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IRVINE, Calif., March 25, 2025 (GLOBE NEWSWIRE) — Beta Bionics, Inc. (Nasdaq: BBNX), a pioneering leader in the development of advanced diabetes management solutions, today reported its financial results for the quarter and year ended December 31, 2024 and introduced its annual guidance for the year ending December 31, 2025.

Fourth Quarter 2024 Financial Highlights & Key Metrics

• Net sales of $20.4 million, up 145% compared to $8.4 million in the fourth quarter of 2023.
  • Durable Medical Equipment (DME) channel net sales of $18.1 million, up 127% compared to $7.9 million in the fourth quarter of 2023.
  • Pharmacy Benefit Plan (PBP) channel net sales of $2.4 million, up 491% compared to $0.4 million in the fourth quarter of 2023.
• Gross margin of 57.2%, down 344 basis points compared to 60.6% in the fourth quarter of 2023.
• Installed customer base (calculated as all new patient starts over a rolling four-year period) of 15,298 users, up 564% compared to 2,304 in the fourth quarter of 2023.
• 4,084 new patient starts, up 125% compared to 1,818 new patient starts in the fourth quarter of 2023.
  • 70% of new patient starts came from multiple daily injections (MDI).
  • Low-teens percentage of new patient starts reimbursed through the PBP channel.

Full Year 2024 Financial Highlights & Key Metrics

• Net sales of $65.1 million, up 443% compared to $12.0 million in the prior year.
  • DME channel net sales of $58.8 million, up 422% compared to $11.3 million in the prior year.
  • PBP channel net sales of $6.3 million, up 760% compared to $0.7 million in the prior year.
• Gross margin of 55.1%, up 252 basis points compared to 52.6% in the prior year.
• 12,994 new patient starts, up 464% compared to 2,304 new patient starts in the prior year.
  • 69% of new patient starts came from MDI.
  • High-single digit percentage of new patient starts reimbursed through the PBP channel.

Recent Strategic Highlights

• Completed initial public offering and concurrent private placement, raising approximately $206.0 million in net proceeds to the company.
• Launched the Color iLet Bionic Pancreas, with a color screen and brighter display, for new commercial patients.
• Announced the first-to-market integration of the iLet Bionic Pancreas with Abbott’s FreeStyle Libre^® 3 Plus sensor in the United States.
• Released the Bionic Circle mobile application, a remote monitoring experience for users and caregivers, for iOS and Android devices.
• Announced that effective February 1, 2025, Prime Therapeutics has added the iLet Bionic Pancreas and associated monthly supplies to its largest national commercial formulary.
  • Beta Bionics is actively working with the health plans that partner with Prime Therapeutics to drive coverage of iLet under their pharmacy benefit, per Prime’s recommendation to the health plans.
  • For plans that cover the iLet Bionic Pancreas under their pharmacy benefit, this decision significantly reduces the potentially large up-front cost of the pump for both the patient and the plan, while easing the administrative burden for the physician when prescribing the iLet Bionic Pancreas.
• Successful completion and delivery by Xeris Pharmaceuticals of a pump-compatible formulation of glucagon utilizing XeriSol technology for use in Beta Bionics’ bihormonal pump and pump systems.
  • Beta Bionics completed pump compatibility testing and released a one-time $3.0 million milestone payment to Xeris Pharmaceuticals under our exclusive collaboration and license agreement.

“2024 was a tremendous momentum-building year for Beta Bionics. We ended the year with over 15,000 users in our install base, released our first year of real-world evidence for the iLet, progressed in our efforts to secure pharmacy channel coverage and reimbursement for the iLet and associated monthly supplies, and advanced our patch and bihormonal pipeline programs including our entry into an exclusive collaboration and licensing agreement with Xeris Pharmaceuticals for glucagon,” said Sean Saint, Beta Bionics’ President and CEO. “As we enter 2025 as a newly public company, we look forward to building on our momentum as we continue to expand iLet’s reach and advance our exciting pipeline programs.”

2025 Full Year Guidance

• Estimated total revenue of approximately $80 million to $85 million
• Estimated greater than 20% of new patient starts reimbursed through the PBP channel
• Estimated gross margin of at least 50%

Fourth Quarter 2024 Additional Financial Results

• Loss from operations of $13.0 million, or negative 64% of sales, compared to $8.4 million or negative 100% of sales in the fourth quarter of 2023.
• Net loss of $18.1 million, or negative 89% of sales, compared to $18.8 million or negative 226% of sales in the fourth quarter of 2023.
• Adjusted EBITDA⁽¹⁾ of negative $11.3 million, or negative 55% of sales, compared to negative $6.6 million or negative 78% of sales in the fourth quarter of 2023.
• $103.6 million in cash, cash equivalents, and short-term investments as of December 31, 2024. The company received approximately $206.0 million in net proceeds from its initial public offering and concurrent private placement, which closed on January 31, 2025.

Full Year 2024 Additional Financial Results

• Loss from operations of $45.3 million, or negative 69% of sales, compared to $35.9 million or negative 299% of sales in the prior year.
• Net loss of $54.8 million, or negative 84% of sales, compared to $44.1 million or negative 368% of sales in the prior year.
• Adjusted EBITDA⁽¹⁾ of negative $37.7 million, or negative 58% of sales, compared to negative $29.0 million or negative 242% of sales in the prior year.

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) See “Non-GAAP Financial Measures” below for additional information. A reconciliation of the non-GAAP financial measure to its most directly comparable GAAP financial measure can be found in Table E.

Webcast & Conference Call Details

Beta Bionics will host a conference call and concurrent webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time), to review the company’s fourth quarter and full year 2024 performance. The link to the webcast will be available on the Company’s website in the “Investors—Events & Presentations” section at https://investors.betabionics.com, and will be archived there for future replay. To access the live call by phone, please use the following link, which will provide you with dial-in details and a personal pin: https://register-conf.media-server.com/register/BI8be51a4e688845529dd55d442f427c91.

Non-GAAP Financial Measures

Beta Bionics, Inc. (the “Company”) prepares and presents the Company’s financial statements in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). The Company believes adjusted EBITDA as a non-GAAP measure is useful in evaluating the Company’s operating performance and uses adjusted EBITDA to evaluate ongoing operations and for internal planning and forecasting purposes. The Company believes that this non-GAAP financial measure, when taken together with the corresponding GAAP financial measures, provide meaningful supplemental information regarding the Company’s performance by excluding certain items that may not be indicative of the Company’s business, results of operations, or outlook. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. In addition, other companies, including companies in the Company’s industry, may calculate similarly-titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of the Company’s non-GAAP financial measures as tools for comparison. A reconciliation is provided below for adjusted EBITDA to the most directly comparable financial measure stated in accordance with GAAP in Table E below.

The Company calculates adjusted EBITDA as net loss adjusted to exclude (i) depreciation and amortization expense, (ii) stock-based compensation expense, (iii) interest income, (iv) provision for state taxes and (v) change in fair value of warrant liabilities.

Some of the limitations of adjusted EBITDA include: (i) adjusted EBITDA does not properly reflect capital commitments to be paid in the future and (ii) although depreciation and amortization expense are non-cash charges, the underlying assets may need to be replaced and adjusted EBITDA does not reflect these capital expenditures. The Company’s adjusted EBITDA may not be comparable to similarly titled measures of other companies because they may not calculate adjusted EBITDA in the same manner as the Company calculates the measure, limiting its usefulness as a comparative measure. In evaluating adjusted EBITDA, you should be aware that in the future the Company will incur expenses similar to the adjustments in this presentation. The Company’s presentation of adjusted EBITDA should not be construed as an inference that the Company’s future results will be unaffected by these expenses or any unusual or non-recurring items. When evaluating the Company’s performance, you should consider adjusted EBITDA alongside other financial performance measures, including the Company’s net loss and other GAAP results.

Investors are encouraged to review the related GAAP financial measures and the reconciliation of this non-GAAP financial measure to its most directly comparable GAAP financial measure, and not to rely on any single financial measure to evaluate the Company’s business. This non-GAAP measure has limitations as an analytical tool and should not be construed as an inference that the Company’s future results will be unaffected by unusual or non-recurring items. Therefore, this non-GAAP financial measure should be considered in addition to, not as a substitute for, or in isolation from, measures prepared in accordance with GAAP.

About Beta Bionics

Beta Bionics, Inc. is a commercial-stage medical device company engaged in the design, development, and commercialization of innovative solutions to improve the health and quality of life of insulin-requiring people with diabetes (PWD) by utilizing advanced adaptive closed-loop algorithms to simplify and improve the treatment of their disease. The iLet Bionic Pancreas is the first FDA-cleared insulin delivery device that autonomously determines every insulin dose and offers the potential to substantially improve overall outcomes across broad populations of PWD. To learn more, visit www.betabionics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Beta Bionics, Inc. (the “Company”) regarding our regulatory development plans for the iLet and other product candidates; the markets and market opportunities for the iLet and other product candidates, if approved; the timing, likelihood or success of our business strategy, including commercialization and our multi-channel reimbursement strategy, as well as plans and objectives of management for future operations; our anticipated growth and other measures of future operating results and financial performance, including 2025 full year guidance regarding revenue, new patient starts through the PBP channel and gross margin; and the potential benefits of the addition of the iLet to Prime Therapeutics’ national commercial formulary. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties, including business, regulatory, economic and competitive risks and uncertainties about the Company, including, without limitation, risks inherent in developing product candidates, future results from the Company’s ongoing and future studies and clinical trials, the Company’s ability to obtain adequate financing to fund its product development and other expenses, risks that real-world data or future results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials, trends in the industry, the Company’s relationships with its existing and future collaboration partners, the legal and regulatory framework for the industry, future expenditures and the potential impacts of global macroeconomic conditions. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. Other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission, including the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations:

Blake Beber
Head of Investor Relations
[email protected]

Media and Public Relations:

Karen Hynes
Vice President of Marketing
[email protected]

Source: Beta Bionics, Inc.

DURHAM, N.C., March 25, 2025 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it has commenced an underwritten public offering of its common stock. In addition, Humacyte intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering. All of the shares are being offered by Humacyte.

TD Cowen, Barclays and BTIG are acting as joint book-running managers for the offering. H.C. Wainwright & Co. and The Benchmark Company are acting as lead managers for the offering. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Humacyte intends to use the net proceeds that it will receive from the offering to fund the commercialization of SYMVESS™ in the vascular trauma indication, the development of the product candidates in Humacyte’s pipeline and for working capital and general corporate purposes.

A shelf registration statement on Form S-3 (No. 333-267225) was previously filed with the Securities and Exchange Commission (the “SEC”) on September 1, 2022 and declared effective by the SEC on September 9, 2022. The securities will be offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, by telephone at (833) 297-2926, or by email at [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (888) 603-5847, or by email at [email protected]; or BTIG, LLC, 65 East 55th Street, New York, New York 10022, by telephone at (212) 593-7555 or by email at [email protected].

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

About Humacyte

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. Humacyte develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of acellular tissue engineered vessels (“ATEVs”), are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (“AV”) access for hemodialysis, and peripheral artery disease (“PAD”). A Biologics License Application for the ATEV in the vascular trauma indication was approved by the U.S. Food and Drug Administration (“FDA”) in December 2024. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (“RMAT”) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense.

For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Forward-Looking Statements

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although Humacyte believes that it has a reasonable basis for each forward-looking statement contained in this press release, Humacyte cautions you that these statements are based on a combination of facts and factors currently known by it and its projections of the future, about which Humacyte cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the timing and success of the proposed offering; whether Humacyte will be able to raise capital through the sale of shares of common stock in the offering; the anticipated use of proceeds from the proposed offering; Humacyte’s plans and ability to commercialize its ATEV in the United States under the brand name SYMVESS in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of Humacyte’s preclinical and clinical trials; the anticipated characteristics and performance of its ATEVs; Humacyte’s ability to successfully complete, preclinical and clinical trials for its ATEVs; the anticipated benefits of the ATEV relative to existing alternatives; the anticipated commercialization of the ATEVs and Humacyte’s ability to manufacture at commercial scale; the implementation of Humacyte’s business model and strategic plans for its business; and the timing or likelihood of regulatory filings, acceptances and approvals. Humacyte cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in Humacyte’s Annual Report on Form 10-K for the year ended December 31, 2023, Humacyte’s quarterly report on Form 10-Q for the quarter ended September 30, 2024, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by Humacyte or any other person that Humacyte will achieve its objectives and plans in any specified time frame, or at all. Except as required by law, Humacyte has no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing Humacyte’s views as of any date subsequent to the date of this press release.

Humacyte Investor Contact:

Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
[email protected]
[email protected]

Humacyte Media Contact:

Rich Luchette
Precision Strategies
+1-202-845-3924
[email protected]
media@humacyte

BELGRADE, Mont. and BLAGNAC, France, March 25, 2025 (GLOBE NEWSWIRE) — Bridger Aerospace Group Holdings, Inc. (“Bridger” or “Bridger Aerospace”) (NASDAQ: BAER, BAERW), one of the nation’s largest aerial firefighting companies, and Positive Aviation, Inc. (“PA”), a Blagnac, France-based engineering company, announced today that they have entered into a Memorandum of Understanding (“MOU”) designating Bridger as the exclusive North American launch customer for PA’s FF72 aircraft, a state-of-the-art, reliable, and efficient amphibious water-scooping firefighting aircraft derived from an ATR 72-600. The partnership was officially unveiled today at the Aerial Fire Fighting Series: Europe Conference and Exhibition (“AFFE25”) held at the Centre de Congrès Cité Mondiale in Bordeaux, France, and remains subject to negotiation of a definitive collaboration agreement between the parties on terms consistent with the MOU.

Under the terms of the MOU, Bridger will serve as the exclusive North American hub for the sales, marketing, in-service support, modifications, certification, and flight crew and mechanics training for the FF72 aircraft. Additionally, the MOU provides Bridger with the opportunity to purchase ten FF72 aircraft, with an option to acquire an additional ten units at a later date, subject to mutually agreed-upon terms and conditions. PA has indicated that they expect to begin deliveries of the FF72 to Bridger in time for the 2029 fire year.

This framework agreement marks an exciting expansion opportunity of Bridger’s fleet, complementing its existing fleet of CL-415 EAF Super Scoopers. The addition of the FF72 will integrate disruptive new technology, further enhancing Bridger’s ability to respond to wildfires with cutting-edge, cost-effective aerial firefighting assets. By incorporating the FF72 in its fleet, Bridger aims to solidify its position as a leader in the aerial firefighting industry, continually innovating and expanding its capabilities to meet the evolving needs of wildfire management.

“Bridger is the leading aerial firefighting company in North America and has long been recognized for its expertise in deploying, training, and providing aerial firefighting services to communities affected by wildfires,” said Laurent Schmitt, Chairman and Founder of PA. “We are proud to partner with Bridger and are excited to develop this aircraft to meet the growing demand for cost-effective wildfire fighting solutions both in the U.S. and globally.”

Sam Davis, Chief Executive Officer of Bridger, stated, “With the increasing global demand for year-round aerial firefighting resources and the current shortage of available assets, the FF72 will be a valuable addition to our Scooper fleet. By combining advanced airframe enhancements with the aircraft’s proven technologies and reliability, Positive Aviation has developed an outstanding product. We look forward to working together to introduce these assets and support the wildfire-fighting community in addressing the ongoing, and increasingly year-round, challenge of wildfires.”

About Bridger Aerospace

Based in Belgrade, Montana, Bridger Aerospace Group Holdings, Inc. is one of the nation’s largest aerial firefighting companies. Bridger provides aerial firefighting and wildfire management services to federal and state government agencies, including the United States Forest Service, across the nation, as well as internationally. More information about Bridger Aerospace is available at https://www.bridgeraerospace.com.

About Positive Aviation

Bases in Blagnac, France, Positive Aviation is an engineering and industrial company, developing and implementing modifications on second-hand ATR 72 transforming them into amphibious water scooper firefighter aircraft – the FF72. The FF72 leverages proven technologies and combines expertise from both the aeronautical and naval industries.

Forward Looking Statements 

Certain statements included in this press release are not historical facts but are forward-looking statements, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “project,” “forecast,” “predict,” “poised,” “positioned,” “potential,” “seem,” “seek,” “future,” “outlook,” “target,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, (1) the anticipated benefits from Bridger’s proposed partnership with PA, including the expansion of Bridger’s operations and expected timing for deliveries of the ATR-FF72 aircraft to Bridger; (2) Bridger’s business and growth plans; (3) Bridger’s future financial performance; (4) current and future demand for aerial firefighting services, including trends and/or changes in the duration or severity of any domestic or international wildfire seasons; and (5) anticipated investments in additional aircraft, capital resources, and research and development and the effect of these investments. These statements are based on various assumptions and estimates, whether or not identified in this press release, and on the current expectations of Bridger’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Bridger. These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to: the ability of Bridger and PA to successfully negotiate and enter into a definitive collaboration agreement on terms consistent with the non-binding MOU; Bridger’s ability to identify and effectively implement any current or future anticipated cost reductions, including any resulting impacts to Bridger’s business and operations therefrom; the duration or severity of any domestic or international wildfire seasons; changes in domestic and foreign business, market, financial, political and legal conditions; Bridger’s failure to realize the anticipated benefits of any acquisitions; Bridger’s successful integration of any aircraft (including achievement of synergies and cost reductions); Bridger’s ability to successfully and timely develop, sell and expand its services, and otherwise implement its growth strategy; risks relating to Bridger’s operations and business, including information technology and cybersecurity risks, loss of requisite licenses, flight safety risks, loss of key customers and deterioration in relationships between Bridger and its employees; risks related to increased competition; risks relating to potential disruption of current plans, operations and infrastructure of Bridger, including as a result of the consummation of any acquisition; risks that Bridger is unable to secure or protect its intellectual property; risks that Bridger experiences difficulties managing its growth and expanding operations; Bridger’s ability to compete with existing or new companies that could cause downward pressure on prices, fewer customer orders, reduced margins, the inability to take advantage of new business opportunities, and the loss of market share; the ability to successfully select, execute or integrate future acquisitions into Bridger’s business, which could result in material adverse effects to operations and financial conditions; and those factors discussed in the sections entitled “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” included in Bridger’s Annual Report filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 14, 2025 for the fiscal year ended December 31, 2024 and in subsequent filings made by Bridger with the SEC from time to time. If any of these risks materialize or Bridger management’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. The risks and uncertainties above are not exhaustive, and there may be additional risks that Bridger presently does not know or that Bridger currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Bridger’s expectations, plans or forecasts of future events and views as of the date of this press release. Bridger anticipates that subsequent events and developments will cause Bridger’s assessments to change. However, while Bridger may elect to update these forward-looking statements at some point in the future, Bridger specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Bridger’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements contained in this press release.

DALLAS, March 25, 2025 (GLOBE NEWSWIRE) — Capital Southwest Corporation (“Capital Southwest,” or the “Company”) (Nasdaq: CSWC), an internally managed business development company focused on providing flexible financing solutions to support the acquisition and growth of middle market businesses, today announced that Moody’s Investors Service, Inc. (“Moody’s”) has affirmed Capital Southwest’s investment grade long-term issuer rating of Baa3 with a stable outlook. Factors cited by Moody’s in support of its rating include Capital Southwest’s strong capitalization and diverse funding profile, first-lien oriented investment portfolio, recurring earnings generation, and internally managed structure.

About Capital Southwest

Capital Southwest Corporation (Nasdaq: CSWC) is a Dallas, Texas-based, internally managed business development company with approximately $1.7 billion in investments at fair value as of December 31, 2024. Capital Southwest is a middle market lending firm focused on supporting the acquisition and growth of middle market businesses with $5 million to $50 million investments across the capital structure, including first lien, second lien and non-control equity co-investments. As a public company with a permanent capital base, Capital Southwest has the flexibility to be creative in its financing solutions and to invest to support the growth of its portfolio companies over long periods of time.

Forward-Looking Statements

This press release contains historical information and forward-looking statements with respect to the business and investments of Capital Southwest, including, but not limited to, the statements about Capital Southwest’s future performance and financial performance and financial condition. Forward-looking statements are statements that are not historical statements and can often be identified by words such as “will,” “believe,” “expect” and similar expressions and variations or negatives of these words. These statements are based on management’s current expectations, assumptions and beliefs. They are not guarantees of future results and are subject to numerous risks, uncertainties and assumptions that could cause actual results to differ materially from those expressed in any forward-looking statement. These risks include risks related to: changes in the markets in which Capital Southwest invests; changes in the financial, capital, and lending markets; changes in the interest rate environment and its impact on our business and our portfolio companies; regulatory changes; tax treatment; an economic downturn and its impact on the ability of our portfolio companies to operate and the investment opportunities available to us; the impact of supply chain constraints and labor shortages on our portfolio companies; and the elevated levels of inflation and its impact on our portfolio companies and the industries in which we invests.

Readers should not place undue reliance on any forward-looking statements and are encouraged to review Capital Southwest’s Annual Report on Form 10-K for the year ended March 31, 2024 and any subsequent filings with the SEC, including the “Risk Factors” sections therein, for a more complete discussion of the risks and other factors that could affect any forward-looking statements. Except as required by the federal securities laws, Capital Southwest does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changing circumstances or any other reason after the date of this press release.

Investor Relations Contact:

Michael S. Sarner, President and Chief Executive Officer
214-884-3829

Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Data From Cohorts 1-3 anticipated to be Presented in May

Initial Results From First Two Cohorts Supports Safety and Efficacy with Oral Agent and Novel Mechanism of Action

Registration Phase 3 Clinical Trial of Soquelitinib in Peripheral T Cell Lymphoma (PTCL) Enrolling with Multiple Clinical Sites Open

Conference call today at 4:30 p.m. ET / 1:30 p.m. PT

SOUTH SAN FRANCISCO, Calif., March 25, 2025 (GLOBE NEWSWIRE) — Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2024.

“We continue to advance our selective ITK inhibitor, soquelitinib, in a range of diseases,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “Our Phase 1 clinical trial in atopic dermatitis is nearing completion of enrollment in the third cohort at a dose level that we anticipate may be optimum based on our experience in T cell lymphomas. The results from the first two cohorts demonstrated safety and activity compared to placebo utilizing the rigorous endpoint of EASI 75 and IGA 0 or 1. Our Phase 3 registration clinical trial in peripheral T cell lymphoma (PTCL) is enrolling at multiple sites and we have recently initiated a Phase 2 trial in autoimmune lymphoproliferative syndrome (ALPS), a rare life-threatening genetic disease with multiple autoimmune manifestations. Our clinical strategy is to demonstrate the value of soquelitinib’s novel mechanism of action in both cancers and immune diseases, across multiple disease indications. This includes our planned solid tumor clinical trial, which we now anticipate initiating in the third quarter 2025.”

Business Update and Strategy

Soquelitinib (Corvus’ selective ITK inhibitor)

Soquelitinib for Immune Diseases

• On January 13, 2025, Corvus reported interim results from the first two cohorts of its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis that demonstrated a favorable safety profile and efficacy profile. This includes significant responses in the soquelitinib treatment groups compared to placebo for clinically significant endpoints of IGA (Investigator Global Assessment) 0 or 1 and EASI (Eczema Area and Severity Index) 75. Specifically, the Company reported results from 16 patients in Cohort 1 (12 patients in the soquelitinib group receiving 100 mg orally twice per day vs. four receiving placebo) and 10 patients in Cohort 2 (seven patients in the soquelitinib group receiving 200 mg orally once per day vs. three receiving placebo) for which 28 days of treatment had been completed. For those 19 patients in the soquelitinib group, 26% achieved IGA 0 or 1 and 37% achieved EASI 75; and of the seven in the placebo group, none achieved IGA 0 or 1 or EASI 75. No significant safety issues were observed and no clinically significant laboratory abnormalities were seen.
• Corvus is nearing completion of patient enrollment in the third cohort (200 mg orally twice per day) of the trial and plans to announce additional results from the study including data from Cohorts 1, 2 and 3 in May 2025.
• The atopic dermatitis Phase 1 clinical trial is enrolling patients with moderate to severe atopic dermatitis that previously failed at least one prior topical or systemic therapy. Enrollment in the first two cohorts is complete, and the third cohort is near completion of enrollment. Each cohort covers a 28-day dosing regimen and includes 12 patients that receive soquelitinib and 4 patients that receive placebo, for a total of 16 patients in each cohort. Patients are followed for an additional 30 days after completing the 28-day course of therapy. The endpoints include safety and improvement in the Eczema Area and Severity Index (EASI) and Investigator Global Assessment (IGA). Patients and physicians are blinded to the treatment assignment.
• The Company also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation that is optimized for specific immunology indications.

Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

• In March, the Company initiated a Phase 2 clinical trial in patients with ALPS under a clinical research and development agreement with NIAID. The Phase 2 clinical trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing. Two dosing cohorts will be studied. The patients will receive soquelitinib doses of 200 mg or 400 mg twice per day for a period of up to 360 days. The primary endpoint of the trial is efficacy determined by reductions in splenomegaly (enlarged spleen) and lymph node volumes as measured by computed tomography (CT). Improvements in cytopenias will be assessed by complete blood count (CBC). Cytopenias are caused by autoantibodies (antibodies that target the body’s own cells) that may lead to destruction of red blood cells, platelets and/or neutrophils leading to anemia, thrombocytopenia or neutropenia. Improvements in cytopenias can improve quality of life and overall health, and they also serve as a valuable biomarker associated with ALPS disease activity. Secondary endpoints include safety and tolerability.

Soquelitinib for T Cell Lymphoma

• Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory peripheral T cell lymphoma after at least 2 lines of systemic therapy.
• In March, additional data from the Phase 1/1b clinical trial of soquelitinib for patients with T cell lymphoma that continued to demonstrate strong indications of anti-tumor activity was presented at the 16^th Annual T-Cell Lymphoma Forum.
• Data supporting the potential of soquelitinib as a novel approach to modulate tumor immunity was published in npj Drug Discovery (part of the Nature portfolio of journals), an open access, international, peer-reviewed journal dedicated to publishing the highest quality research relevant to all aspects of drug design and discovery.

Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor)

• Corvus is collaborating with the Kidney Cancer Research Consortium (KCRC) in a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The efficacy endpoint for the trial is deep response rate, defined as CR plus PRs of greater than 50% tumor volume reduction. The trial is now fully enrolled (n=60) and patients are being followed.
• The Phase 1b/2 clinical trial in patients with metastatic RCC is supported by data presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting highlighting the potential of ciforadenant to overcome immunotherapy resistance in metastatic castration resistant prostate cancer. The data was presented in an oral session and was selected as a top 100 abstract. This work was recently published in January in the journal Nature 637:1207, 2025.

Partner Led Program: Mupadolimab (anti-CD73)

• Angel Pharmaceuticals, Corvus’ partner in China, continues to monitor patients in an expansion cohort of its Phase 1/1b clinical trial of mupadolimab in patients with relapsed non-small cell lung cancer (NSCLC).

Financial Results

As of December 31, 2024, Corvus had cash, cash equivalents and marketable securities of $52.0 million as compared to $27.1 million as of December 31, 2023. During the year ended December 31, 2024, the Company completed a registered direct offering in which it sold shares of common stock, pre-funded warrants and common warrants, generating $30.3 million in net proceeds. During the quarter ended December 31, 2024, two holders of 5,311,198 common stock warrants early exercised all of their warrants in advance of the June 30, 2025 expiration date, resulting in cash proceeds to the Company of approximately $18.6 million. Based on its current plans, Corvus expects its cash to fund operations into the first quarter of 2026.

Research and development expenses for the three months and full year ended December 31, 2024 totaled $6.0 million and $19.4 million, respectively, compared to $4.0 million and $16.5 million for the same periods in 2023. For the full year 2024, the increase of approximately $2.9 million was primarily due to higher clinical trial costs associated with the development of soquelitinib.

The net loss for the three months ended December 31, 2024 was $12.1 million compared to a net loss of $6.7 million for the same period in 2023. Total stock compensation expense for the three months ended December 31, 2024 was $0.8 million compared to $0.6 million for the same period in 2023 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $2.2 million for the three months ended December 31, 2024 compared to a loss of $1.4 million for the same period in 2023. In addition, the Company recorded a non-cash loss of $2.3 million related to an increase in the fair value of its warrant liability during the three months ended December 31, 2024. The Company issued approximately 17.1 million common stock warrants in its May 2024 registered direct offering with an exercise price of $3.50 per common stock warrant. After the early exercise of 5,311,198 common warrants during the three months ended December 31, 2024, 11,778,238 common stock warrants remain outstanding. The common stock warrants expire on June 30, 2025.

Conference Call Details

Corvus will host a conference call and webcast today, Tuesday, March 25, 2025, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2024 financial results. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

About Corvus Pharmaceuticals

Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com.

About Soquelitinib

Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation which has the potential to suppress autoimmune and inflammatory reactions. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company has initiated a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also now being investigated in a randomized placebo-controlled phase 1 clinical trial in patients with atopic dermatitis. A recent publication describing the chemistry, enzymology and biology of soquelitinib appeared in npj Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website.

About Peripheral T Cell Lymphoma

Peripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. First line treatment for these diseases is typically combination chemotherapy; however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the three to four month range and overall median survival of six to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials.

PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype.

About Atopic Dermatitis

Atopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma. Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical studies to inhibit cytokine production from Th2 lymphocytes.

About Autoimmune Lymphoproliferative Syndrome (ALPS)

ALPS is a rare genetic disease affecting children that manifests with lymphadenopathy, splenomegaly, cytopenias (low blood counts), proteinuria and autoimmunity. The disease is caused by a mutation in the Fas gene, which provides instructions for making a signaling protein involved in the induction of apoptosis. The mutation results in immune dysregulation due to abnormally high levels of “double negative” T cells (CD4 and CD8 double negative), which infiltrate the blood, spleen and lymphoid tissues. Fas signaling is regulated by ITK and T cell receptor signaling and patients with ALPS have an imbalance in this regulation resulting in a failure of T cells to undergo apoptosis and an accumulation of abnormal T cells.

About Ciforadenant

Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine to immune cells present in the tumor microenvironment. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2a receptor present on immune cells and block their activity. Ciforadenant has been shown to block the immunosuppressive effects of myeloid cells present in tumors and preclinical studies published in 2018 demonstrated synergy with combinations of anti PD1 and anti-CTLA4 antibodies.

About Mupadolimab

Mupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. Unlike certain other anti-CD73 antibodies and small molecules in development for treatment of cancer, which react with a different region of CD73, Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes.

About Angel Pharmaceuticals

Angel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with Corvus and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – soquelitinib, ciforadenant and mupadolimab – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a 49.7% equity stake in Angel Pharmaceuticals excluding 7% of Angel’s equity reserved for issuance under the Angel ESOP, and Corvus has designated three individuals on Angel’s five-person Board of Directors. For more information, visit www.angelpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates; the potential use of soquelitinib to treat a variety of hematological cancers and autoimmune diseases; the potential of ciforadenant to overcome immunotherapy resistance in metastatic castration resistant prostate cancer; the potential of ITK inhibition to provide a new oral treatment option for atopic dermatitis; the Company’s ability and its partners’ ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, as well as the timing thereof; clinical strategy and the design of clinical trials, including the timeline for initiation, target or expected number of patients to be enrolled, dose levels, expected number of sites and other product development milestones; the availability and timing of clinical and preclinical data announcements and clinical readouts, including additional interim data from the Phase 1 clinical trial for atopic dermatitis with soquelitinib; and the amount of net cash to fund operations into the first quarter of 2026. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on or about the date hereof, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of soquelitinib and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the cash on hand providing funding into the first quarter of 2026 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The Company’s results for the fourth quarter and year ended December 31, 2024 are not necessarily indicative of its operating results for any future periods.

INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
[email protected]

MEDIA CONTACT:

Sheryl Seapy
Real Chemistry
+1-949-903-4750
[email protected]

NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) — Rent the Runway, Inc. (“Rent the Runway”) (Nasdaq: RENT) announced today that it expects to release its fourth quarter and fiscal year 2024 financial results for the quarter and year ended January 31, 2025 on Tuesday, April 15, 2025, before market open. Rent the Runway will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time that same day to discuss its results and to provide a business update.

The financial results and live webcast, including presentation materials, will be accessible through the Investor Relations section of Rent the Runway’s website at https://investors.renttherunway.com/ under the “Events” section. To access the call through a conference line, dial 1-877-407-3982 (in the U.S.) or 1-201-493-6780 (international callers).

A replay of the conference call will be posted shortly after the call and will be available for at least fourteen days. To access the replay, dial 1-844-512-2921 (in the U.S.) or 1-412-317-6671 (international callers). The access code for the replay is 13752693.

About Rent the Runway

Founded in 2009, Rent the Runway is disrupting the trillion-dollar fashion industry and changing the way women get dressed through the Closet in the Cloud. RTR’s mission has remained the same since its founding: powering women to feel their best every day. Through RTR, customers can subscribe, rent items a-la-carte and shop resale from hundreds of designer brands. The Closet in the Cloud offers a wide assortment of millions of items for every occasion, from evening wear and accessories to ready-to-wear, workwear, denim, casual, maternity, outerwear, blouses, knitwear, loungewear, jewelry, handbags, activewear and ski wear. RTR has built a two-sided discovery engine, which connects deeply engaged customers and differentiated brand partners on a powerful platform built around its brand, data, logistics and technology. Under CEO and Co-Founder Jennifer Hyman’s leadership, RTR has been named to CNBC’s “Disruptor 50” five times in ten years, and has been placed on Fast Company’s Most Innovative Companies list four times, while Hyman herself has been named to the “TIME 100: Most Influential People in the World” and as one of People Magazine’s “Women Changing the World.”

Contacts

Press
[email protected]

Investor Relations
[email protected]

Update on IND-enabling data for MP0712, a Radio-DARPin targeting DLL3 and labeled with

²¹²

Pb, co-developed with Orano Med; entering FIH studies in 2025 for the treatment of small cell lung cancer

First preclinical data on second

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Pb-based Radio-DARPin co-developed with Orano Med, targeting the membrane-proximal region of mesothelin (MSLN) in solid tumors

Additional preclinical proof-of-concept data on CD3 Switch-DARPin T cell engager with CD2 co-stimulation in solid tumors

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., March 25, 2025 (GLOBE NEWSWIRE) — Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics (“Molecular Partners” or the “Company”), today announced it will hold three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30 in Chicago, IL.

Details of the presentations:

MP0712, the first anti-DLL3

²¹²

Pb Radio-DARPin (RDT) candidate for targeted radiotherapy of small cell lung cancer (SCLC)

Session Category: Experimental and Molecular Therapeutics
Session Title: Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies
Session Timing: Sunday April 27 at 2:00pm – 5:00pm CST
Location: Poster Section 16, Poster Board Number: 13
Published Abstract Number: 346

Development of

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Pb-based Radio-DARPin therapy (RDT) for the treatment of mesothelin (MSLN)-positive solid tumors

Session Category: Experimental and Molecular Therapeutics
Session Title: Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies
Session Timing: Sunday April 27 at 2:00 – 5:00pm CST
Location: Poster Section 16, Poster Board Number: 6
Published Abstract Number: 339

Next-generation multi-specific and conditionally activated CD3 Switch-DARPins with CD2 co-stimulation to tackle the current limitations of T cell engagers in solid tumors

Session Category: Experimental and Molecular Therapeutics
Session Title: Therapeutic Approaches to Attack the Tumor Microenvironment
Session Timing: Monday April 28 at 2:00pm – 5:00pm CST
Location: Poster Section 24, Poster Board Number: 3
Published Abstract Number: 3119

About Molecular Partners AG 

Molecular Partners AG is a clinical-stage biotech company pioneering the design and development of DARPin therapeutics for medical challenges other drug modalities cannot readily address. The Company has programs in various stages of pre-clinical and clinical development, with oncology as its main focus. Molecular Partners leverages the advantages of DARPins to provide unique solutions to patients through its proprietary programs as well as through partnerships with leading pharmaceutical companies. Molecular Partners was founded in 2004 and has offices in both Zurich, Switzerland and Concord, MA, USA. For more information, visit www.molecularpartners.com and find us on LinkedIn and Twitter/X  @MolecularPrtnrs

For further details, please contact:

Seth Lewis, SVP Investor Relations & Strategy
Concord, Massachusetts, U.S.
[email protected]
Tel: +1 781 420 2361

Laura Jeanbart, PhD, Head of Portfolio Management & Communications
Zurich-Schlieren, Switzerland
[email protected]
Tel: +41 44 575 19 35

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including without limitation: implied and express statements regarding the clinical development of Molecular Partners’ current or future product candidates; expectations regarding timing for reporting data from ongoing clinical trials or the initiation of future clinical trials; the potential therapeutic and clinical benefits of Molecular Partners’ product candidates and its RDT and Switch-DARPin platforms; the selection and development of future programs; Molecular Partners’ collaboration with Orano Med including the benefits and results that may be achieved through the collaboration; and Molecular Partners’ expected business and financial outlook, including anticipated expenses and cash utilization for 2025 and its expectation of its current cash runway and the expected use of proceeds from the October 2024 offering. These statements may be identified by words such as “aim”, “anticipate”, “expect”, “guidance”, “intend”, “outlook”, “plan”, “potential”, “will” and similar expressions, and are based on Molecular Partners’ current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from Molecular Partners’ expectations include its plans to develop and potentially commercialize its product candidates; Molecular Partners’ reliance on third party partners and collaborators over which it may not always have full control; Molecular Partners’ ongoing and planned clinical trials and preclinical studies for its product candidates, including the timing of such trials and studies; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; the timing of and Molecular Partners’ ability to obtain and maintain regulatory approvals for its product candidates; the extent of clinical trials potentially required for Molecular Partners’ product candidates; the clinical utility and ability to achieve market acceptance of Molecular Partners’ product candidates; the potential that Molecular Partners’ product candidates may exhibit serious adverse, undesirable or unacceptable side effects; the impact of any health pandemic, macroeconomic factors and other global events on Molecular Partners’ preclinical studies, clinical trials or operations, or the operations of third parties on which it relies; Molecular Partners’ plans and development of any new indications for its product candidates; Molecular Partners’ commercialization, marketing and manufacturing capabilities and strategy; Molecular Partners’ intellectual property position; Molecular Partners’ ability to identify and in-license additional product candidates; unanticipated factors in addition to the foregoing that may cause Molecular Partners’ actual results to differ from its financial and business projections and guidance; and other risks and uncertainties set forth in Molecular Partners’ Annual Report on Form 20-F for the year ended December 31, 2024 and other filings Molecular Partners makes with the SEC from time to time. These documents are available on the Investors page of Molecular Partners’ website at www.molecularpartners.com. In addition, this press release contains information relating to interim data as of the relevant data cutoff date, results of which may differ from topline results that may be obtained in the future. Any forward-looking statements speak only as of the date of this press release and are based on information available to Molecular Partners as of the date of this release, and Molecular Partners assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.