Genmab to Hold 2025 R&D Update and ASH Data Review Meeting




Genmab to Hold 2025 R&D Update and ASH Data Review Meeting

Media Release

• Event to be held virtually via live webcast and archived on www.genmab.com

Copenhagen, Denmark; December 11, 2025 – Genmab A/S (Nasdaq: GMAB) will hold its 2025 R&D Update and ASH Data Review Meeting today, December 11, 2025 at 11:00 AM Eastern Time (5:00 PM CET / 4:00 PM GMT). The event will take place virtually and can be attended via live webcast. To register for the webcast, click https://genmab-post-ash-2025.open-exchange.net/registration. An archive of the webcast will be available on Genmab’s website.

This meeting is not an official program of the ASH Annual Meeting.

About Genmab 
Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines^®. 

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Contact:        
Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; HexaBody^®; DuoHexaBody^®, HexElect^® and KYSO^®.

Media Release no. i27
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark

Attachment

• 111225_i27_Post ASH Event

Aukera Therapeutics Comes Out of Stealth




Aukera Therapeutics Comes Out of Stealth

David Urech to join the board

BASEL, Switzerland, Dec. 11, 2025 (GLOBE NEWSWIRE) — Aukera Therapeutics, a preclinical-stage biotech spin-off from the University of Basel is officially coming out of stealth as it enters preclinical efficacy studies. It announced today that it has raised some CHF 4.5M to date and attracted new board member and investor David Urech. Other current investors include Kickfund and Zürcher Kantonalbank.

Aukera is focused on the therapy of neurological conditions associated with RAPTOR activity (regulatory-associated protein of mTOR). The company screened billions of compounds using AI-supported technology to discover a highly selective RAPTOR inhibitor modulating the mTORC1 signaling network – a new approach to selectively tackling a proven target with the potential for greater efficacy and favorable safety.

Aukera CEO and co-founder, Stefan Imseng, Ph.D., is pledging to pursue a therapy in Tuberous Sclerosis Complex (TSC), a rare multisystem genetic disorder.

“TSC typically starts in infancy and leads to seizures and a plethora of neuropsychiatric symptoms,” said Stefan, adding that mutations in TSC genes overactivate mTORC1 and lead to hyperexcitability of neurons in the brain. “Aukera’s RAPTOR inhibitors dampen mTORC1 activity, which is expected to result in reduced frequency and severity of seizures, offering relief for TSC patients, families and caregivers.”

The company plans to expand later to other indications with mTORC1 dysregulation, such as neurodegeneration, metabolic disorders, age-related diseases.

“The promise to change the lives of more than one million TSC patients, and the scientific excellence of the Aukera team, is why I decided to invest and join the board,” said David Urech, founder and former CEO of Numab Therapeutics whose subsidiary Yellow Jersey sold to J&J for $1.25 B in 2024.

About Aukera Therapeutics
Aukera Therapeutics is developing the first RAPTOR inhibitors for the treatment of mTORC1-related pathologies. The company is a spin-off from the Biozentrum of the University of Basel, founded on seminal academic research from the laboratories of Professors Michael N. Hall and Timm Maier. Aukera pairs mTOR expertise with an AI-driven drug discovery engine built for complex and hard-to-drug targets. The company’s lead program focuses on rare neurological disorders such as TSC. Future use of RAPTOR inhibitors include neurodegenerative, metabolic and age-related diseases. Aukera has received funding and support from Venture Kick, BaseLaunch, the Innovation Office of the University of Basel and Innosuisse.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0fa1d97a-8a6a-459d-8754-fc61e33c284f

Immunovant Announces Pricing of $550 Million Common Stock Financing




Immunovant Announces Pricing of $550 Million Common Stock Financing

• Funding to provide runway through potential Graves’ Disease commercial launch

NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) — Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced the pricing of an underwritten offering of its common stock, with anticipated gross proceeds to Immunovant of approximately $550 million, before deducting underwriting discounts and commissions and other expenses payable by Immunovant in connection with the transaction. Roivant Sciences Ltd., the Company’s controlling stockholder, has agreed to purchase shares in the offering. All of the shares are to be sold by Immunovant.

Immunovant currently expects that its existing cash and cash equivalents, together with the proceeds from the transaction, will be sufficient to fund its operating expenses and capital expenditures through the potential commercial launch of IMVT-1402 in the Graves’ Disease indication.

Immunovant offered 26.2 million shares of its common stock in the offering at an offering price of $21.00 per share. The offering is expected to close on or about December 12, 2025, subject to satisfaction of customary closing conditions.

Leerink Partners is acting as the sole underwriter for the offering.

The shares in the offering are being offered by Immunovant pursuant to an automatic registration statement on Form S-3 previously filed with the SEC.

When available, a copy of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@leerink.com.

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

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, but are not limited to, the uncertainties related to the completion of the offering. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402; Immunovant is at various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Annual Report on Form 10-K filed with the SEC on May 29, 2025, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:
Investors
Keyur Parekh
keyur.parekh@roivant.com

Media
Stephanie Lee
stephanie.lee@roivant.com

MediPharm Labs Announces Board of Directors Changes: Shelley Potts Steps Down, Michael Bumby Returns




MediPharm Labs Announces Board of Directors Changes: Shelley Potts Steps Down, Michael Bumby Returns

TORONTO, Dec. 10, 2025 (GLOBE NEWSWIRE) — MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) (“MediPharm” or the “Company”), a pharmaceutical company specialized in precision-based cannabinoids, today announced that Shelley Potts will be stepping down from the Company’s Board of Directors (the “Board”), effective December 31, 2025. The Company also announced that Michael Bumby will be rejoining the Board, effective January 1, 2026, bringing extensive experience in finance and governance to support MediPharm’s strategic priorities.

Michael Bumby previously served on the Board and was Chief Financial Officer at VIVO Cannabis Inc., which MediPharm acquired in 2023. In addition to his experience in the cannabis sector, Michael has held senior leadership roles in global pharmaceutical companies, providing strategic and financial oversight across highly regulated markets. His combined expertise in pharma and cannabis will support MediPharm Labs continued advancement in pharmaceutical cannabinoids.

Chris Taves, Chair of the Board, commented:

“On behalf of the Board and the entire MediPharm Labs team, I want to thank Shelley for her valuable contributions and leadership during her tenure. Shelley has been a Board member since 2020, and has helped guide the company’s stable growth through some of the cannabis industry’s early turbulent times. Shelley has been a strong voice for good corporate governance and thoughtful financial discipline throughout her tenure.”   

“We are also pleased to welcome Michael back to the Board. His financial expertise and prior experience with VIVO and MediPharm will provide additional valuable depth and perspective to the Board.”

About MediPharm Labs

Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research-driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities for delivery of pure, trusted and precision-dosed cannabis products for its customers. MediPharm Labs develops, formulates, processes, packages and distributes cannabis and advanced cannabinoid-based products to domestic and international medical markets.

In 2021, MediPharm Labs received a Pharmaceutical Drug Establishment License from Health Canada, becoming the only company in North America to hold a commercial-scale domestic Good Manufacturing Practices License for the extraction of multiple natural cannabinoids. This GMP license was the first step in the Company’s current foreign drug manufacturing site registration with the US FDA.

In 2023, MediPharm acquired VIVO Cannabis Inc. which expanded MediPharm’s reach to medical patients in Canada via Canna Farms medical ecommerce platform, and in Australia and Germany through Beacon Medical PTY and Beacon Medical GMBH. This acquisition also included Harvest Medical Clinics in Canada which provides medical cannabis patients with physician consultations for medical cannabis education and prescriptions.

The Company carries out its operations in compliance with all applicable laws in the countries in which it operates.

Cautionary Note Regarding Forward-Looking Information

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, Shelley Pott’s departure from the Board; Michael Bumby’s appointment to the Board, including the timing thereof; and statements regarding the Company’s advancement in pharmaceutical cannabinoids. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm’s continuous disclosure filings, available on the SEDAR+ website at www.sedarplus.ca. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.

SOURCE MediPharm Labs Corp.

For further information, please contact: MediPharm Labs Investor Relations,
1 416.913.7425, investors@medipharmlabs.com

Rhythm Pharmaceuticals to Announce Preliminary Data from Exploratory Phase 2 Trial Evaluating Setmelanotide in Prader-Willi Syndrome




Rhythm Pharmaceuticals to Announce Preliminary Data from Exploratory Phase 2 Trial Evaluating Setmelanotide in Prader-Willi Syndrome

BOSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast on Thursday, December 11 at 8:00 a.m. ET to disclose preliminary data from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).

Conference Call Information

Rhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET on Thursday, December 11 to discuss this update. Participants may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled start.

A webcast of the call will also be available under “Events and Presentations” in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for 30 days following the call.

About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

Setmelanotide Indication
In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS), POMC, PCSK1 or LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In Europe, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Limitations of Use
Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:

• Obesity due to suspected POMC, PCSK1 or LEPR deficiency with POMC, PCSK1 or LEPR variants classified as benign or likely benign.
• Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity.

Contraindication
Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized increased skin pigmentation and darkening of pre-existing nevi have occurred because of its pharmacologic effect. Full body skin examinations prior to initiation and periodically during treatment should be conducted to monitor pre-existing and new pigmentary lesions.

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Pediatric Population: The prescribing physician should periodically assess response to setmelanotide therapy. In growing children, the impact of weight loss on growth and maturation should be evaluated. In Europe, the prescribing physician should monitor growth (height and weight) using age- and sex-appropriate growth curves.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.

Please see the full U.S. Prescribing Information and EU Summary of Product Characteristics for additional Important Safety Information.

Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy of setmelanotide, RM-718 and other product candidates; clinical design, enrollment, or progress, and preliminary, interim and final data readouts; potential regulatory submissions, approvals and timing thereof of setmelanotide, RM-718 and other product candidates; the potential benefits of any of the Company’s products or product candidates for any specific disease indication or at any dosage, including the potential benefits of setmelanotide or RM-718 for patients with PWS, BBS or POMC, PCSK1, or LEPR deficiency; expectations surrounding pending and potential regulatory submissions and approvals, including within the United States, the EU and other regions; business strategy and plans, including regarding commercialization of setmelanotide in the United States, the EU and other regions; our participation in upcoming events and presentations; and the timing of any of the foregoing. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate qualified personnel, and general economic conditions, and the other important factors discussed under the caption “Risk Factors” in Rhythm’s Quarterly Report on Form 10-Q for the three months ended September 30, 2025 and other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
dconnolly@rhythmtx.com

Media Contact:
Layne Litsinger
Real Chemistry
llitsinger@realchemistry.com

Rhythm Pharmaceuticals to Announce Preliminary Data from Exploratory Phase 2 Trial Evaluating Setmelanotide in Prader-Willi Syndrome




Rhythm Pharmaceuticals to Announce Preliminary Data from Exploratory Phase 2 Trial Evaluating Setmelanotide in Prader-Willi Syndrome

BOSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast on Thursday, December 11 at 8:00 a.m. ET to disclose preliminary data from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).

Conference Call Information

Rhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET on Thursday, December 11 to discuss this update. Participants may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled start.

A webcast of the call will also be available under “Events and Presentations” in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for 30 days following the call.

About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

Setmelanotide Indication
In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS), POMC, PCSK1 or LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In Europe, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Limitations of Use
Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:

• Obesity due to suspected POMC, PCSK1 or LEPR deficiency with POMC, PCSK1 or LEPR variants classified as benign or likely benign.
• Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity.

Contraindication
Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized increased skin pigmentation and darkening of pre-existing nevi have occurred because of its pharmacologic effect. Full body skin examinations prior to initiation and periodically during treatment should be conducted to monitor pre-existing and new pigmentary lesions.

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Pediatric Population: The prescribing physician should periodically assess response to setmelanotide therapy. In growing children, the impact of weight loss on growth and maturation should be evaluated. In Europe, the prescribing physician should monitor growth (height and weight) using age- and sex-appropriate growth curves.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.

Please see the full U.S. Prescribing Information and EU Summary of Product Characteristics for additional Important Safety Information.

Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy of setmelanotide, RM-718 and other product candidates; clinical design, enrollment, or progress, and preliminary, interim and final data readouts; potential regulatory submissions, approvals and timing thereof of setmelanotide, RM-718 and other product candidates; the potential benefits of any of the Company’s products or product candidates for any specific disease indication or at any dosage, including the potential benefits of setmelanotide or RM-718 for patients with PWS, BBS or POMC, PCSK1, or LEPR deficiency; expectations surrounding pending and potential regulatory submissions and approvals, including within the United States, the EU and other regions; business strategy and plans, including regarding commercialization of setmelanotide in the United States, the EU and other regions; our participation in upcoming events and presentations; and the timing of any of the foregoing. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate qualified personnel, and general economic conditions, and the other important factors discussed under the caption “Risk Factors” in Rhythm’s Quarterly Report on Form 10-Q for the three months ended September 30, 2025 and other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
dconnolly@rhythmtx.com

Media Contact:
Layne Litsinger
Real Chemistry
llitsinger@realchemistry.com

Corbus Pharmaceuticals to Report Results from Phase 1a Study of Oral CB1 Inverse Agonist CRB-913 for the Treatment for Obesity on Thursday, December 11, 2025




Corbus Pharmaceuticals to Report Results from Phase 1a Study of Oral CB1 Inverse Agonist CRB-913 for the Treatment for Obesity on Thursday, December 11, 2025

Company will host conference call and live webcast to review and discuss the data at 8:00 am ET

NORWOOD, Mass., Dec. 10, 2025 (GLOBE NEWSWIRE) — Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical stage company focused on oncology and obesity, announced the Company’s plan to release results of its Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) study of CRB-913 prior to the market open on Thursday, December 11, 2025. Corbus will host a conference call and live webcast the same day at 8:00 am ET to review and discuss the Phase 1a data.

To register for the webcast, click here . A replay will be available on the Corbus website.

About CRB-913
CRB-913 is an oral small molecule inverse agonist of the G-protein Coupled Receptor (GPCR) cannabinoid type-1 (CB1). This is a recognized mechanism of action for weight loss, but the first generation of experimental drugs in this class was abandoned due to potential neuropsychiatric adverse event risks. CRB-913 is a highly peripherally restricted CB1 inverse agonist designed to have reduced brain penetration. Preclinical models have shown CRB-913 to be 15-fold less brain-penetrant than monlunabant (another experimental CB1 inverse agonist) and to have 50 times lower brain:plasma ratio than rimonabant (an extensively studied first-generation CB1 inverse agonist).

About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.

INVESTOR CONTACTS:

Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com

Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com

Corbus Pharmaceuticals to Report Results from Phase 1a Study of Oral CB1 Inverse Agonist CRB-913 for the Treatment for Obesity on Thursday, December 11, 2025




Corbus Pharmaceuticals to Report Results from Phase 1a Study of Oral CB1 Inverse Agonist CRB-913 for the Treatment for Obesity on Thursday, December 11, 2025

Company will host conference call and live webcast to review and discuss the data at 8:00 am ET

NORWOOD, Mass., Dec. 10, 2025 (GLOBE NEWSWIRE) — Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical stage company focused on oncology and obesity, announced the Company’s plan to release results of its Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) study of CRB-913 prior to the market open on Thursday, December 11, 2025. Corbus will host a conference call and live webcast the same day at 8:00 am ET to review and discuss the Phase 1a data.

To register for the webcast, click here . A replay will be available on the Corbus website.

About CRB-913
CRB-913 is an oral small molecule inverse agonist of the G-protein Coupled Receptor (GPCR) cannabinoid type-1 (CB1). This is a recognized mechanism of action for weight loss, but the first generation of experimental drugs in this class was abandoned due to potential neuropsychiatric adverse event risks. CRB-913 is a highly peripherally restricted CB1 inverse agonist designed to have reduced brain penetration. Preclinical models have shown CRB-913 to be 15-fold less brain-penetrant than monlunabant (another experimental CB1 inverse agonist) and to have 50 times lower brain:plasma ratio than rimonabant (an extensively studied first-generation CB1 inverse agonist).

About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.

INVESTOR CONTACTS:

Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com

Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com

MAIA Takes Aim at a $50B Immunotherapy Market with Breakthrough Telomere-Targeting Approach




MAIA Takes Aim at a $50B Immunotherapy Market with Breakthrough Telomere-Targeting Approach

CHICAGO, Dec. 10, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology (NYSE American: MAIA) – The treatment paradigm for advanced non-small cell lung cancer (NSCLC) is undergoing another shift. After a decade of targeted therapies and checkpoint inhibitors (CPIs) dominating headlines, MAIA believes that a new therapeutic class—telomere-targeting agents—is emerging for the population with substantial unmet medical need: patients without actionable mutations and who no longer respond to CPIs or chemotherapy.

This is a segment that existing therapies leave behind. And it is the segment where we believe that ateganosine, developed by MAIA, may soon become one of the most consequential entrants in years.

A Market Dominated by Checkpoint Inhibitors—But Vulnerable at Its Edges

CPI therapies remain the backbone of NSCLC treatment in patients who don’t have an actionable mutation. Collectively, the category generated approximately $50 billion in global sales in 2024, anchored by five major agents approved for NSCLC. The therapeutic concentration in lung cancer is striking:

• >30% of all NSCLC drug sales come from CPIs
• >40% of all CPI global sales originate from NSCLC alone

Merck’s Keytruda, the category-defining CPI, reported $29.5 billion in revenue in 2024, with NSCLC representing an estimated 30% of its total sales. Keytruda is expected to approach $35 billion by 2027—just before biosimilars begin entering the market in 2028.

While CPIs have transformed outcomes for some patients, in our opinion their limitations remain clear: patients without actionable mutations, and those who become CPI-refractory, still experience extremely poor prognosis and limited therapeutic benefit. We believe this treatment gap has become one of the industry’s largest unmet needs.

Telomere-Targeting: A New Pathway for a Hard-to-Treat Population

We believe that MAIA’s ateganosine represents the first drug in a new class. Unlike targeted therapies requiring EGFR, ALK, KRAS, or other mutations—and unlike immunotherapies dependent on PD-1/PD-L1 dynamics—ateganosine has been designed to exploit a universal feature of cancer cells: telomerase activity, present in more than 80% of human tumors.

Its dual mechanism has been designed to disrupt telomeres to trigger direct cancer cell death while simultaneously enabling the immune system to respond to cancer. MAIA was recently awarded Fast Track Designation by the U.S. FDA for the treatment of NSCLC in patients resistant to immunotherapy and chemotherapy, and is initiating a Phase 3 THIO-104 trial.

A Commercial Opportunity That Extends Across Oncology

With the NSCLC market now valued at $34.1 billion—projected to nearly double to $68.8 billion by 2033—the implications of a first-in-class therapy are substantial. In the United States alone, roughly 180,000 patients enter the NSCLC treatment ecosystem every year.

But ateganosine’s opportunity does not end with lung cancer. The candidate already carries FDA Orphan Drug Designations (ODDs) for:

• Glioblastoma (market: $2.2B → $3.2B growth expected)
• Hepatocellular carcinoma (HCC) (mortality: 0.8M; sales: $3.8B)
• Small cell lung cancer (SCLC) (mortality: 0.3M; sales: $2.8B)

Each ODD offers seven years of U.S. market exclusivity upon regulatory FDA approval and access to tax credits—advantages that strengthen MAIA’s long-term market positioning.

A Strategic Inflection Point for the Entire NSCLC Treatment Landscape

The oncology market is poised for a shift as developers seek to fill in gaps in the treatment landscape. The next decade is expected to reward novel mechanisms, and in our opinioin advanced NSCLC represents the clearest example of that gap.

Telomere-targeting therapeutics may be the next foundation in that evolution. If ateganosine’s outcomes are successful, the therapy could become a defining entrant in a space where treatment failure has long been accepted as inevitable. Statistical assessments points to a high probability of technical success for regulatory approval of ateganosine.

In our opinion, MAIA is now positioned at the center of this turning point—scientifically and strategically.

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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

MAIA Takes Aim at a $50B Immunotherapy Market with Breakthrough Telomere-Targeting Approach




MAIA Takes Aim at a $50B Immunotherapy Market with Breakthrough Telomere-Targeting Approach

CHICAGO, Dec. 10, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology (NYSE American: MAIA) – The treatment paradigm for advanced non-small cell lung cancer (NSCLC) is undergoing another shift. After a decade of targeted therapies and checkpoint inhibitors (CPIs) dominating headlines, MAIA believes that a new therapeutic class—telomere-targeting agents—is emerging for the population with substantial unmet medical need: patients without actionable mutations and who no longer respond to CPIs or chemotherapy.

This is a segment that existing therapies leave behind. And it is the segment where we believe that ateganosine, developed by MAIA, may soon become one of the most consequential entrants in years.

A Market Dominated by Checkpoint Inhibitors—But Vulnerable at Its Edges

CPI therapies remain the backbone of NSCLC treatment in patients who don’t have an actionable mutation. Collectively, the category generated approximately $50 billion in global sales in 2024, anchored by five major agents approved for NSCLC. The therapeutic concentration in lung cancer is striking:

• >30% of all NSCLC drug sales come from CPIs
• >40% of all CPI global sales originate from NSCLC alone

Merck’s Keytruda, the category-defining CPI, reported $29.5 billion in revenue in 2024, with NSCLC representing an estimated 30% of its total sales. Keytruda is expected to approach $35 billion by 2027—just before biosimilars begin entering the market in 2028.

While CPIs have transformed outcomes for some patients, in our opinion their limitations remain clear: patients without actionable mutations, and those who become CPI-refractory, still experience extremely poor prognosis and limited therapeutic benefit. We believe this treatment gap has become one of the industry’s largest unmet needs.

Telomere-Targeting: A New Pathway for a Hard-to-Treat Population

We believe that MAIA’s ateganosine represents the first drug in a new class. Unlike targeted therapies requiring EGFR, ALK, KRAS, or other mutations—and unlike immunotherapies dependent on PD-1/PD-L1 dynamics—ateganosine has been designed to exploit a universal feature of cancer cells: telomerase activity, present in more than 80% of human tumors.

Its dual mechanism has been designed to disrupt telomeres to trigger direct cancer cell death while simultaneously enabling the immune system to respond to cancer. MAIA was recently awarded Fast Track Designation by the U.S. FDA for the treatment of NSCLC in patients resistant to immunotherapy and chemotherapy, and is initiating a Phase 3 THIO-104 trial.

A Commercial Opportunity That Extends Across Oncology

With the NSCLC market now valued at $34.1 billion—projected to nearly double to $68.8 billion by 2033—the implications of a first-in-class therapy are substantial. In the United States alone, roughly 180,000 patients enter the NSCLC treatment ecosystem every year.

But ateganosine’s opportunity does not end with lung cancer. The candidate already carries FDA Orphan Drug Designations (ODDs) for:

• Glioblastoma (market: $2.2B → $3.2B growth expected)
• Hepatocellular carcinoma (HCC) (mortality: 0.8M; sales: $3.8B)
• Small cell lung cancer (SCLC) (mortality: 0.3M; sales: $2.8B)

Each ODD offers seven years of U.S. market exclusivity upon regulatory FDA approval and access to tax credits—advantages that strengthen MAIA’s long-term market positioning.

A Strategic Inflection Point for the Entire NSCLC Treatment Landscape

The oncology market is poised for a shift as developers seek to fill in gaps in the treatment landscape. The next decade is expected to reward novel mechanisms, and in our opinioin advanced NSCLC represents the clearest example of that gap.

Telomere-targeting therapeutics may be the next foundation in that evolution. If ateganosine’s outcomes are successful, the therapy could become a defining entrant in a space where treatment failure has long been accepted as inevitable. Statistical assessments points to a high probability of technical success for regulatory approval of ateganosine.

In our opinion, MAIA is now positioned at the center of this turning point—scientifically and strategically.

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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