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Takeda Announces Approval of CUVITRU™ Subcutaneous Immunoglobulin in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia

Takeda Announces Approval of CUVITRU™ Subcutaneous Immunoglobulin in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia

  • Approval is Based on Clinical Studies Conducted in Japan, Europe and North America Confirming the Efficacy and Safety of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution]
  • CUVITRU is Takeda’s First Subcutaneous Immunoglobulin Plasma Therapy in Japan, Delivering on the Company’s Commitment to Reach Patients with High Unmet Needs

OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Takeda(TSE:4502/NYSE:TAK) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of CUVITRU™ [Immune Globulin Subcutaneous (Human), 20% Solution] in patients aged 2 years and older with agammaglobulinemia or hypogammaglobulinemia1, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID)2. The approval marks Takeda’s first subcutaneous immunoglobulin (SCIG) therapy for patients in Japan.

The approval is based on results from a Phase 3 clinical trial that evaluated the efficacy, safety, tolerability and pharmacokinetics of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution]in Japanese patients with PID (NCT04346108), as well as two Phase 2/3 clinical trials conducted in patients with PID in North America (NCT01218438) and Europe (NCT01412385). Results from the clinical trial in 17 patients in Japan confirmed its efficacy and safety profile1. No serious or severe adverse events were reported, and CUVITRU was well-tolerated. The most frequently reported adverse reactions were injection site swelling in four patients (23.5%) and injection site erythema in three patients (17.6%)1 during CUVITRU treatment. Previously reported clinical trial results also confirmed the efficacy and safety of CUVITRU.

“We are delighted that CUVITRU, approved in more than 30 countries worldwide, has now been approved in Japan as our first subcutaneous immunoglobulin treatment for agammaglobulinemia or hypogammaglobulinemia,” said Naoyoshi Hirota, regional head of research & development for Takeda’s Plasma-Derived Therapies Business Unit in Japan. “Patients with immunodeficiency often contract serious infections, including pneumonia, sepsis and other recurring infections. Immunoglobulin replacement therapy is the standard of care, and we are proud to offer a new flexible dosing regimen to patients in Japan.”

Timely diagnosis of PID is problematic in Japan and treatment with immunoglobulins is currently much lower than in other parts of the world3,4. Patient demand for plasma-derived therapies (PDTs) is expected to grow significantly in the coming years, and Takeda is leading regulatory efforts and discussions to elevate the standard of care in Japan and introduce more of Takeda’s PDT portfolio into the country.

“Takeda is proud to build on our long and rich Japanese heritage by continuing to invest in and expand our PDT offerings to address the needs of patients,” said Kristina Allikmets, head of research & development for Takeda’s Plasma-Derived Therapies Business Unit. “Hand in hand with our recent investment in an end-to-end global plasma manufacturing facility in Osaka, the approval of CUVITRU marks the start of our commitment to bringing our broad and differentiated global PDT portfolio to immunodeficient patients in Japan over the next decade.”

About Agammaglobulinemia or Hypogammaglobulinemia

Agammaglobulinemia is an inherited disorder caused by a gene defect that blocks the growth of normal, mature immune cells called B lymphocytes, and produces antibodies5. Hypogammaglobulinemia describes a condition in which patients have low levels of antibodies and can be both due to inherited genetic conditions, or caused by secondary effects, such as chemotherapy, certain comorbid disorders, or the use of immunosuppressants2. Individuals with any form of antibody deficiency frequently experience recurring infections, and immunoglobulin replacement therapy can increase the level of antibodies in the body.

About Primary Immunodeficiency and Secondary Immunodeficiency

Primary immunodeficiency (PID) describes a heterogenous group of more than 480 rare genetic diseases wherein part of the immune system is missing or not functioning properly6. Secondary immunodeficiency (SID) may be defined as an impairment of the immune response resulting from conditions or factors extrinsic to the immune system. SID may occur as a consequence of malnutrition, metabolic disorders, use of immunosuppressive medications, chronic infections, malignancies, or severe trauma7. Due to their impaired immune system, patients with PID and SID may be more susceptible to infection and it may take longer to recover from it. In patients with antibody deficiency and increased susceptibility and/or persistent infections, substitution with functional antibodies (immunoglobulin replacement therapy) is the standard of care to support the immune system’s functioning7.

About CUVITRU™ [Immune Globulin Subcutaneous (Human), 20% Solution]

CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated in Japan as a treatment for agammaglobulinemia or hypogammaglobulinemia in patients aged 2 years and older. It was developed as a treatment to help prevent infection in adult and pediatric patients with PID or SID. As of May 2022, it has been approved in over 30 countries.

CUVITRU Product Overview in Japan

Brand Name

CUVITRU 20% S.C. Infusion 2 g/10 mL, 4 g/20 mL, 8 g/40 mL

Generic Name

pH4-Treated Acidic Normal Human Immunoglobulin (Subcutaneous injection)

Indications

Agammaglobulinemia or Hypogammaglobulinemia

Dosage and

Administration

 

Normally, 50 ~ 200 mg (0.25 ~ 1 mL)/kg body weight of human immunoglobulin G is administered subcutaneously once a week. In case of every 2 weeks regimen, 2-fold higher dose than once-a-week regimen (100 ~ 400 mg [0.5 ~ 2 mL]/kg body weight) will be administered subcutaneously. The dose and dosing frequency of once-a-week or every-2-weeks regimen may be adjusted according to the patient’s condition.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

References

  1. CUVITRU Subcutaneous Injection Package Insert in Japan.

  2. Pimenta et al., Hypogammaglobulinemia: a diagnosis that must not be overlooked. BJMBR, 2019;52(10): e8926, http://dx.doi.org/10.1590/1414-431X20198926.

  3. The Marketing Research Bureau (MRB). Plasma-Derived Medicinal Products (PDMPs) and Plasma Supply into the Future. January 2020.

  4. Kohsuke et al., Physician awareness and understanding of primary immunodeficiency disorders: a web-based study in Japan, Immunological Medicine, 2023; 46:1, 45-57, doi: 10.1080/25785826.2022.2137966.

  5. National Organization for Rare Disorders: https://rarediseases.org/rare-diseases/agammaglobulinemia/.

  6. Tangye et al., Human inborn errors of immunity: 2022 update on the classification from the international union of immunological societies expert committee. J Clin Immunol. 2022 Oct;42(7):1473-1507. doi: 10.1007/s10875-022-01289-3. Epub 2022 Jun 24. https://pubmed.ncbi.nlm.nih.gov/35748970.

  7. Karen S. Tuano,y; Neha Seth, Javier Chinen. Secondary immunodeficiencies. Ann Allergy Asthma Immunol 127 (2021) 617-626.

 

Media Contacts:

International Media

Lauren Padovan

[email protected]

+1 (617) 431-8028

Japan Media

Shigeyuki Matsui

[email protected]

+81 (80) 3594-2460

KEYWORDS: North America United States Asia Pacific Europe Japan Massachusetts

INDUSTRY KEYWORDS: Biotechnology General Health Infectious Diseases Health Pharmaceutical

MEDIA:

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Regeneron Completes Acquisition of Decibel Therapeutics, Adding Promising Gene Therapy Programs for Hearing Loss

TARRYTOWN, N.Y., Sept. 25, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it has successfully completed its acquisition of Decibel Therapeutics, Inc., strengthening the company’s gene therapy and auditory programs.

The acquisition of Decibel builds on prior collaboration between the companies and includes three ongoing gene therapy programs targeting different forms of congenital, monogenic hearing loss. The most advanced clinical-stage candidate is DB-OTO, which is currently being studied in the global Phase 1/2 CHORDTM clinical trial, and is an investigational cell-selective, adeno-associated virus (AAV) gene therapy designed to provide durable, physiological hearing to individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. Preclinical programs include AAV.103 for people with GJB2-related hearing loss and AAV.104 for people with stereocilin (STRC)-related hearing loss.

“After several years of successful collaboration, the integration of Decibel’s programs, capabilities and accomplished team will further bolster Regeneron’s genetic medicines portfolio and advance our mission of helping patients around the globe,” said Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron. “We will continue to strategically deploy capital by selectively pursuing deals that secure access to novel technologies and approaches that are complementary to our technologies, portfolio and strengths in research.”

“As we advance Regeneron’s commitment to genetic medicine, we welcome our new colleagues and their important expertise in the biology of auditory disorders,” said George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer of Regeneron. “In addition to DB-OTO, we have worked with Decibel to build a rich pipeline of programs targeting congenital hearing loss caused by single-gene mutations, including the more common GJB2 and STRC mutations. We are actively expanding our expertise in cutting-edge genetic medicine approaches, which currently includes gene silencing, gene editing and gene therapy technologies with the potential to address many serious and hard-to-treat diseases.”

The tender offer by Regeneron for shares of Decibel expired one minute after 11:59 p.m., Eastern Time, on Friday, September 22, 2023. Computershare, the depository and paying agent for the tender offer, advised Regeneron that as of the tender offer expiration, a total of 19,797,530 shares had been validly tendered and not validly withdrawn, representing, together with the shares held by Regeneron, approximately 86.1% of the outstanding shares. As a result of the completion of the offer, all holders of shares that were validly tendered become entitled to $4.00 per share (without interest), with an additional non-tradeable contractual contingent value right (CVR) to receive up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for Decibel’s lead investigational candidate, DB-OTO, within specified time periods. Subject to the terms of the CVR agreement (including adjustments for CVRs received in exchange for certain options with an exercise price greater than $4.00 per share), CVR holders will become entitled to receive contingent payments as follows: (i) $2.00 in cash, upon the fifth participant being administered with DB-OTO in a clinical trial on or prior to December 31, 2024 (the DB-OTO Milestone); and (ii) $1.50 in cash, upon (a) the first participant being administered with DB-OTO in a registration enabling trial (as defined in the CVR Agreement) or (b) acceptance for review of a Biologics License Application by the U.S. Food and Drug Administration, a Marketing Authorization Application by the European Medicines Agency or the U.K. Medicines and Healthcare Products Regulatory Agency, or an equivalent application by the applicable national regulatory authority in any of Germany, France, Italy or Spain for DB-OTO, whichever occurs first, on or prior to December 31, 2028; provided the DB-OTO Milestone is achieved on or prior to December 31, 2024. There can be no assurance that any payments will be made with respect to the CVR. Following its acceptance of the tendered shares, Regeneron completed its acquisition of Decibel through a second step merger of Symphony Acquisition Sub, Inc., with and into Decibel. Upon consummation of the merger, all holders of shares that were not validly tendered will be converted into the right to receive the same consideration per share paid pursuant to the offer. As a result of the acquisition, Decibel common stock has ceased to be traded on the Nasdaq Global Market.

Any changes to Regeneron’s 2023 GAAP and non-GAAP financial guidance as a result of this transaction will be reflected in the guidance update to be provided in conjunction with Regeneron’s third quarter 2023 earnings announcement.

Regeneron’s legal advisor for the transaction is Wachtell, Lipton, Rosen & Katz. Centerview Partners LLC and Leerink Partners LLC served as Decibel’s financial advisors and Wilmer Cutler Pickering Hale and Dorr LLP served as Decibel’s legal advisor.

About Regeneron

Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, Regeneron’s unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in Regeneron’s laboratories. Regeneron’s medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

For additional information about the company, please visit www.regeneron.com or follow Regeneron on LinkedIn.

Forward-looking Statements

This press release contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “propose,” “provide,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Risks that may cause these forward-looking statements to be inaccurate include, without limitation: risks related to Regeneron’s ability to realize the anticipated benefits of the acquisition of Decibel Therapeutics, Inc. (“Decibel”), including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period and that Regeneron and Decibel will not be integrated successfully; the effects of the transaction on relationships with employees, other business partners or governmental entities; negative effects of this announcement or the consummation of the acquisition on the market price of Regeneron’s common stock and/or Regeneron’s operating results; significant transaction costs; unknown liabilities; Regeneron’s ability to continue to conduct research and clinical programs; Regeneron’s ability to manage its supply chains; Regeneron’s ability to manage net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”); the nature, timing, and possible success and therapeutic applications of Regeneron’s Products, product candidates being developed by Regeneron and/or its collaborators or licensees (including without limitation the investigational gene therapy DB-OTO for the treatment of congenital hearing loss and the other gene therapy programs discussed or referenced in this press release (collectively, “Regeneron’s Product Candidates”)), the extent to which the results from the research and development programs conducted by Regeneron and/or its respective collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates, and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates; uncertainty regarding each of the contingent value rights milestones referenced in this press release and the possibility that any or all of such milestones will never be achieved and that some or all milestone payments may not be made; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron and/or its collaborators to manufacture and manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products or Regeneron’s Product Candidates; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products or Regeneron’s Product Candidates; and the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron’s businesses.

A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2022. Any forward-looking statements are made based on the current beliefs and judgments of Regeneron’s management, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Except as required by law, Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron Media Contact
Ella Campbell
Tel: +1 914-847-7017
[email protected]

Regeneron Investor Contact

Vesna Tosic
Tel: +1 914-847-5443
[email protected]



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Celldex Therapeutics to Present at Cantor Global Healthcare Conference

HAMPTON, N.J., Sept. 25, 2023 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in a fireside chat at the Cantor Global Healthcare Conference on Tuesday, September 26th at 1:00 pm ET. A webcast of the presentation will be available on the “Events & Presentations” page of the “Investors & Media” section of the Celldex website. A replay will be available for 90 days following the event.

About Celldex Therapeutics, Inc.

Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer. Visit www.celldex.com.

Company Contact

Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
[email protected]

Patrick Till
Meru Advisors
(484) 788-8560
[email protected]



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Mama’s Creations to Participate in Upcoming Investor Conferences

EAST RUTHERFORD, NJ, Sept. 25, 2023 (GLOBE NEWSWIRE) —
Mama’s Creations, Inc. (NASDAQ: MAMA), a leading national marketer and manufacturer of fresh Deli prepared foods, today announced that management was invited and will attend the iAccessAlpha Top 10 Ideas from the Buyside event, the LD Micro Main Event XVI, the 14th Annual Craig Hallum Alpha Select Conference and the 12th Annual ROTH Deer Valley Conference in the second half of 2023.

Adam L. Michaels, Chairman and CEO of Mama’s Creations, is scheduled to host one-on-one meeting with institutional investors at each event and will host a webcasted presentation at both the iAccessAlpha and LD Micro investor conferences as follows.

To view each presentation, please reference the webcast links below:

Top 10 Best Ideas from the Buyside –
Hosted by
iAccess
A
lpha

Date: Wednesday, September 27th, 2023
Time: 1:00 p.m. Eastern time
Location: Virtual
Format: Presentation and 1×1 Meetings
Webcast Link: https://www.webcaster4.com/Webcast/Page/2992/49084

LD Micro Main Event XVI

Date: Tuesday, October 3rd, 2023
Time: 9:00 a.m. Pacific time
Location: Los Angeles, CA
Format: Presentation and 1×1 Meetings
Webcast: https://me23.sequireevents.com/

14

th

Annual Craig Hallum Alpha Select Conference

Date: Thursday, November 16th, 2023
Location: New York, NY
Format: 1×1 Meetings Only

12

th

Annual ROTH Deer Valley Conference

Date: Thursday, December 14th – Friday, December 15th, 2023
Location: Park City, UT
Format: 1×1 Meetings Only

Adam L. Michaels commented: “I look forward to discussing the significant progress we made in the second quarter, as well as our go-forward catalysts for growth, with institutional investors at upcoming investor conferences throughout the fourth quarter. Our revamped sales & marketing organization positions us to begin to realize more robust growth in the second half, leveraging our continued margin gains to reinvest in trade and promotion, ultimately enabling us to enhance cross-selling efforts and aggressively take market share. Taken together, I firmly believe we are well positioned to continue to create sustainable value for our fellow shareholders over the long-term”

A live audio webcast and archive of each presentation will be available using the respective links above. Registration is mandatory for conference participation. For more information or to schedule a meeting with management, please contact MZ Group at [email protected].

About Mama
’s Creations,
Inc.

Mama’s Creations, Inc. (NASDAQ: MAMA) is a leading marketer and manufacturer of fresh deli prepared foods, found in over 8,000 grocery, mass, club and convenience stores nationally. The Company’s broad product portfolio, born from a rich history in Italian foods, now consists of a variety of high quality, fresh, clean and easy to prepare foods to address the needs of both our consumers and retailers. Our vision is to become a one-stop-shop deli solutions platform, leveraging vertical integration and a diverse family of brands to offer a wide array of prepared foods to meet the changing demands of the modern consumer. For more information, please visit https://mamascreations.com.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may,” “future,” “plan” or “planned,” “will” or “should,” “expected,” “anticipates,” “draft,” “eventually” or “projected.” You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in the Company’s 10-K for the fiscal year ended January 31, 2023 and other filings made by the Company with the Securities and Exchange Commission.

Investor Relations Contact:

Lucas A. Zimmerman
Director
MZ Group – MZ North America
(949) 259-4987
[email protected]
www.mzgroup.us



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QEP Completes Sale of Certain Harris Flooring Group Assets to Marquis Industries

BOCA RATON, Fla., Sept. 25, 2023 (GLOBE NEWSWIRE) — Q.E.P. CO., INC. (OTCQX: QEPC) (the “Company” or “QEP”) today announced that, on September 20, 2023, it completed the sale of certain assets of its Harris Flooring Group to Marquis Industries, Inc. (“Marquis Industries”), a subsidiary of Live Ventures Incorporated (Nasdaq: LIVE), in a transaction valued at approximately $10 million.

The purchased assets include the Naturally Aged Flooring™, Harris®, Kraus® and Heritage Mill® brands in North America, as well as related inventory and associated domain names and websites. Marquis Industries has also extended offers of employment to substantially all Harris Flooring Group employees. QEP’s primary flooring-related businesses in tools, adhesives, underlayment and accessory products are not included in this transaction.

Len Gould, President & CEO, The Americas, of QEP said, ”We believe Marquis Industries is the proper steward going forward for the Harris Flooring Group. QEP will continue to focus on what we do best, our core business of Flooring Tools, Adhesives, and Underlayment.”

“Across the globe, the QEP family of brands dominates the sundry categories in flooring. This divestiture will enable us to add more time, focus, and scale to our growth plan and speed to our Innovation-Roadmap.”

As the Company is currently in the process of selling the remaining assets of the Harris Flooring Group, the Company cannot at this time make a good faith determination of cost estimates, or ranges of cost estimates, associated with the sale of all Harris Flooring Group assets. If required, the Company will provide such information at such time as its management is able in good faith to estimate the amount, or range of amounts, of these costs.

About QEP

Founded in 1979, Q.E.P. Co., Inc. is a leading designer, manufacturer and distributor of a broad range of best-in-class installation solutions for commercial and home improvement projects worldwide. QEP offers a comprehensive line of specialty installation tools, adhesives, and underlayment. QEP sells its products throughout the world to home improvement retail centers, professional specialty distribution outlets, and flooring dealers under brand names including QEP®, LASH®, ROBERTS®, Capitol®, Premix-Marbletite® (PMM), Vitrex®, Brutus®, Homelux®, PRCI®, Plasplugs®, and Tomecanic®.

QEP is headquartered in Boca Raton, Florida with offices in Canada, Europe, Asia, Australia and New Zealand. Please visit our website at www.qepcorporate.com.

Forward-Looking Statements

All statements contained in this press release, other than statements of historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning.  Forward-looking statements include, but are not limited to, statements regarding the Company’s business following the sale and statements regarding the anticipated pre-tax charges and disposal costs. Any forward-looking statements contained herein are based on current expectations and beliefs, and are subject to a number of risks and uncertainties, including those listed in the Company’s annual report, as such risk factors may be amended, supplemented or superseded from time to time by other reports and disclosures made by the Company. Forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, manufacturing issues that may arise, patent positions and litigation, among other factors.  The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.

CONTACT:

Q.E.P. Co., Inc.
Enos Brown
Executive Vice President and
Chief Financial Officer
561-994-5550 



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urban-gro, Inc. Announces Upcoming Fall 2023 Conference Participation

LAFAYETTE, Colo., Sept. 25, 2023 (GLOBE NEWSWIRE) — urban-gro, Inc. (Nasdaq: UGRO) (“urban-gro” or the “Company”), an integrated professional services consulting firm, today announced its participation in the following investor and industry conferences.

  • Benzinga Cannabis Capital Conference, Chicago, IL, September 27-28: Bradley Nattrass, Chairman & CEO will be participating on a panel on Wednesday, September 27 at 11:00 a.m. CT on the topic of Beyond Buds: How and Why Ancillary Companies are Diversifying. Mr. Nattrass will also be available for one-on-one investor meetings.
  • A.G.P Virtual Cannabis Conference, virtual, October 4: Bradley Nattrass, Chairman & CEO and Dick Akright, CFO will be participating in one-on-one investor meetings.
  • ThinkEquity Conference, New York, NY, October 19: Bradley Nattrass, Chairman & CEO will host a presentation and along with Dick Akright, CFO, be available for one-on-one investor meetings.
  • Roth MKM 3rd Annual AgTech Answers Conference, New York, NY, November 14: Bradley Nattrass, Chairman & CEO and Dick Akright, CFO will be participating in one-on-one investor meetings.
  • MJBizCon 2023, Las Vegas, NV, November 29 – December 1: urban-gro will be exhibiting in booth 34023 and hosting private on-site meetings in Convention Center suite S112.

To schedule a one-on-one meeting with management at these conferences, attendees should contact [email protected] or their conference host representative.

About urban-gro, Inc.

urban-gro, Inc.® (Nasdaq: UGRO) is an integrated professional services consulting firm delivering professional services and solutions across architecture, design, engineering, equipment integration, and construction management. Our multi-sector expertise encompasses a diverse set of projects across a host of industries such as Controlled Environment Agriculture (“CEA”), light industrial, healthcare, hospitality, laboratories and more. Our dedicated and innovative team is fueled by a commitment to empower our clients by providing exceptional customer experiences throughout the project lifecycle and beyond, including post-operational support. With offices across North America and in Europe, we deliver Your Vision – Built. Learn more by visiting www.urban-gro.com.

Investor Contacts:

Dan Droller: urban-gro, Inc.
Investor Relations
-or-
Jeff Sonnek: ICR, Inc.
(720) 730-8160
[email protected]

Media Contact:

Patricia Whyte – MATTIO Communications
(551) 795-7315
[email protected]



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FDA Issues Complete Response Letter (CRL) for UDENYCA® ONBODY™ Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-Party Filler; Coherus Also Announces Completion of Toripalimab FDA Inspections

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No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing were identified in the UDENYCA® ONBODY™ CRL –

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No additional UDENYCA® ONBODY™ clinical data or trials have been requested by the FDA –

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Toripalimab inspections completed
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REDWOOD CITY, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS), a commercial-stage biopharmaceutical company focused on the research, development, and commercialization of innovative immunotherapies to treat cancer, announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) supplement for UDENYCA® ONBODY™, the company’s on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), solely due to an ongoing review of inspection findings at a third-party filler. The CRL did not identify any issues with the UDENYCA® ONBODY™ clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing, and no additional data or trials have been requested. Coherus is committed to working closely with the FDA and the third-party filler to bring UDENYCA® ONBODY™ to cancer patients requiring pegfilgrastim treatment as quickly as possible.


Coherus also announced completion of FDA’s toripalimab inspections


Coherus also announced today that the FDA has completed the clinical study site inspections of three clinical sites in China that enrolled subjects in the two pivotal clinical trials supporting the toripalimab BLA for the treatment of metastatic or recurrent nasopharyngeal carcinoma (NPC) as first-line treatment or as second or greater line treatment. Only one site received an FDA Form 483, with one observation noted. Coherus believes the observation is readily addressable. Coherus continues to anticipate potential approval for toripalimab by year end 2023.

“We are pleased the FDA has completed the review elements for the OBI and toripalimab applications,” said Dr. Theresa LaVallee, Coherus Chief Development Officer. “We will work with the third-party filler to address the issues and resubmit the UDENYCA® ONBODY™ application as quickly as possible. Having completed all the required review elements of the toripalimab BLA, we will continue to work collaboratively with the FDA to bring toripalimab, with its substantial improvement in survival compared to chemotherapy, to NPC patients. NPC is a rare cancer with high unmet medical need that has no drugs approved for treatment of this disease in the U.S.”

About Coherus BioSciences

Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology.

Through an in-licensing agreement with Shanghai Junshi Biosciences Ltd., Coherus is developing toripalimab, an anti-PD-1 antibody, in the United States and Canada. A BLA for toripalimab for the treatment of nasopharyngeal carcinoma is under review by the FDA. Toripalimab is approved in China for the treatment of melanoma, urothelial cancer, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and non-small cell lung cancer.

Through its acquisition of Surface Oncology, Coherus’ immuno-oncology pipeline now includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug (SRF388) is a novel anti-IL-27 antibody currently being evaluated in Phase 1/2 clinical trials in lung and liver cancer. CHS-114 (SRF114) is a highly selective, competitively positioned anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors. There are also two out-licensed partnership programs to advance its next-generation cancer therapies.

Coherus’ earlier-stage immuno-oncology pipeline targets immune-suppressive mechanisms in the tumor microenvironment, including CHS-006, a TIGIT-targeted antibody, being evaluated in a Phase 1/2 clinical trial in combination with toripalimab in patients with advanced solid tumors, and CHS-1000, a preclinical program targeting the novel pathway ILT4.

Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®, and YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira®.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding whether Coherus’ innovative immuno-oncology pipeline will be synergistic with its proven commercial capabilities in oncology and whether the FDA’s Form-483 observations will be readily addressable and have no impact on approval timing .

Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks related to our existing and potential collaboration partners, the risks and uncertainties inherent in the clinical drug development process; risks relating to competition; risks of the drug development position of Coherus’ competitors; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, international aspects of Coherus’ business, and the timing of Coherus’ regulatory filings; the risk of FDA review issues; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2023, filed with the Securities and Exchange Commission on August 2, 2023, including the section therein captioned “Risk Factors” and in other documents that Coherus files with the Securities and Exchange Commission.

UDENYCA®, CIMERLI®, YUSIMRY™ and ONBODY™, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners.

Coherus Contact Information:

For Investors:
Marek Ciszewski, J.D., SVP Investor Relations
[email protected]

For Media:
Jodi Sievers, VP Corporate Communications
[email protected] 



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Nature Wood Group Limited Announces Strategic Cooperation with the Research Institute of Wood Industry, Chinese Academy of Forestry, Launching Its Biomass Supramolecular New Materials Innovation Project

Macau, China, Sept. 25, 2023 (GLOBE NEWSWIRE) — Nature Wood Group Limited (the “Company” or “Nature Wood”) (Nasdaq: NWGL), a global leading vertically-integrated forestry company that focuses on FSC business operations, today announced its Chinese subsidiary Foshan City Linjia Technology Company Limited (“Linjia Tech”) has entered into a framework agreement (“Framework Agreement”) with the Research Institute of Wood Industry, Chinese Academy of Forestry (“Research Institute”) on September 22, 2023, pursuant to which Linjia Tech has formed a five-year innovative partnership with the Research Institute on the research and development in relation to biomass supramolecular and biomass carbon electrode new materials. This collaboration marks a significant stride towards advancing biomass carbon innovation, with both parties dedicated to propelling advancements in biomass supramolecular and biomass carbon electrode materials.

Under the Framework Agreement, the Research Institute will carry out research and development work according to the technological requirements put forward by Linjia Tech and promote the technological innovation of Linjia Tech on new biomass supramolecular materials. The Research Institute will offer to transfer to Linjia Tech in priority of any of its technological achievements relating to biomass carbon. The Research Institute will also provide technical service to Linjia Tech’s information exchange home and abroad on new biomass supramolecular materials, deploy experts to Linjia Tech for technical support and organize teachers and students to Linjia Tech to carry out scientific research practice activities, etc. Both parties will jointly participate in various scientific and technological projects promoted by the national or local governmental bodies and carry out exchanges and discussions on relevant policies, industry trends and market developments, etc. Both parties are committed to strengthening the innovative research work in the field of biomass supramolecular and biomass carbon electrode new materials to drive the development of sustainable batteries from renewable sources worldwide.

Mr. Se Hok Pan, Chairman of Nature Wood Group expressed enthusiasm about the collaboration and commented, “We are excited to establish this dynamic partnership with the Research Institute of Wood Industry, Chinese Academy of Forestry, and to initially embark on the development and innovative project in the biomass supramolecular materials industry. This collaboration strengthens our commitment to pioneering cutting-edge biomass supramolecular materials. We firmly believe that the biomass carbon battery industry represents the golden track of future development. Together with the Research Institute, we are well-positioned to lead innovation in this sector and contribute to a greener, more sustainable world.”

Mr. Feng Fu, Director of the Research Institute of Wood Industry, Chinese Academy of Forestry, emphasized the potential of the partnership, saying, “Our collaboration with Nature Wood Group Limited holds tremendous promise. Nature Wood brings exceptional research capabilities to the field of biomass supramolecular materials, complementing our expertise in biomass supramolecular materials. This partnership embodies a win-win opportunity, fostering accelerated growth in the biomass carbon industry and promoting a cleaner energy ecosystem.”

Biomass, sourced from renewable organic materials such as plants and animals, stores solar energy through photosynthesis. It can be used directly for heat or converted into liquid and gaseous fuels through various processes, making it one of the largest renewable sources of carbon globally.

About Nature Wood Group Limited

Nature Wood Group Limited is a global leading vertically-integrated forestry company that focuses on FSC business operations, timber and wood products industry. The Company’s operations cover both up-stream forest management and harvesting, and down-stream wood-processing and distribution. Nature Wood offers a broad line of products, including logs, decking, flooring, sawn timber, recycled charcoal, synthesized charcoal, machine-made charcoal and essential oils, primarily through its sales network in Europe, South Asia, South America, North America and China. For more information, please visit: www.nature-wood.com.

Safe Harbor Statement

This press release contains statements that may constitute “forward-looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to,” and similar statements. Statements that are not historical facts, including statements about the Company’s beliefs, plans, and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. Further information regarding these and other risks is included in the Company’s filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

For investor and media inquiries, please contact:

Janice Wang, Managing Partner
WFS Investor Relations Inc.
Phone: +86 13811768599 +1 628 283 9214
Email: [email protected]



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Wave Life Sciences to Present at the Chardan 7th Annual Genetic Medicines Conference

CAMBRIDGE, Mass., Sept. 25, 2023 (GLOBE NEWSWIRE) — Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage RNA medicines company committed to delivering life-changing treatments for people battling devastating diseases, today announced that Paul Bolno, MD, MBA, President and Chief Executive Officer, is scheduled to present at the Chardan 7th Annual Genetic Medicines Conference in New York City on Monday, October 2, 2023. Dr. Bolno will participate in the ADAR Editing Panel at 9:30 a.m. ET and an analyst-led fireside chat at 10:30 a.m. ET.

A live webcast of the fireside chat will be available on the Investor Relations page of the Wave Life Sciences website at http://ir.wavelifesciences.com. A replay of the ADAR Editing Panel will be available after the conclusion of the conference. Both replays will be archived and available on the site for a limited time following the event.

About Wave Life Sciences

Wave Life Sciences (Nasdaq: WVE) is a clinical-stage RNA medicines company committed to delivering life-changing treatments for people battling devastating diseases. Wave aspires to develop best-in-class medicines across multiple therapeutic modalities using PRISM, the company’s proprietary discovery and drug development platform that enables the precise design, optimization, and production of stereopure oligonucleotides. Driven by a resolute sense of urgency, the Wave team is targeting a broad range of genetically defined diseases so that patients and families may realize a brighter future. To find out more, please visit www.wavelifesciences.com and follow Wave on X (formerly Twitter) @WaveLifeSci.

Investor Contact:

Kate Rausch
+1 617-949-4827
[email protected]

Media Contact:

Alicia Suter
+1 617-949-4817
[email protected]



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TransCode Therapeutics Announces Positive Pre-Clinical Glioblastoma Results with Lead Therapeutic Candidate, TTX-MC138

Further Supports TTX-MC138 Application in Brain Cancer

BOSTON, Sept. 25, 2023 (GLOBE NEWSWIRE) — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, announced today positive results with its lead therapeutic candidate, TTX-MC138, in murine models bearing human glioblastoma multiforme (GBM) tumors. In this study, the therapeutic candidate was delivered to brain tumors and effectively engaged its target.

GBM is the most common and aggressive form of brain cancer. Its prognosis is poor despite advances in standard-of-care therapy. The 5-year survival rate has remained essentially unchanged over the past 30 years. TransCode believes there is an urgent need to develop more effective therapies. In the study reported by TransCode, mice implanted with tumors derived from human GBM patients were treated with TTX-MC138 and imaged by magnetic resonance imaging (MRI) to determine delivery of the therapeutic candidate to the tumors. In addition, the pharmacodynamic activity of TTX-MC138 was determined by measuring inhibition of the therapeutic target, miRNA-10b, using qRT-PCR. TTX-MC138 was injected intravenously and accumulated efficiently in the tumors. Importantly, the therapeutic candidate showed lasting activity and significantly inhibited miRNA-10b, known to be a driver of tumor progression in glioblastoma.

TTX-MC138 consists of an iron oxide nanocarrier conjugated to a nucleic acid designed to inhibit the oncogenic RNA, microRNA-10b. MiRNA-10b is described as the master regulator of cancer progression in a number of advanced solid tumors. TransCode believes that TTX-MC138 could be used as a treatment for many of these cancers. Administration of TTX-MC138 has resulted in complete regression of metastatic disease in numerous mouse models of pancreatic and breast cancer. In addition, TTX-MC138 was successfully delivered and demonstrated efficacy in spontaneous feline mammary carcinoma.

TransCode’s Chief Technology Officer, Zdravka Medarova, commented, “We believe that the latest data obtained in GBM further support the application of TTX-MC138 for the treatment of cancer. Given the lethal nature of this disease and the paucity of therapeutic options for patients with GBM, a therapeutic candidate with a novel mechanism of action, such as TTX-MC138, could have a dramatic impact on patient outcomes considering the evidence obtained to date of disease regressions by this therapeutic candidate in various cancers”.

“We believe that successful in vivo delivery of TTX-MC138 in GBM tumors derived from human tissue supports earlier evidence that therapeutic candidates using the TTX platform have the potential to accumulate in tumor tissue, engaging RNA targets beyond the liver”, added Michael Dudley, Chief Executive Officer of TransCode.

The study was led by Dr. Anna Moore, Professor and Director of the Precision Health Program at Michigan State University, and a scientific co-founder of TransCode. 

TransCode’s first-in-human clinical trial with TTX-MC138 is open for enrollment and has dosed it’ first patient. In this clinical trial, up to 12 patients will be given a single microdose of radiolabeled TTX-MC138 followed by noninvasive PET-MRI and other testing. The trial is intended to quantify the amount of TTX-MC138 delivered to metastatic lesions and the pharmacokinetics of the therapeutic candidate in cancer patients. The trial could yield important data regarding TTX-MC138 delivery to clinical metastases that could inform dose selection, dosing frequency, and patient selection to expedite the path to success in later stage clinical trials. This trial is not intended to evaluate therapeutic efficacy.

About TransCode Therapeutics

TransCode is an RNA oncology company created on the belief that cancer can be more effectively treated using RNA therapeutics. Using its iron oxide nanoparticle delivery platform, the Company has created a portfolio of drug candidates designed to target a variety of tumor types with the objective of significantly improving patient outcomes. The Company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which is believed to cause approximately 90% of all cancer deaths totaling over nine million per year worldwide. The Company believes that TTX-MC138 has the potential to dramatically improve clinical outcomes in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas, and others. Another of the Company’s drug candidates, TTX-siPDL1, focuses on treating tumors by targeting a protein called Programmed death-ligand 1 (PD-L1). TransCode also has three cancer-agnostic programs: TTX-RIGA, an RNA–based agonist of the retinoic acid-inducible gene I designed to drive an immune response in the tumor microenvironment; TTX-CRISPR, a CRISPR/Cas9–based therapy platform for the repair or elimination of cancer-causing genes inside tumor cells; and TTX-mRNA, an mRNA-based platform for the development of cancer vaccines designed to activate cytotoxic immune responses against tumor cells.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the results of preclinical studies of TTX-MC138 in breast cancer and other tumor types, statements concerning expected clinical results of TransCode’s therapeutic candidates, statements concerning the results of RNA research, statements concerning the potential for treating cancer with RNA therapeutics, statements concerning the timing and outcome of expected regulatory filings and clinical trials, including the first-in-human study of TTX-MC138, and whether this study will demonstrate proof-of-mechanism, and statements concerning TransCode’s portfolio of drug candidates and TTX technology platform generally. Of note, a Phase 0 clinical trial is an exploratory study, conducted under an exploratory Investigational New Drug (eIND) application. Exploratory IND studies usually involve very limited human exposure to a therapeutic candidate to evaluate mechanism of action to inform potential future clinical studies, but otherwise have no therapeutic intent. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk associated with drug discovery and development; the risk that the results of our planned clinical trials will not be consistent with our pre-clinical studies or expectations; risks associated with the timing and outcome of TransCode’s planned regulatory submissions; risks associated with TransCode’s planned clinical trials for its product candidates; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with TransCode’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risks associated with TransCode’s financial condition and its need to obtain additional funding to support its business activities, including TransCode’s ability to continue as a going concern; risks associated with TransCode’s dependence on third parties; and risks associated with the COVID-19 coronavirus. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause TransCode’s actual results to differ from those contained in or implied by the forward-looking statements, see the section entitled “Risk Factors” in TransCode’s Annual Report on Form 10-K for the year ended December 31, 2022, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release; TransCode undertakes no duty to update this information unless required by law.

For more information, please contact:

TransCode Therapeutics, Inc.
Alan Freidman, VP Investor Relations
[email protected]