers, a webcast recording, scheduled 1×1 meetings with qualified investors, and marketing on Channelchek.

Benefits for Investors

The emerging growth healthcare space may be poised for a breakout year. The recent dislocation in the healthcare and biotech spaces has created compelling valuation profiles for many companies. Hear directly from the c-suite of the next innovators in this space and learn about new investment opportunities. The Q&A portion of each presentation gives you the opportunity to have your questions answered during or after the proctored session. The planned panel presentations are sure to provide expert insight on growing trends in the healthcare space. And, for qualified investors, one-on-one meetings are available with company executives; scheduled by Noble’s dedicated Investor Outreach team. All from the comfort of your own desk, and at no cost.

How to Register

Limited presenting slots are available

Publicly traded companies in the healthcare space can submit their registration details here.

If you have any questions about presenting, please contact events@noblecapitalmarkets.com

Investor / Guest attendees can register here

Interested in becoming a sponsor of Noble’s virtual and in-person investor conferences?

Contact events@noblecapitalmarkets.com for sponsorship information.

Release – MAIA Biotechnology Announces $1.00 Million Private Placement

Posted on April 23, 2024April 23, 2024 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

April 23, 2024 8:51am EDT

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 494,096 shares of common stock at a purchase price of $2.034 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.26 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The securities being sold to the Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about April 25, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.00 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund research and development activities, such as to fund the first third of the pivotal accelerated approval Part C of the THIO-101 trial in non-small cell lung cancer (NSCLC).

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20240423249584/en/

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

Source: MAIA Biotechnology, Inc.

Released April 23, 2024

Release – PDS Biotech to Host Key Opinion Leader Event to Discuss Positive, Updated Data from Phase 2 VERSATILE-002 Clinical Trial with Versamune® HPV in Combination with KEYTRUDA® in Recurrent or Metastatic Head and Neck Cancer

Posted on April 23, 2024April 23, 2024 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Company to Host Key Opinion Leader Event on May 8 at 1:30pm ET to Discuss Updated Results of VERSATILE-002, Unmet Treatment Needs in Advanced Head and Neck Cancer and planned Triple Combination Trial

PRINCETON, N.J., April 23, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced a Key Opinion Leader (“KOL”) Event to discuss positive, updated data from its VERSATILE-002 Phase 2 clinical trial with Versamune^® HPV in combination with KEYTRUDA^® (pembrolizumab) (NCT04260126) and next steps for Versamune^® HPV and PDS01ADC. The new data cut-off from VERSATILE-002 clinical trial remains consistent with the update provided by PDS Biotech in October of 2023.

The KOL event will take place on Wednesday, May 8, 2024, at 1:30 pm ET and panel participants will include:

Dr. Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at University of North Carolina, and Principal Investigator of the VERSATILE-002 clinical trial who will present and discuss the trial results
Dr. Robert Haddad, M.D., Professor of Medicine, Harvard Medical School and Dana-Farber Cancer Institute who will discuss the unmet need in HPV-positive head and neck squamous cell cancer (“HNSCC”)

The VERSATILE-002 trial is evaluating Versamune^® HPV (formerly PDS0101) in combination with the immune checkpoint inhibitor (“ICI”) pembrolizumab in patients with unresectable, recurrent, or metastatic HPV16-positive HNSCC. The topline results to be discussed at the upcoming event are based on analysis of the most recent data cut-off.

“Approximately 20% of HPV-related patients with HNSCC will develop recurrent, incurable disease,” said Dr. Weiss. “HPV-related HNSCC that is recurrent or metastatic is a devastating, difficult-to-treat cancer, and a majority of patients do not respond to current treatments, and therefore have a relatively short survival. We believe that the data warrant further investigation in a randomized controlled clinical trial, and we are hopeful about the potential that the unique combination including Versamune^® HPV and the IL-12 fused antibody drug conjugate PDS01ADC may represent in the treatment of HPV-related HNSCC.”

To register for the Key Opinion Leader event, click here.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of IL-12 fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune^® HPV in regimen with a standard-of-care immune checkpoint inhibitor. Proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.

With a novel investigational “inside-outside” mechanism, the PDS01ADC and Versamune^® HPV immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. Robust data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated both platforms and point to potential broad utility.

Our Infectimune^® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. For more information, please visit www.pdsbiotech.com.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. 

Versamune^® and Infectimune^® are registered trademarks of PDS Biotechnology Corporation.

Keytruda^® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

Release – YS Biopharma Granted Phase I Clinical Trial License of Therapeutic Chronic Hepatitis B Virus Vaccine

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

Research News and Market Data on YS

GAITHERSBURG, Md., April 18, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (Nasdaq: YS) (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that its YS-HBV-002 immunotherapeutic vaccine, designed to treat patients suffering from chronic hepatitis B virus (“HBV”) infection, has been granted clinical trial approval by the Philippine Food and Drug Administration (“PFDA”). In light of the approval, the Company is preparing to initiate a Phase I clinical trial for YS-HBV-002 in the Philippines, which is expected to begin in June 2024.

Chronic HBV infection is a major global health concern, with an estimated 254 million people suffering from the condition, with 1.2 million new infections each year, according to the World Health Organization (WHO). Those infected are at higher risk for cirrhosis, liver failure, and liver cancer, with between 15%-40% of chronic HBV patients afflicted with one or more of these conditions. In 2022, HBV infection resulted in an estimated 1.1 million deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer). Chronic HBV infections occur in both developing and developed countries, constituting a significant unaddressed public health threat. At present, the efficacy of existing anti-viral treatment paradigms is limited, and no cure for chronic HBV has yet been developed. Despite the availability of preventive vaccines for hepatitis B infection, there remains an urgent need for effective therapies for individuals who are already infected and have progressed to chronic stages of infection.

Dr. David Shao, Director, President, and CEO of YS Biopharma, commented, “The approval of YS-HBV-002 by the Philippines FDA and Ethics Committee represents a significant milestone in our efforts to develop innovative therapies for chronic hepatitis B infection. At present, there is no effective vaccine treatment option for patients suffering from chronic HBV, leaving them at higher risk for other conditions affecting the liver and significantly hampering their quality of life. With our recent approval and upcoming clinical study, we hope to provide these patients with a safe and effective solution to combat this significant unaddressed public health threat. As always, we plan to conduct the clinical trial to the highest safety and ethical standards, and we are eager to take the next step towards delivering these much-needed treatment options to chronic HBV patients.”

The Phase I clinical trial for YS-HBV-002 will mark an important milestone in addressing this unmet medical need. This trial will employ a double-blind, randomized, placebo-controlled, dose-escalation approach, and aims to evaluate the safety, immunogenicity, and efficacy of YS-HBV-002 among adult patients diagnosed with chronic HBV infection. By targeting both humoral and cellular immune responses, YS-HBV-002 has the potential to disrupt immune tolerance mechanisms and facilitate the treatment of chronic HBV infection in patients.

About YS-HBV-002

YS-HBV-002 is a new generation of therapeutic HBV vaccine based on the proprietary technology and clinical results of YS-HBV-001, the first generation of HBV vaccine in the pipeline of YS Biopharma. YS-HBV-002 is formulated with several key components, including recombinant core and surface hepatitis B antigens, and YS Biopharma’s proprietary PIKA adjuvant. This carefully designed set of components has the potential to activate both innate and adaptive immune responses in patients, thereby generating a more robust and targeted response to the virus. The re-establishment of a desirable and comprehensive immune response is the first step towards the eradication of chronic HBV infection from the body.

About YS Biopharma

YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA^® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. YS Biopharma operates in China, the United States, Singapore and the Philippines, and is led by a management team that combines rich local expertise and global experience in the bio-pharmaceutical industry. For more information, please visit www.ysbiopharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. 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 the expected growth of YS Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, YS Biopharma’s ability to source and retain talent, and the cash position of YS Biopharma. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma’s management and are not predictions of actual performance.

YS Biopharma cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading “Risk Factors” in the Post-effective Amendment No. 2 to the Company’s Registration Statement on Form F-1 filed with the SEC on January 23, 2024, and other filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements.

Investor Relations Contact

Alyssa Li
Director of Investor Relations
Email: ir@yishengbio.com

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/ys-biopharma-granted-phase-i-clinical-trial-license-of-therapeutic-chronic-hepatitis-b-virus-vaccine-302120805.html

SOURCE YS Biopharma Co., Ltd.

Benitec Biopharma Lands $40M Lifeline to Advance Gene Therapy Pipeline

Posted on April 18, 2024April 18, 2024 by slightbourne@noblecapitalmarkets.com

In an oversubscribed private placement deal, clinical-stage biotech Benitec Biopharma (NASDAQ: BNTC) has secured $40 million in fresh capital to propel its lead gene therapy program into human trials. The financing provides an essential lifeline for the company as it aims to validate its novel “Silence and Replace” platform through clinical data readouts.

Benitec sold 5.7 million shares of its common stock at $4.80 per share, while also issuing 2.6 million pre-funded warrants in the transaction. The deal was led by healthcare investment firm Suvretta Capital Management, with participation from an investor syndicate including Adage Capital Partners, Nantahala Capital, multiple specialist healthcare funds, and a large mutual fund.

The $40 million gross proceeds dwarf Benitec’s $8.5 million cash balance exiting 2023 and strengthen the biotech’s financial runway considerably. Executives stated the capital will primarily fund development of BB-301, Benitec’s lead therapeutic candidate for Oculopharyngeal Muscular Dystrophy (OPMD).

Specifically, Benitec plans to kick off a natural history lead-in study and then initiate a Phase 1b/2a clinical trial evaluating BB-301 in OPMD patients. A portion will also support general operations as the company works to build out its pipeline leveraging the next-generation “Silence and Replace” platform.

For Benitec, scoring this level of financing commitment represents a major endorsement from the investment community. The company has been touting the promise of its dual RNA interference and gene therapy technology for years, but has leaned on equity injections and partnerships to keep the lights on.

Now, with $40 million from a blue-chip investor group, Benitec will have resources to prove its bold scientific vision can translate into real-world results for patients. Delivering clinical validation would be a game-changer in unlocking the plethora of therapeutic opportunities the “Silence and Replace” platform could potentially address.

As part of the deal terms, Benitec has agreed to consider adding Suvretta portfolio manager Kishen Mehta to its board of directors. Having greater oversight and alignment with the lead investor could tighten Benitec’s focus on prudent capital allocation and strategic execution going forward.

The financing did require issuing shares at a discount to the $4.80 prior closing price as well as warrant coverage for investors to get the deal done. But scoring that magnitude of capital from high-quality funds suggests belief in the innovative science and upcoming data milestones.

For a pre-revenue biotech still in clinical development stages, continual cash raises remain the norm. Yet this latest $40 million haul buys Benitec significant runway to produce human proof-of-concept results and hit major value-inflection points, without being forced to give away the farm through onerous dilution or a cut-rate M&A exit.

Of course, as is the case with all cutting-edge technologies, execution risk remains. Benitec and its investors are betting big on the “Silence and Replace” platform living up to its game-changing gene therapy potential. Success would be transformative, but fai lures are all too common in the high-risk, high-reward biotech realm.

With its coffers newly replenished, Benitec is approaching a make-or-break inflection point. This $40 million lifeline paves the way for the pioneering gene therapy firm to generate pivotal clinical data that could vindicate its ambitious “Silence and Replace” platform. The road ahead is unforgiving, with little margin for error against the high bar set for regulatory approval and commercial success in the cutthroat biotech sphere. But if Benitec can deliver validating evidence that its dual RNA interference and gene replacement approach translates into meaningful therapeutic benefits, it could spark a tectonic shift in how the industry tackles genetic diseases. Benitec is staring down its chance to forever change the landscape of modern medicine.

Take a moment to take a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.

Release – QuantaSing Group Accelerates Global Growth with Strategic Initiatives

Posted on April 17, 2024April 17, 2024 by cpatches

Research News and Market Data on QSG

BEIJING, April 17, 2024 (GLOBE NEWSWIRE) — QuantaSing Group Limited (NASDAQ: QSG) (“QuantaSing” or the “Company”), a leading online learning service provider in China, today announced several strategic initiatives integral to the Company’s global growth acceleration. QuantaSing is strengthening its presence in the United States and in Hong Kong as part of this plan.

The Company’s executive team, led by Tim (Dong) Xie, Chief Financial Officer of QuantaSing Group, is currently in the United States engaged in dozens of meetings with investors, potential partners and other key stakeholders in the market. These exchanges are focused on the company’s development, establishing and strengthening new and existing relationships, and shaping next steps for QuantaSing’s growth.

“Our recent visit to the United States has opened up a wealth of opportunities. We look forward to announcing new partnerships in due course,” said Tim Xie, CFO of QuantaSing. “We also anticipate the opening of our new office in Hong Kong this summer and extend a warm welcome to our friends and partners worldwide to meet us when in market.”

QuantaSing returns to the ASU + GSV Summit

QuantaSing has returned to the ASU + GSV Summit in San Diego this year as a sponsor and continues to contribute to the discussion on the future of online learning, adult education, and education technology. Ken Chau, Chief Executive Officer of Kelly’s Education (a QuantaSing company), joined a panel discussion on “Responsible AI for Kids” highlighting how Kelly’s Education and QuantaSing have harnessed AI tools to break down barriers, reduce stigma, and empower both children and elderly adults to lead more fulfilling lives.

Kelly’s Education shares key business updates

Kelly’s Education recently announced partnerships with two major authorities in English learning courses: Disney World of English and National Geographic Learning. These partnerships aim to provide children with a higher quality teaching environment and learning materials, further enhancing their learning outcomes and building Kelly’s Education as the children’s English learning platform of choice in Hong Kong.

Moreover, Kelly’s Education will announce the opening of its first offline school in May. The school will serve as an interactive, innovative learning center, offering various educational resources and high-quality teaching services, which can effectively combine the advantages of both online and traditional learning methods, providing children with an innovative and engaging learning experience.

“I am very excited to have the opportunity to engage in a discussion about the delicate dynamics of AI and children’s education,” said Ken Chau, CEO of Kelly’s Education. “During the summit, we were also able to share how we apply AI to our work to better the customer experience while guarding children’s wellbeing. Since becoming a part of the QuantaSing Group, Kelly’s Education has seen remarkable growth. Our newly established partnerships will propel us forward in our mission to establish ourselves as the premier children’s education brand in Hong Kong.”

QuantaSing to open Hong Kong office in summer

QuantaSing announces the intention to open an office in Hong Kong, the Company’s first office outside Mainland China. The new office will be situated in a prime location close to investors and business decisionmakers. With an opening planned for early-summer, the office will serve as a hub for innovation, collaboration, and further expansion into global markets. This marks an exciting new chapter in QuantaSing’s international growth journey.

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

Tel: +1 (212) 537-0429

Public Relations

Brad Burgess, Senior Vice President

ICR, LLC

Email: Brad.Burgess@icrinc.com

Small Biotech Cullinan Goes All-In on Autoimmune CAR-T in $280M Pivot

Posted on April 17, 2024April 17, 2024 by slightbourne@noblecapitalmarkets.com

In a bold strategic move, small-cap biotech Cullinan Oncology is transforming into an autoimmune disease company and rebranding as Cullinan Therapeutics. The Massachusetts company announced the major pivot alongside a $280 million private placement financing that extends its cash runway into 2028.

Cullinan is staking its future on the emerging potential of CAR-T cell therapies to treat autoimmune conditions like systemic lupus erythematosus (SLE). The company plans to advance its lead candidate CLN-978, a bispecific T cell engager originally developed for lymphoma, into SLE. An Investigational New Drug (IND) filing is targeted for the third quarter of 2024, with additional autoimmune indications likely to follow.

The strategic refocusing comes as preliminary data from small academic studies hint that CAR-T cells could induce durable remissions in autoimmune patients by depleting pathogenic B cells and modulating the immune system. In February, researchers reported that 8 out of 15 SLE patients achieved remission for over 1 year after CAR-T treatment, allowing them to discontinue all other medications.

“The unmet need in autoimmune diseases is vast, with most patients cycling through treatment after treatment without achieving remission,” said Cullinan CEO Alejandra Carvajal. “CAR-T cell therapy represents a potential paradigm shift, with an entirely novel mechanism to re-educate the immune system.”

Cullinan is one of the first movers in the autoimmune CAR-T space, but it won’t be alone for long. Peers like Kyverna, Cabaletta, Allogene and Arbor have all initiated programs or partnerships in the last year to develop similar cell therapies.

Cullinan has stopped enrolling patients in CLN-978’s lymphoma study to fully transition to autoimmune disorders. But the company is retaining its existing oncology pipeline, including lead asset zipalertinib in non-small cell lung cancer.

To fund the new autoimmune endeavors, Cullinan raised $280 million through the sale of shares and convertible securities to institutional investors. The private placement was led by venBio Partners and included Cullinan’s existing investors.

“This successful financing provides Cullinan with the resources to rapidly advance our CLN-978 program in SLE and beyond,” stated Carvajal. “We’re excited to lead the way into this new frontier at the intersection of cell therapy and autoimmune disease.”

Cullinan is making a high-risk, high-reward bet on still-unproven science. CAR-T’s efficacy in autoimmune conditions has only been explored in small patient numbers so far. But if the approach proves transformative, Cullinan could be at the vanguard of disrupting the large autoimmune drug market.

The hefty $280 million raise buys Cullinan plenty of runway to generate data from larger trials evaluating CLN-978 and shaping its future autoimmune portfolio. For autoimmune disease patients in need of new options, all eyes will be on Cullinan’s pioneering role in the promising CAR-T space.

Release – YS Biopharma to Report First Nine Months of Fiscal Year 2024 Financial Results on April 19, 2024

Posted on April 16, 2024April 16, 2024 by aweinsoff@channelchek.com

Research News and Market Data on YS

Download this Press Release

GAITHERSBURG, Md., April 16, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (NASDAQ: YS) (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it plans to release its financial results for the first nine months of the fiscal year ended March 31, 2024, before the U.S. market opens on Friday, April 19, 2024.

The Company’s management will hold an earnings conference call at 8:00 A.M. Eastern Time on Friday, April 19, 2024 to discuss the financial results. Listeners may access the call by dialing the following numbers:

United States Toll Free:	1-888-346-8982
International:	1-412-902-4272
Mainland China Toll Free:	4001-201203
Canada Toll Free:	1-855-669-9657
Hong Kong:	852-301-84992

Upon dialing-in, participants should ask to be joined into the YS Biopharma Co., Ltd. call.

The replay will be accessible through April 26, 2024 by dialing the following numbers:

United States Toll Free:	1-877-344-7529
International:	1-412-317-0088
Canada Toll Free:	1-855-669-9658
Access Code:	2468327

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

About YS Biopharma

YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. YS Biopharma operates in China, the United States, Singapore and the Philippines, and is led by a management team that combines rich local expertise and global experience in the bio-pharmaceutical industry. For more information, please visit www.ysbiopharma.com.

Investor Relations Contact

Alyssa Li
Director of Investor Relations
Email: ir@yishengbio.com

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/ys-biopharma-to-report-first-nine-months-of-fiscal-year-2024-financial-results-on-april-19-2024-302118047.html

SOURCE YS Biopharma Co., Ltd.

Eliem Bets Big on Autoimmune Pipeline with $210M Tenet Buyout

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

The biotech deal scene is heating up, with Eliem Therapeutics becoming the latest to double down on an emerging pipeline through M&A. The clinical-stage company announced it is acquiring private biotech Tenet Medicines for $120 million in stock, while simultaneously raising $120 million in a private placement to fund Tenet’s lead autoimmune disease program.

The transaction allows Eliem to pivot from its previous focus on neurological disorders to prioritize TNT119 – an anti-CD19 antibody that Tenet was developing across multiple autoimmune indications like lupus, immune thrombocytopenia, and membranous nephropathy. With $210 million in projected cash reserves after closing, the combined company plans to rapidly advance TNT119 into Phase 2 studies for systemic lupus erythematosus and immune thrombocytopenia in the second half of 2024.

“TNT119 represents a promising clinical asset across autoimmune diseases where there is a clear need for improved treatments,” said Andrew Levin, Eliem’s Executive Chairman. “This deal allows us to accelerate development of a potential best-in-class therapy while creating value for our shareholders.”

The acquisition continues the torrid pace of deal-making in biotech as companies look to revamp pipelines and build out emerging focus areas through M&A. Just in the first few months of 2024, over $30 billion in biotech acquisitions have been announced according to Bloomberg data.

Major deals included Vertex’s $4.9 billion buyout of Alpine Immune Sciences to gain a promising IgA nephropathy drug, Pfizer’s $43 billion acquisition of Seagen to bolster its oncology portfolio, and Amgen’s $27.8 billion deal for Horizon Therapeutics’ rare disease pipeline. Now Eliem is the latest to join the fray, making a significant bet on the autoimmune space.

“We believe TNT119 has best-in-class potential and could transform treatment for many autoimmune patients,” said Stephen Thomas, who will become interim CEO of the combined company after previously leading Tenet.

In addition to systemic lupus erythematosus and immune thrombocytopenia, TNT119 has also shown preliminary efficacy in treating membranous nephropathy – an autoimmune kidney disorder. By depleting B cells that produce autoantibodies driving the diseases, the therapy could provide a novel approach across this set of serious inflammatory conditions.

To fund TNT119’s ambitious development program, Eliem secured backing from a syndicate of major healthcare investors including RA Capital, Deep Track Capital, Boxer Capital and Janus Henderson in the $120 million private placement.

The wave of biotech deals has been driven by larger players looking to rebuild pipelines, while smaller companies seek resources to push programs forward amid a challenging economic environment and tight funding markets. With its Tenet acquisition, Eliem is aiming to thread that needle – gaining a promising clinical asset while raising enough capital to rapidly usher it through key studies.

For Eliem shareholders, the risky pivot to autoimmune therapies represents a major strategic shift. But if TNT119 can live up to its blockbuster aspirations, it could allow the company to go from an underdog in neurological disorders to a standout in the hot autoimmune space. That big “if” appears to be a gamble Eliem and its investors are willing to take amid biotech’s current deal-making renaissance.

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Release – Ocugen To Participate In Fireside Chat At The Emerging Growth Virtual Healthcare Equity Conference, Presented By Noble Capital Markets

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

Research News and Market Data on OCGN

April 12, 2024

MALVERN, Pa., April 12, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder will participate in a fireside chat during the Emerging Growth Virtual Healthcare Equity Conference, presented by Noble Capital Markets, taking place from April 17 – 18, 2024.

Details of the fireside chat are as follows:

Date: Wednesday, April 17, 2024

Time: 10 a.m. ET

Location: Presentation Track 1

Webcast: Available in the Events section of Ocugen website

During the fireside chat and one-on-one sessions, Dr. Musunuri will showcase the Company’s recent business and clinical development progress including FDA clearance to initiate a Phase 3 clinical trial for OCU400—a modifier gene therapy for patients battling retinitis pigmentosa (RP). OCU400 is the first gene therapy to enter a late-stage trial with a broad RP indication.

A live webcast of the fireside chat will be available in the Events section of the Company’s website and as part of a complete catalog of presentations available on Channelchek—the investor portal created by Noble. The webcast will be archived on the Company’s website for 90 days following the event.

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

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com

Cadrenal Therapeutics (CVKD) – Tecarfarin Receives Orphan Drug Designation For Second Indication

Posted on April 12, 2024April 12, 2024 by cpereira@noblefcm.com

Friday, April 12, 2024

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

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

Orphan Designation Received For Circulatory Assist Devices. Cadrenal Therapeutics has received Orphan Drug designation for tecarfarin as an anticoagulant in patients with circulatory-assist devices, including ventricular assist devices (VADs) and total artificial hearts. This is the second Orphan designation for tecarfarin. The first indication, atrial fibrillation associated with end stage renal disease (AFib with ESRD), is expected to begin a Phase 3 trial in 2Q24.

Circulatory Assist Device Patients Do Not Have Effective Anticoagulants. Mechanical devices to assist blood circulation can activate the clotting cascade, putting patients who receive them at risk of clots or thromboembolisms. Commonly used anticoagulants in the direct oral anticoagulant (DOAC) category have not shown efficacy in these patients and have been contraindicated. This leaves the patients at high risk for thromboembolic events and hospitalizations.

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

Vertex Banks on Autoimmune Therapy in $4.9 Billion Alpine Acquisition

Posted on April 11, 2024April 11, 2024 by slightbourne@noblecapitalmarkets.com

Boston-based biotech giant Vertex Pharmaceuticals announced today that it has agreed to acquire Alpine Immune Sciences for $4.9 billion in cash, placing a major bet on the smaller company’s promising drug candidate for treating serious autoimmune diseases.

The crown jewel of the acquisition is Alpine’s lead molecule povetacicept, a dual antagonist of the BAFF and APRIL proteins that have been implicated in driving several autoimmune and inflammatory conditions. Through Phase 2 trials, povetacicept has demonstrated potentially best-in-class efficacy for treating IgA nephropathy (IgAN), a serious progressive kidney disease caused by autoimmune complexes.

IgAN is the most common cause of primary glomerulonephritis (inflammation of the kidney’s filtering units) worldwide, affecting approximately 130,000 people in the U.S. alone. The disease frequently leads to end-stage renal failure, yet there are currently no approved treatments that target the underlying causes of IgAN. Povetacicept is slated to enter pivotal Phase 3 clinical trials in the second half of 2024.

“Alpine is a compelling strategic fit that furthers our ambition of creating transformative medicines for serious diseases with high unmet need,” said Reshma Kewalramani, Vertex’s CEO and President. “We look forward to bringing povetacicept, a potential best-in-class treatment for IgAN, to patients faster.”

But Vertex is betting big that povetacicept’s impact could extend far beyond just IgAN. Due to its dual mechanism targeting BAFF and APRIL, the drug candidate holds promise as a potential “pipeline-in-a-product” for treating other autoimmune diseases affecting the kidneys like membranous nephropathy and lupus nephritis. Clinical trials are also evaluating povetacicept’s utility for autoimmune cytopenias that destroy blood cells.

The $4.9 billion acquisition allows Vertex, a leader in cystic fibrosis treatments, to expand into autoimmune and inflammatory diseases – one of the hottest areas of drug development. It also provides Vertex with Alpine’s protein engineering expertise that could unlock new therapeutic modalities.

“Povetacicept has demonstrated potential best-in-class attributes and has broad development potential across autoimmune conditions with significant unmet need,” said Mitchell Gold, Alpine’s CEO. “We’re excited for the opportunity to make a meaningful difference as part of Vertex.”

The deal is structured as an all-cash tender offer, with Vertex paying $65 per share for Alpine’s outstanding stock – a substantial 92% premium over Alpine’s closing price on April 9th. Vertex expects to finance the $4.6 billion net transaction cost through a combination of existing cash on hand and new debt financing.

The acquisition, which was unanimously approved by both companies’ boards, is expected to close in the second quarter of 2024 pending regulatory approval and other customary closing conditions. It marks Vertex’s second acquisition in the autoimmune disease space in recent years, having purchased protein therapeutics firm Semma Therapeutics in 2019 for $950 million.

With povetacicept’s promising data and Vertex’s resources behind it, the combined company will be well-positioned to rapidly advance a potentially transformative new class of autoimmune therapies. But at a lofty price tag nearing $5 billion, the deal places a major bet that the Alpine drug can live up to its blockbuster aspirations.

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