Smart Immune and CELLforCURE by SEQENS Partner to Industrialize SMART101 Clinical Batches Manufacturing




Smart Immune and CELLforCURE by SEQENS Partner to Industrialize SMART101 Clinical Batches Manufacturing

PRESS RELEASE | Paris, France – December 3, 2024

Smart Immune, a clinical-stage biotechnology company, and CELLforCURE by SEQENS, a Contract Development and Manufacturing Organization (CDMO) for Advanced Therapy Medical Products (ATMPs), announced today a strategic collaboration to expand SMART101 production capabilities. SMART101 is an innovative therapy in Phase I/II trials for patients with acute leukemia or primary immunodeficiencies (PID), in the EU and the US.

Enhanced Production Capacity

This partnership will complement Smart Immune’s existing capabilities at the MEARY Center for Cell and Gene Therapy and Necker Children Hospital in Paris, supporting the company’s expanding clinical development with patients’ inclusions expected to rapidly increase in 2025.
The collaboration will enable the production of SMART101 for the ReSET trials in primary immune deficiencies and hematological malignancies post-transplant, as well as for new proof-of-concept trials in solid tumors. CELLforCURE brings a robust and strongly established commercial manufacturing experience, positioning itself as a highly reliable partner for Smart Immune at a critical development stage of its ProTcell platform.

Manufacturing Process Evolution

As part of this collaboration, the technology transfer will involve an intermediate manufacturing process, currently being set up at the MEARY Centre, which will bridge the gap between current clinical production methods and future fully automated steps.

This evolution includes cell selection, scale-up aligned with future v2.0 requirements, and semi-automation of key steps like the implementation of mini-bioreactor-based production.

Accelerating Patient Access

“This collaboration marks a significant step in our mission to bring innovative cell therapies to more patients,” says Karine Rossignol, Co-Founder and Chief Executive Officer of Smart Immune. “By partnering with CELLforCURE, we’re establishing a robust manufacturing framework to support our growing clinical programs and future commercialization needs.”

“We are very proud to collaborate with Smart Immune and contribute to the ambition of bringing innovative cell therapies to more patients,” says Pierre-Noël Lirsac, President of CELLforCURE. “CELLforCURE will leverage its historical expertise as a CDMO as well as its “real-life” experience to manufacture SMART101 clinical batches.”

Pierre Heimendinger, Chief Technical Officer of Smart Immune, adds: “The enhanced manufacturing process, featuring rapid sterility testing, will enable a vein-to-vein time of just two weeks. This is particularly crucial for patients receiving fresh allogeneic hematopoietic stem cell transplants within the European and Middle Eastern zones.”

Strategic Choice of European Manufacturing

The choice of CELLforCURE, with its established track record in commercial cell therapy manufacturing, aligns with Smart Immune’s commitment to maintaining production excellence in France and Europe. This decision builds upon the foundation established with the MEARY Center at Saint-Louis Hospital and Necker Children Hospital, reflecting the company’s dedication to leveraging French and European expertise in advanced therapy manufacturing.

A commitment also shared by the SEQENS Group, who capitalized and invested in France and Europe to maintain and develop essential and strategic capabilities for the healthcare sector.

About CELLforCURE and SEQENS:

CELLforCURE SAS (commercial name: CELLforCURE by SEQENS) is a CDMO authorized by ANSM, dedicated to ATMPs production from concept to commercialization. With advanced technologies, extensive capabilities, and large scale capacity, CELLforCURE offers a seamless journey from early-stage development to commercial manufacturing of a wide range of cell therapies.

CELLforCURE is part of the SEQENS Group, a global partner in health, personal care and specialty ingredients, leveraging 3300 employees, 16 manufacturing sites and 9 R&D centers in 9 countries.

press@seqens.com / www.seqens.com / LinkedIn: SEQENS and CELLforCURE by SEQENS

About Smart Immune:

Smart Immune is a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T-cell progenitor platform to rapidly re-arm the immune system against cancer and infection. The company aims to radically improve outcomes for patients in hematology and immuno-oncology. Its main asset SMART101 is in Phase I/II trials for patients with acute leukemia or primary immunodeficiencies (PID), in the EU and the US. Additional clinical applications are planned to be evaluated in combination with innovative cancer therapies.

lwormser@ulysse-communication.com (+33) 06 13 12 04 04 /  www.smart-immune.com / LinkedIn: Smart Immune

Jupiter Neurosciences, Inc. Announces Pricing of $11 million Initial Public Offering and Listing on Nasdaq




Jupiter Neurosciences, Inc. Announces Pricing of $11 million Initial Public Offering and Listing on Nasdaq

Jupiter, Florida, Dec. 02, 2024 (GLOBE NEWSWIRE) — Jupiter Neurosciences, Inc. (Nasdaq: JUNS) (the “Company” or “Jupiter Neurosciences”), a clinical stage pharmaceutical company advancing a pipeline targeting neuroinflammation with its unique resveratrol platform product, JOTROL^™, today announced the pricing of its initial public offering (the “Offering”) of 2,750,000 shares of common stock at a price of $4.00 per share.

The shares are expected to begin trading on the Nasdaq Capital Market on December 3, 2024 under the symbol “JUNS.” The Offering is expected to close on December 4, 2024, subject to the satisfaction of customary closing conditions.

The Company expects to receive aggregate gross proceeds of $11 million from the Offering, before deducting underwriting discounts and other related expenses.

The Company intends to use the net proceeds from the Offering to fund the Phase II clinical trial of its product candidate JOTROL^™ in patients with Parkinson’s Disease, Strategic Service Agreements to accelerate business activities in South-East Asia, research and development activities regarding evaluation of new product opportunities, payment of the outstanding annual license fees due to Aquanova AG, the repayment of debt, working capital and other general corporate purposes.

The Offering is conducted on a firm commitment basis. Dominari Securities LLC is acting as the lead underwriter, with Revere Securities LLC acting as the co-manager (collectively, the “Underwriters”) for the Offering. 

Anthony, Linder & Cacomanolis, PLLC is acting as legal counsel to Jupiter Neurosciences and ArentFox Schiff LLP is acting as legal counsel to the Underwriters in connection with the Offering.

The Company’s Registration Statement on Form S-1 (File No. 333- 260183) relating to the securities being offered was previously filed with, and subsequently declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on November 8, 2024. The Offering is being made only by means of a prospectus. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the prospectus relating to the Offering may be obtained, when available, from Dominari Securities LLC by email at info@dominarisecurities.com, by standard mail to Dominari Securities LLC, 725 Fifth Avenue, 23rd Floor New York, NY 10022, or by telephone at (212) 393-4500; or from Revere Securities LLC by email at contact@reveresecurities.com, by standard mail to Revere Securities LLC, 560 Lexington Avenue, 16th Floor, New York, NY 10022, or by telephone at +1 (212) 688-2350.

Before you invest, you should read the prospectus and other documents the Company has filed or will file with the SEC for more information about the Company and the Offering. This press release has been prepared for informational purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, and no sale of these securities may be made in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

About Jupiter Neurosciences, Inc.

Jupiter Neurosciences, Inc. is a clinical-stage pharmaceutical company focused on treating neuroinflammation, with a current focus on CNS disorders and rare diseases. The Company’s platform product, JOTROL^™, is an enhanced orally administered resveratrol formulation designed and intended to deliver therapeutically relevant, safe levels of resveratrol. The Company’s pipeline is focused broadly on CNS disorder and includes indications such as Alzheimer’s Disease, Parkinson’s Disease, Mucopolysaccharidoses Type 1, Friedreich’s Ataxia, and MELAS. More information may be found on the Company’s website www.jupiterneurosciences.com.

FORWARD-LOOKING STATEMENTS

Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations, including the timing of the trading of its common stock or the closing of the Offering. Investors can find many (but not all) of these statements by the use of words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct. The Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to read the risk factors contained in the Company’s final prospectus and other reports it files with the SEC before making any investment decisions regarding the Company’s securities. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.

Contacts

Investor Relations
Alison Silva, President & CBO
a.silva@jupiterneurosciences.com

Rakovina Therapeutics Increases Private Placement Offering to $3.0 Million




Rakovina Therapeutics Increases Private Placement Offering to $3.0 Million

VANCOUVER, British Columbia, Dec. 02, 2024 (GLOBE NEWSWIRE) — Rakovina Therapeutics Inc. (TSX-V: RKV, the “Company” or “Rakovina Therapeutics”) a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies is pleased to announce that its previously announced private placement has been further upsized up to $3 million, based on strong indications of interest from potential investors in the financing.

The Offering is structured as units priced at $0.06 each, with each unit consisting of one common share and one warrant to purchase a common share. Each warrant entitles the holder to purchase one additional common share at a price of $0.10 per share, exercisable for a period of 24 months. Rakovina retains the right to accelerate the warrant exercise period if the 20-day volume-weighted average price of its shares exceeds $0.30.

The Company plans to use the proceeds to continue the discovery and advancement of novel cancer treatments by leveraging collaborations with two proprietary Artificial Intelligence (AI) platforms: the Deep Docking™ AI platform and the Variational AI Enki™ Platform. The Company also plans to continue the development of its kt-3000 series through collaborations and partnerships with biotech and pharma companies.

The Offering is subject to all necessary regulatory approvals including acceptance from the TSX Venture Exchange. The Units will be sold on a non-brokered “private placement” basis in accordance with applicable Canadian securities laws and under applicable exemptions from prospectus and registration requirements and the securities will be subject to resale restrictions for a period of four months plus one day from the date of issue.

About Rakovina Therapeutics Inc.

Rakovina Therapeutics Inc. is focused on the development of new cancer treatments based on novel DNA-damage response technologies. The Company has established a pipeline of novel DNA-damage response inhibitors with the goal of advancing one or more drug candidates into human clinical trials and obtaining marketing approval for new cancer therapeutics from Health Canada, the United States Food and Drug Administration and similar international regulatory agencies. Further information may be found at www.rakovinatherapeutics.com.

The TSXV has neither approved nor disapproved the content of this press release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

Notice Regarding Forward-Looking Statements:

This release includes forward-looking statements regarding the Company and its respective business, which may include, but is not limited to, statements with respect to the terms of the private placement, the closing of the private placement, the investors who will participate in the private placement, the proposed business plan of the Company; the Company’s commitment to advancing new cancer therapies; the ability of the Company to extract value from the Deep Docking AI platform; the Company’s ability to execute on its business plans while maintaining high standards of research; the ability of Pharma Inventor Inc. to accurately provide medicinal chemistry support; the projected timeline and effectiveness of the Company’s strategy to utilize the Deep Docking AI platform; and the Company’s ability to generate shareholder value. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events, or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of the Company. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, economic factors, regulatory factors, the equity markets generally and risks associated with growth and competition.

Although the Company has attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events, or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. The reader is referred to the Company’s most recent filings on SEDAR for a more complete discussion of all applicable risk factors and their potential effects, copies of which may be accessed through the Company’s profile page at www.sedar.com.

For Further Information Contact:

David Hyman, Chief Financial Officer
info@rakovinatherapeutics.com

Invest Relations & Media
Michelle Seltenrich
ir@rakovinatherapeutics.com
778-773-5432

Revascor Improves Survival and Reduces Major Morbidity in High-Risk Ischemic Heart Failure Patients With Inflammation




Revascor Improves Survival and Reduces Major Morbidity in High-Risk Ischemic Heart Failure Patients With Inflammation

Phase 3 trial results published in European Journal of Heart Failure identify key target population for Mesoblast allogeneic cell therapy

NEW YORK, Dec. 02, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced a key publication in the November 2024 online issue of the prestigious peer-reviewed European Journal of Heart Failure (EJHF), which reports that a single intramyocardial injection of the Company’s allogeneic cell therapy Revascor^® (rexlemestrocel-L) results in improved survival in high-risk patients with ischemic heart failure and inflammation.¹

Results from the randomized, controlled DREAM-HF trial in patients with chronic heart failure with reduced ejection fraction (HFrEF) identified the control group at highest risk of cardiovascular death as being those with ischemic etiology and inflammation and showed that a single intramyocardial injection of Mesoblast’s mesenchymal precursor cell therapy (MPCs; rexlemestrocel-L) resulted in a sustained reduction in cardiovascular mortality in these high-risk patients. This identifies the target HFrEF population that is responsive to REVASCOR therapy.

DREAM-HF’s lead investigator, Dr. Emerson C. Perin, MD, PhD, FACC, Medical Director at The Texas Heart Institute, said, “Mesoblast’s allogeneic MPCs may restore the balance between anti-inflammatory and pro-inflammatory cytokines in the damaged, inflamed heart. A single administration of MPCs appears sufficient to improve survival and other major clinical outcomes in high-risk HFrEF patients with inflammation. These effects are seen on top of existing treatments that target neurohormonal imbalances and congestion, providing a disease-modifying approach not achievable with standard-of-care alone.”

The newly published results showed that over a mean follow-up of 30 months in the DREAM-HF trial:

• Factors portending the greatest risk for cardiovascular death in control patients were inflammation (baseline plasma high-sensitivity C-reactive protein ≥2 mg/L; p=0.003) and ischemic HFrEF etiology (p=0.097), with increased cardiovascular death risk of 61% and 38%, respectively.
• A single intra-myocardial MPC administration significantly lowered the risk of cardiovascular death in HFrEF patients with inflammation regardless of whether plasma hsCRP or plasma IL-6 was used as inflammatory biomarker by 80% (p=0.003) and 60% (p=0.037) respectively.
• MPCs reduced 2-point MACE (heart attack or stroke) by 57% (p=0.016) and 3-point MACE (cardiovascular death, heart attack, stroke) by 35% (p=0.049) in patients with ischemic HFrEF (n=303) compared to controls.
• MPCs reduced 2-point and 3-point MACE by 88% (p=0.005) and 52% (p=0.018) respectively, in patients with ischemic HFrEF and inflammation (n=158) compared to controls.

“We are pursuing potential approval pathways for our STRO3-immunoselected and industrially manufactured heart failure product REVASCOR across the continuum from pediatric congenital heart disease to adults with ischemic HFrEF,” said Mesoblast Chief Executive Dr. Silviu Itescu. “Earlier this year we received feedback from the U.S. Food and Drug Administration (FDA) providing support for an accelerated approval pathway in end-stage ischemic HFrEF patients with a left ventricular assist device (LVAD). This new publication identifies the larger ischemic HFrEF population which responds to REVASCOR with mortality benefit.”

About Revascor^® (rexlemestrocel-L) in Heart Disease
REVASCOR is an allogeneic preparation of immunoselected and culture-expanded mesenchymal precursor cells (MPC) and is being developed as an immunomodulatory therapy to address the high degree of inflammation in the heart and cardiovascular system that is present across the spectrum of HFrEF patients ranging from New York Heart Association (NYHA) class II through end-stage disease, in order to reduce the high rate of major cardiovascular events and complications. This investigational therapy has been evaluated in two large placebo-controlled randomized studies in patients with chronic HFrEF. These consisted of a trial with 537 NYHA class II/III treated patients (DREAM-HF)² and a 159-patient trial in end-stage HFrEF patients implanted with a left ventricular assist device (LVAD).

Rexlemestrocel-L has US Food and Drug Administration (FDA) Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations for patients with end-stage HFrEF implanted with an LVAD.

About Chronic Heart Failure
Chronic heart failure (CHF) is characterized by poor heart function resulting in insufficient blood flow to the body’s vital organs and extremities. This condition affects approximately 6.5 million people in the United States and 26 million people globally with increasing prevalence and incidence. Chronic heart failure patients are commonly classified according to the New York Heart Association (NYHA) categories based on the patient’s physical limitations. Class I (mild) patients have no limitations while Class IV patients (severe/end stage) experience symptoms even at rest.

The mortality rate approaches 50% at 5 years as patients progress beyond NYHA early class II disease in parallel with increasing inflammation in the heart and in the circulation.^3,4 Despite recent approvals of new therapies for HFrEF, NYHA class II/III HFrEF patients with inflammation remain at high risk for cardiovascular death, heart attacks and strokes.

Over 100,000 patients annually in the US progress to end-stage heart failure (NYHA class IIIB/IV). These patients have a one-year mortality exceeding 50%.⁵ Use of LVADs in end-stage heart failure patients to improve survival is gaining momentum, with approximately 2,000 LVADs implanted as destination therapy annually in the US,⁶ the majority of whom have an ischemic etiology.

About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease, and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

References / Footnotes

1. Perin EC. Et al. Mesenchymal precursor cells reduce mortality and major morbidity in ischaemic heart failure with inflammation: DREAM-HF. Eur J Heart Fail 2024. https://doi.org/10.1002/ejhf.3522
2. Perin EC. Et al. Randomized Trial of Targeted Transendocardial Mesenchymal Precursor Cell Therapy in Patients with Heart Failure. JACC Vol. 81, No. 9, 2023. https://doi.org/10.1016/j.jacc.2022.11.061
3. AHA’s 2017 Heart Disease and Stroke Statistics
4. Ponikowski P., et al. Heart Failure: Preventing disease and death worldwide. European Society of Cardiology. 2014; 1: 4-25
5. Gustafsson F, Rogers JG. Left ventricular assist device therapy in advanced heart failure: patient selection and outcomes. European Journal of Heart Failure 2017;19:595-602.
6. Yuzefpolskaya M et al. Ann Thorac Surg 2023; 115:311-28

Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including any future decision that the FDA may make on the BLA for remestemcel-L for pediatric patients with SR-aGVHD), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For more information, please contact:

Molecular Templates Announces Receipt of Expected Notification of Deficiency from Nasdaq Related to Delayed filing of Quarterly Report on Form 10-Q and Failure to Meet Bid Price Requirements




Molecular Templates Announces Receipt of Expected Notification of Deficiency from Nasdaq Related to Delayed filing of Quarterly Report on Form 10-Q and Failure to Meet Bid Price Requirements

AUSTIN, Texas, Dec. 02, 2024 (GLOBE NEWSWIRE) — Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM” or the “Company”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, known as engineered toxin bodies, to create novel therapies with potent and differentiated mechanisms of action for cancer, announced that it has received an expected deficiency notification letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) on November 25, 2024. The notice indicated that MTEM is not in compliance with Nasdaq Listing Rule 5250(c)(1) (the “Listing Rule”) as a result of its failure to timely file its Quarterly Report on Form 10-Q for the period ended September 30, 2024 (the “Form 10-Q”), as described more fully in MTEM’s Form 12b-25 Notification of Late Filing (the “Form 12b-25”) filed with the Securities and Exchange Commission (the “SEC”) on November 15, 2024. The Listing Rule requires Nasdaq-listed companies to timely file all required periodic reports with the SEC. MTEM has until January 24, 2025 to submit a plan of compliance with respect to the notice.

On November 25, 2024, MTEM also receive a notice with respect to its failure to maintain a $1.00 bid price in accordance with the Nasdaq Rule 5550(a)(2) (the “Minimum Bid Price Requirement”) as the closing price of the Company’s common stock as reported by Nasdaq was less than $1.00 for the preceding 30 business days. In accordance with Nasdaq rules, MTEM has been provided a 180-calendar day compliance period, or until May 26, 2025, to regain compliance with the Minimum Bid Price Requirement. To regain compliance with the Minimum Bid Price Requirement, the closing bid price of the common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days during the 180-calendar day compliance period. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iii), if the price of the common stock is less than $0.10 during a compliance period, Nasdaq will issue a delisting determination for the common stock.

At this time, the Company has not yet determined whether to appeal these notices, submit plans of compliance or to take other action to address these deficiencies. The notices have no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Capital Market.

About Molecular Templates

Molecular Templates is a clinical-stage biopharmaceutical company focused on the discovery and development of next-generation ADCs. Our drug platform technology, known as Engineered Toxin Bodies (ETBs), leverages the resident biology of a genetically engineered toxin payload to create novel therapies with potent and differentiated mechanisms of action for cancer and various disease indications.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Molecular Templates disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future compliance with Nasdaq listing requirements, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Molecular Templates may identify forward-looking statements. Examples of such statements include, but are not limited to, statements regarding any future actions the Company may take regarding the notices received from Nasdaq, the future price of the Company’s common stock and the Company’s ability to maintain the listing of its common stock on Nasdaq or otherwise continue its operations.

Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Continued investment in the Company’s common stock is highly speculative at this point. Actual events or results may differ materially from those discussed in the forward-looking statements as a result of various factors including, but not limited to the following: the effects of the pending potential dissolution of the Company on its stockholders who are not currently expected to receive value for their shares of common stock; the continued availability of financing on commercially reasonable terms; whether Molecular Templates’ cash resources will be sufficient to fund any future operations; the results of MTEM’s clinical studies which may be unable to resume in the near-term; the ability to effectively operate MTEM and retain key employees post-MTEM’s previously announced restructuring and reductions in force; the ability of MTEM to maintain the continued listing of its common stock on Nasdaq; the ability of MTEM to resume its regular and required Exchange Act reporting obligations which the Company is currently unable to do; and those risks identified under the heading “Risk Factors” in Molecular Templates’ filings with the Securities and Exchange Commission, including its most recently filed Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and any subsequently filed reports. Any forward-looking statements contained in this press release speak only as of the date hereof, and Molecular Templates specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.

Contact

Michelle Iwamoto-Fan

michelle.iwamotofan@mtem.com

Vaxart Completes Enrollment of Sentinel Cohort in Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate




Vaxart Completes Enrollment of Sentinel Cohort in Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate

SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT) today announced completion of enrollment of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. The sentinel cohort comprised of 400 participants, with 200 receiving Vaxart’s COVID-19 vaccine candidate and 200 receiving an approved mRNA vaccine comparator.

“We are pleased to complete the enrollment of the sentinel cohort, an important milestone that reflects the collaboration of our entire team, as well as the trust and commitment of the participants and investigators involved,” said Dr. James F. Cummings, Vaxart’s Chief Medical Officer. “We look forward to DSMB and FDA review followed by the planned initiation of the Phase 2b trial’s second portion. Our continued progress brings us closer to our goal of potentially demonstrating advantages of our mucosal technology against an approved mRNA vaccine.”

An independent Data and Safety Monitoring Board (DSMB) and the U.S. Food and Drug Administration (FDA) will review 30-day safety data from the sentinel cohort.

Upon favorable review by the DSMB and FDA, the study will progress after Biomedical Advanced Research and Development Authority (BARDA) approval to the second part of the trial by enrolling approximately 10,000 participants. The trial will strive to enroll participants in line with U.S. demographics, as well as including at least 25% over the age of 65.

The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection.

The full Phase 2b trial will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events. The primary endpoint is relative efficacy of Vaxart’s COVID-19 vaccine candidate compared to an approved mRNA comparator for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.

Funding for this award was received under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to $456 million. This project has been funded with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); BARDA, under Other Transaction (OT) number 75A50123D00005.

As a pioneer of oral vaccines, Vaxart was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19.

About Vaxart
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Note Regarding Forward-Looking Statements 
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from preclinical and clinical trials and the timing of such results, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “anticipate,” “plan,” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart’s expectations regarding clinical results and trial data, and the timing of receiving and reporting such clinical results and trial data; and Vaxart’s expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners’ control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to resolve pending legal matters; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Contact            

Vaxart Media and Investor Relations:   
Matt Steinberg     
FINN Partners
IR@vaxart.com
(646) 871-8481

Vaxart Completes Enrollment of Sentinel Cohort in Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate




Vaxart Completes Enrollment of Sentinel Cohort in Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate

SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT) today announced completion of enrollment of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. The sentinel cohort comprised of 400 participants, with 200 receiving Vaxart’s COVID-19 vaccine candidate and 200 receiving an approved mRNA vaccine comparator.

“We are pleased to complete the enrollment of the sentinel cohort, an important milestone that reflects the collaboration of our entire team, as well as the trust and commitment of the participants and investigators involved,” said Dr. James F. Cummings, Vaxart’s Chief Medical Officer. “We look forward to DSMB and FDA review followed by the planned initiation of the Phase 2b trial’s second portion. Our continued progress brings us closer to our goal of potentially demonstrating advantages of our mucosal technology against an approved mRNA vaccine.”

An independent Data and Safety Monitoring Board (DSMB) and the U.S. Food and Drug Administration (FDA) will review 30-day safety data from the sentinel cohort.

Upon favorable review by the DSMB and FDA, the study will progress after Biomedical Advanced Research and Development Authority (BARDA) approval to the second part of the trial by enrolling approximately 10,000 participants. The trial will strive to enroll participants in line with U.S. demographics, as well as including at least 25% over the age of 65.

The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection.

The full Phase 2b trial will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events. The primary endpoint is relative efficacy of Vaxart’s COVID-19 vaccine candidate compared to an approved mRNA comparator for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.

Funding for this award was received under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to $456 million. This project has been funded with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); BARDA, under Other Transaction (OT) number 75A50123D00005.

As a pioneer of oral vaccines, Vaxart was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19.

About Vaxart
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Note Regarding Forward-Looking Statements 
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from preclinical and clinical trials and the timing of such results, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “anticipate,” “plan,” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart’s expectations regarding clinical results and trial data, and the timing of receiving and reporting such clinical results and trial data; and Vaxart’s expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners’ control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to resolve pending legal matters; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Contact            

Vaxart Media and Investor Relations:   
Matt Steinberg     
FINN Partners
IR@vaxart.com
(646) 871-8481

Cytokinetics to Participate in December Investor Conferences




Cytokinetics to Participate in December Investor Conferences

SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Company is scheduled to participate in the following December investor conferences:

• 7^th Annual Evercore ISI HealthconX Conference: Cytokinetics will participate in a fireside chat on Tuesday, December 3, 2024 at 9:35 AM Eastern Time at the Loews Coral Gables Hotel in Coral Gables, FL.
• 36^th Annual Piper Sandler Healthcare Conference: Cytokinetics will participate in a fireside chat on Wednesday, December 4, 2024 at 8:00 AM Eastern Time at the Lotte New York Palace in New York, NY.

Interested parties may access the live webcasts of the fireside chats by visiting the Investors & Media section of the Cytokinetics website at http://www.cytokinetics.com. The webcast replays will be archived on the Cytokinetics website for 90 days following the conclusion of the event.

About Cytokinetics

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial evaluating aficamten, a next-in-class cardiac myosin inhibitor, in obstructive hypertrophic cardiomyopathy (HCM), Cytokinetics is progressing regulatory submissions for aficamten for the treatment of obstructive HCM in the US, Europe, and China. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of heart failure with preserved ejection fraction (HFpEF), and CK-089, a fast skeletal muscle troponin activator (FSTA) for the potential treatment of a specific type of muscular dystrophy.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlined in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

Cytokinetics to Participate in December Investor Conferences




Cytokinetics to Participate in December Investor Conferences

SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Company is scheduled to participate in the following December investor conferences:

• 7^th Annual Evercore ISI HealthconX Conference: Cytokinetics will participate in a fireside chat on Tuesday, December 3, 2024 at 9:35 AM Eastern Time at the Loews Coral Gables Hotel in Coral Gables, FL.
• 36^th Annual Piper Sandler Healthcare Conference: Cytokinetics will participate in a fireside chat on Wednesday, December 4, 2024 at 8:00 AM Eastern Time at the Lotte New York Palace in New York, NY.

Interested parties may access the live webcasts of the fireside chats by visiting the Investors & Media section of the Cytokinetics website at http://www.cytokinetics.com. The webcast replays will be archived on the Cytokinetics website for 90 days following the conclusion of the event.

About Cytokinetics

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial evaluating aficamten, a next-in-class cardiac myosin inhibitor, in obstructive hypertrophic cardiomyopathy (HCM), Cytokinetics is progressing regulatory submissions for aficamten for the treatment of obstructive HCM in the US, Europe, and China. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of heart failure with preserved ejection fraction (HFpEF), and CK-089, a fast skeletal muscle troponin activator (FSTA) for the potential treatment of a specific type of muscular dystrophy.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlined in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

M3 Group Joins MEDIROM Mother Labs’ Series A Financing Round at JPY9 Billion (as of December 1, 2024, approximately USD $59,000,000) Pre-Money Valuation




M3 Group Joins MEDIROM Mother Labs’ Series A Financing Round at JPY9 Billion (as of December 1, 2024, approximately USD $59,000,000) Pre-Money Valuation

TOKYO, Dec. 02, 2024 (GLOBE NEWSWIRE) — MEDIROM Healthcare Technologies Inc. (NASDAQ: MRM) (“MEDIROM”) announces that M3, Inc. (TOKYO PRIME: 2413), or an affiliate within the M3 group, is participating in the Series A equity financing round of MEDIROM MOTHER Labs Inc., a subsidiary of MEDIROM. NFES Technologies Inc. is the lead investor of the Series A financing round at a pre-money valuation of JPY9 billion. Additional information is available here: https://medirom.co.jp/en/ir/20240824/6148%09

Forward-Looking Statements Regarding MEDIROM

Certain statements in this press release are forward-looking statements for purposes of the safe harbor provisions under the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may include estimates or expectations about MEDIROM’s possible or assumed operational results, financial condition, business strategies and plans, market opportunities, competitive position, industry environment, and potential growth opportunities. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “design,” “target,” “aim,” “hope,” “expect,” “could,” “intend,” “plan,” “anticipate,” “estimate,” “believe,” “continue,” “predict,” “project,” “potential,” “goal,” or other words that convey the uncertainty of future events or outcomes. These statements relate to future events or to MEDIROM’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause MEDIROM’s actual results, levels of activity, performance, or achievements to be different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond MEDIROM’s control and which could, and likely will, affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects MEDIROM’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to MEDIROM’s operations, results of operations, growth strategy and liquidity.

More information on these risks and other potential factors that could affect MEDIROM’s business, reputation, results of operations, financial condition, and stock price is included in MEDIROM’s filings with the Securities and Exchange Commission (the “SEC”), including in the “Risk Factors” and “Operating and Financial Review and Prospects” sections of MEDIROM’s most recently filed periodic report on Form 20-F and subsequent filings, which are available on the SEC website at www.sec.gov. MEDIROM assumes no obligation to update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ from those anticipated in these forward-looking statements, even if new information becomes available in the future.

ABOUT M3, Inc.
M3 is a one of a kind venture company that operates a multitude of global services centred around its physician platform such as m3.com.
M3 is the first company incorporated after the year 2000 to be included in the Nikkei 225 Index. Its 330,000+ Japanese and 6,500,000+ global physician member panel serves as a central platform in advancing innovation and reform across healthcare worldwide.

Tokyo Stock Exchange Prime Market (Securities code 2413)
1-11-44 Akasaka Minato-ku, Tokyo 107-0052 JAPAN
Web https://corporate.m3.com/en

ABOUT MEDIROM MOTHER Labs Inc.
A subsidiary of MEDIROM Healthcare Technologies Inc. (NASDAQ: MRM), focuses on the health-tech sector. The company’s core activities include the “Specific Health Guidance Program” offered through the “Lav” health application and development and sales of the 24/7 recharge-free MOTHER Bracelet smart tracker. By leveraging the features of the recharge-free MOTHER Bracelet, MOTHER Labs offers customizable health management solutions across diverse sectors, including caregiving, logistics, manufacturing, etc.

MEDIROM Healthcare Technologies Inc.
NASDAQ Symbol: MRM
Tradepia Odaiba, 2-3-1 Daiba, Minato-ku, Tokyo, Japan
Web https://medirom.co.jp/en
Contact: ir@medirom.co.jp

MEDIROM MOTHER Labs Inc.
Tradepia Odaiba, 2-3-1 Daiba, Minato-ku, Tokyo, Japan

MOTHER Bracelet is the world’s first* 24/7 recharge-free smart tracker. It uses innovative technology from a Silicon Valley tech company that allows for power generation based on temperature differences between body and surrounding air. The recharge-free feature eliminates the risk of data loss when a device is taken off for recharge. MOTHER Bracelet records five basic metrics: heart rate, calories burned, body surface temperature, step count, and sleep.
Official Website: https://mother-bracelet.com