Data of InnoCare’s Robust Hemato-Oncology Pipelines Presented at the European Hematology Association (EHA) 2025 Congress

Data of InnoCare’s Robust Hemato-Oncology Pipelines Presented at the European Hematology Association (EHA) 2025 Congress




Data of InnoCare’s Robust Hemato-Oncology Pipelines Presented at the European Hematology Association (EHA) 2025 Congress

BEIJING–(BUSINESS WIRE)–Latest data of InnoCare’s (HKEX: 09969; SSE: 688428) robust oncology pipelines were presented at the ongoing European Hematology Association (EHA) 2025 Congress.

Poster Presentation:

1. First Presentation of Efficacy and Safety Data for First-Line Treatment of CLL/SLL with BCL2 Inhibitor Mesutoclax in Combination with BTK Inhibitor Orelabrutinib (Abstract No.: PS1567)

The study showed that mesutoclax (100 and 125 mg) in combination with orelabrutinib was safe and well tolerated in patients with treatment naïve (TN) CLL/SLL. Substantial efficacy was observed, with early high undetectable MRD (uMRD) rate.

42 patients with TN CLL/SLL were enrolled (mesutoclax 100 mg, n=21; 125 mg, n=21). The fixed-duration treatment of mesutoclax in combination with orelabrutinib is expected to deliver deeper remissions for TN CLL/SLL patients. In all patients, the overall response rate (ORR) was 97.6%.

At week 24 of the combination therapy, in the 125 mg dose cohort, the overall response rate (ORR) was 100%, the complete remission rate (CRR) was 23.8%, the CRR in target lesions was 57.1%, and the peripheral blood (PB) uMRD rate was 48%. In the 100 mg mesutoclax dose cohort, the ORR was 95.2%, the CRR was 19.0%, the CRR in target lesions was 42.9%, and the PB uMRD rate was 19%. With the extension of the duration of treatment, the therapeutic efficacy is expected to be further improved.

All patients are still on treatment. No disease progression or death occurred, and no adverse events leading to discontinuation of treatment were reported.

Due to its favorable efficacy and safety profile, a registrational Phase III clinical study of mesutoclax (125 mg once daily) in combination with orelabrutinib for the treatment of TN CLL/SLL patients has been initiated, with patient enrollment being accelerated.

2. Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab followed by Orelabrutinib Maintenance in Untreated Marginal Zone Lymphoma (OPTIMIZE): A Multicenter, Single-Arm, Phase II Study (Abstract No.: PF898)

The absence of a standard first-line treatment for marginal zone lymphoma (MZL) have inspired the exploration of novel regimens. In recent years, Bruton’s tyrosine kinase inhibitors (BTKis) have demonstrated durable responses with a favorable benefit-risk profile across all MZL subtypes in the relapsed/refractory setting. Orelabrutinib is a novel BTK inhibitor with higher selectivity and fewer off-target than other BTK inhibitors. Orelabrutinib combined with bendamustine-rituximab or obinutuzumab followed by orelabrutinib maintenance was effective and well-tolerated in untreated patients with MZL.

The majority of patients presented with MALT lymphoma and had Ann Arbor stage II-IV disease. At the end of induction treatment, the overall response rate (ORR) was 100.0% among all enrolled patients. At the data cutoff, the median progression-free survival (PFS) and overall survival (OS) remained immature. No BTK inhibitor-related adverse events (AEs), such as atrial fibrillation or bleeding, were observed.

3. The Rationality, Efficacy and Safety of Orelabrutinib plus Obinutuzumab (O2) in Systemic Treatment-naïve Marginal Zone Lymphoma: A Prospective Cohort Study (Abstract No.: PS1902)

The Orelabrutinib plus Obinutuzumab regimen had well rationality and demonstrated promising efficacy.

Across the entire study and during the period of induction therapy, the best objective response rate (ORR) was 100%. 3 patients who achieved partial response (PR) after the induction therapy subsequently achieved complete response (CR) in the maintenance period. The 18-month progression-free survival (PFS) and overall survival (OS) rates were both 100%.

4. Ultra-low Dose Radiotherapy Combined with Orelabrutinib Improves the Complete Response Rate of Treatment for Localized Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma (Abstract No.: PS1901)

The combination of ultra-low dose radiotherapy and orelabrutinib in the treatment of ocular adnexal extranodal marginal zone lymphoma (OA-EMZL) not only improves the effectiveness of treatment but also significantly reduces the toxic effects of radiotherapy, providing a new approach for the treatment of localized OA-EMZL.

Of all the 17 patients who completed treatment, 16 patients achieved complete response (CR) and one patient achieved a partial response. Additionally, the lesions in the patients still undergoing treatment have shrunk compared to before treatment.

5. Orelabrutinib plus Bendamustine-Rituximab (OBR) versus Bendamustine-Rituximab (BR) in Transplant-ineligible, Intermediate- to High-risk Mantle Cell Lymphoma (MCL) (Abstract No.: PS1969)

This open-label, randomized, multi-center study aims to compare the efficacy and safety of Orelabrutinib plus Bendamustine-Rituximab versus Bendamustine-Rituximab in transplant-ineligible, intermediate- to high-risk mantle cell lymphoma (MCL) patients. Early data suggest that Orelabrutinib plus Bendamustine-Rituximab could reduce disease progression events compared to Bendamustine-Rituximab in high-risk MCL. Updated outcomes on efficacy, safety, and biomarker analysis will be reported.

6. Pomalidomide, Rituximab, Orelabrutinib, and MiniCHOP-like (PRO-miniCHOP) in Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma: Updated Results from a Phase II Study (Abstract No.: PF950)

The results further support Pomalidomide, Rituximab, Orelabrutinib, and MiniCHOP-like (PRO-miniCHOP) as a potential treatment option for elderly patients with diffuse large B-cell lymphoma (DLBCL), demonstrating promising efficacy and acceptable safety, especially for those who responded to the Pomalidomide-Rituximab-Orelabrutinib (PRO) induction therapy.

A total of 32 patients were enrolled in this study, of whom 26 patients completed ≥3 cycles of the PRO-miniCHOP, resulting in a complete response rate (CRR) of 65.4% and overall response rate (ORR) of 100.0%. Among the 21 patients who completed the full 6-cycle therapy with PRO-miniCHOP, both the CRR and ORR were 95.2%. At a median follow-up of 15.6 months, the median progression-free survival (PFS) and overall survival (OS) had not yet been reached, with the 2-year PFS and OS rates being 94.7% and 100.0%, respectively.

7. Orelabrutinib Addition to R-CHOP-like Regimen Adapted to Response in Treatment-Naïve Non-GCB DLBCL: Update Results of Orient Study (Abstract No.: PS1943)

In non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL) patients who responded to orelabrutinib plus rituximab (OR) induction, orelabrutinib plus R-CHOP-like (OR-CHOP) exhibited favorable antitumor activity and manageable safety. Update results further support the orelabrutinib plus R-CHOP-like therapy as an option in this disease.

At end of 6-cycle orelabrutinib plus R-CHOP-like, response (all 100%) was independent of double-expressing lymphoma (DEL), extranodal involvement (EI), and Lymphgen subtypes. No off-target-related cardiac toxicities occurred.

8. Primary Efficacy and Safety of First-line R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) followed by Autologous Hematopoietic Stem Cell Transplantation in PCNSL (Abstract No.: PF966)

The Rituximab, Methotrexate, Thiotepa, and Orelabrutinib (R-MTO) induction treatment has demonstrated notable efficacy in achieving higher response rate among patients with newly diagnosed primary central nervous system lymphoma (PCNSL), with a manageable safety profile.

At the data cutoff, all patients had completed four cycles of induction therapy, and the complete response (CR) rate and overall response rate (ORR) were 93.34% and 96.67%, respectively. The 12-month progression-free survival (PFS) and overall survival (OS) rates were 82.26% and 85.33%, respectively.

9. Orelabrutinib, Rituximab Combined with High-Dose Methotrexate as Induction Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: PS1917)

This study demonstrated the promising efficacy of the Orelabrutinib, Rituximab Combined with High-Dose Methotrexate induction regimen in newly diagnosed primary central nervous system lymphoma (PCNSL), with encouraging response rates and durable progression-free survival (PFS). The regimen also showed promising overall survival (OS) trends, highlighting its potential as an effective treatment. Treatment-related adverse events (TRAEs) were manageable, and no severe BTK inhibitor-related off-target toxicities (e.g., atrial fibrillation/flutter) were observed. These findings suggest that the Orelabrutinib, Rituximab Combined with High-Dose Methotrexate regimen is a well-tolerated and effective therapeutic option for PCNSL.

Except the above poster presentations, more than 10 studies were also selected as poster presentations or online publications at the meeting. For more detailed clinical data, please refer to EHA website.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

Contacts

Media
Chunhua Lu

86-10-66609879

chunhua.lu@innocarepharma.com

Investors
86-10-66609999

ir@innocarepharma.com

 

SINOVAC’s Board of Directors Issues a Letter to Shareholders Outlining Clear Pathway to Restore Fairness and Deliver Value to All Shareholders

SINOVAC’s Board of Directors Issues a Letter to Shareholders Outlining Clear Pathway to Restore Fairness and Deliver Value to All Shareholders




SINOVAC’s Board of Directors Issues a Letter to Shareholders Outlining Clear Pathway to Restore Fairness and Deliver Value to All Shareholders

Intends to file definitive proxy materials in the coming days

BEIJING–(BUSINESS WIRE)–Sinovac Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it intends to file its definitive proxy materials in the coming days with the Securities and Exchange Commission (SEC) for the Special Meeting of Shareholders to be held on Wednesday, July 9, 2025 at 8:00 a.m. China Standard Time (Tuesday, July 8, 2025 at 8:00 p.m. Atlantic Standard Time). Valid shareholders of record as of the close of business on May 19, 2025 are entitled to vote at the meeting.

SINOVAC’s Board of Directors (the “SINOVAC Board”) also issued a letter to shareholders. The full text of the letter follows:

Dear SINOVAC Shareholder,

We are at a critical juncture for SINOVAC and, as a valued shareholder in the Company, you face an important decision at the upcoming Special Meeting of Shareholders.

A dissenting investor group led by Advantech/Prime Success (“Prime Success”) and Vivo Capital (together known as the “Dissenting Investor Group”) has launched a hostile attempt to remove the SINOVAC Board. Prime Success and Vivo Capital are not legitimate shareholders of the Company. Their ownership is the result of an invalid private investment in public equity (“PIPE”), which is in the process of being unwound.

The PIPE transaction was authorized by an illegitimate former board, which lost its seats at the February 2018 Annual General Meeting and failed to accept the outcome despite a clear shareholder vote. The UK Privy Council, in an unappealable ruling in January 2025, deemed this board to be an “Imposter Board”. Yet, during the years when the Imposter Board refused to vacate office, they distributed nearly US$2 billion in dividends to themselves, while distributing nothing to the valid shareholders of SINOVAC (including 1Globe Capital and OrbiMed). Additionally, the Dissenting Investor Group and Imposter Board collaborated to buy out SINOVAC at just US$7.00 per share, below market price, which was rejected by 1Globe Capital, the largest minority shareholder.

Since the Dissenting Investor Group knows they are not legitimate shareholders, they have requested the Special Shareholder Meeting through SAIF Partners to replace the SINOVAC Board with their own slate of nominees (the “Dissident Slate”).

We urge you not to be distracted by the Dissenting Investor Group’s hostile actions and false claims, nor to believe their sudden support of the dividend we declared, their empty promises to distribute more cash to you in the future, or the false allegations against the SINOVAC Board in their recent letter dated June 10, 2025. As we detailed in our April 29 letter, the Dissenting Investor Group’s self-serving actions blatantly interfere with the fair governance of our Company and pose a direct threat to the value of your investment and the future of SINOVAC.

The Dissenting Investor Group’s goal is clear: to protect the ill-gotten gains they stripped from SINOVAC subsidiaries over the past seven years and reinstate a complacent and complicit board that will allow them to continue such behavior and profit alongside.

The past actions of the Imposter Board – specifically, the invalid poison pill adopted in 2018 – directly caused the NASDAQ trading halt and the subsequent resignation of the Company’s former independent auditor. The Dissenting Investor Group and the Imposter Board have prioritized their own financial interests over those of all SINOVAC shareholders, while simultaneously undermining shareholder value and corporate governance and creating challenges that the SINOVAC Board is now working expeditiously to resolve.

At the Special Meeting of Shareholders, you will have a chance to send a clear message to the Dissenting Investor Group: SINOVAC will no longer be held captive to their self-dealing. We are moving forward, not backward. The rightful SINOVAC Board – reconstituted in February 2025 and led by respected and recognized industry leaders following seven years of legal efforts begun in 2018 by 1Globe Capital, SINOVAC’s single largest shareholder – is steadfast in its commitment to act in the best interests of ALL investors.

Importantly, the SINOVAC Board is fully aligned with the interests of common shareholders. 1Globe Capital and OrbiMed will vote their collective stake in SINOVAC AGAINST the Dissenting Investor Group’s misguided proposals.

Dr. Chiang Li, Chairman of the SINOVAC Board, despite being nominated to the Dissident Slate, unequivocally stands with the SINOVAC Board and firmly opposes the Dissenting Investor Group’s proposals at the Special Meeting of Shareholders. As the founder and Chairman of 1Globe Capital, Dr. Li’s track record over the past eight years speaks volumes about his unwavering commitment to governance, fairness, and shareholder value – including defending against multiple attempts by the Dissenting Investor Group at undervalued privatizations (US$7.00/share) and other transactions dilutive to SINOVAC shareholders, as well as personally financing the litigation that resulted in the non-appealable Privy Council ruling.

SINOVAC’s Board is focused on making shareholders whole, following years of self-serving practices by the Imposter Board, by:

  • Paying valid, rightful shareholders the previously declared US$55.00 dividend that the SINOVAC Board initiated immediately after being installed as a corrective step in returning an appropriate share of distributions to the Company’s common shareholders.
  • Creating the opportunity for future additional dividends to be paid from our operating subsidiaries to catch up ALL SINOVAC common shareholders with the Dissenting Investor Group.
  • Ensuring fair and equitable treatment of SINOVAC shareholders going forward, making distributions at the SINOVAC parent level and not just via operating subsidiaries directed by the Dissenting Investor Group.
  • Accelerating the resumption of trading on NASDAQ and potentially other exchanges to maximize shareholders’ investment return.
  • Protecting the best interests of and maximizing value for ALL valid shareholders.

In contrast, the Dissident Slate, which includes several members of the Imposter Board, will continue the Dissenting Investor Group’s track record of self-serving actions by:

  • Protecting their own ill-gotten gains made from the unauthorized PIPE investment and illegitimate convertible debt with our subsidiary, which diluted the ownership of and stole multi-billions of dollars from rightful SINOVAC shareholders and violated governance standards.

  • Stripping value from SINOVAC shareholders while attempting to delay and interfere with your special dividend through multiple lawsuits and intimidation tactics.

  • Pressuring SINOVAC to misappropriate the Company’s cash for investment into venture capital funds affiliated with the Dissenting Investor Group, prioritizing their own financial interests over the Company’s operational needs and the best interests of shareholders.

  • Propagating false claims to undermine the SINOVAC Board’s efforts to make shareholders whole through dividends, maintain the Company’s NASDAQ listing and resume trading.

  • Preventing the rightful SINOVAC Board from carrying out its fiduciary duties to you by refusing to accept the final and non-appealable Privy Council judgment and dragging the Company into a barrage of unnecessary litigation.

  • Calling a Special Shareholder Meeting, which is just one prong in a multifaceted strategy aimed at continuing to operate SINOVAC solely for the benefit of a few favored shareholders at the expense of all valid shareholders.

Actions Speak Louder Than Words: The SINOVAC Board Has Already Announced a Special Cash Dividend to Shareholders and a Commitment to Further Dividends

The SINOVAC Board has taken decisive steps to make shareholders whole by restoring fairness, integrity, and value to SINOVAC’s rightful shareholders after years of unfair practices under the Dissenting Investor Group-controlled Imposter Board. These steps include:

  • US$55.00 Per Share Special Dividend: In April 2025, after years of no allocation of the distributions enjoyed by the Dissenting Investor Group being made to SINOVAC common shareholders, the SINOVAC Board announced a special cash dividend of US$55.00 per common share, an initial corrective step to return value to you. We are working diligently to ensure this payout is completed on or about July 9, 2025, despite the Dissenting Investor Group’s lawfare, interference, threats and delay tactics, including via the Special Meeting of Shareholders.

  • New Dividend Commitment: The SINOVAC Board intends to pay out a pro rata portion of dividends to all SINOVAC shareholders to make you whole with dividends already taken out of the Company at the subsidiary level by the Dissenting Investor Group-controlled subsidiary shareholders, most of whom are affiliated with the Imposter Board. Details, including amount per share, will be announced in the near future.

  • Additional US$11.00 Per Share Dividend Redistribution: Upon cancellation of the unauthorized and fraudulent PIPE shares that were issued to Prime Success and Vivo Capital in 2018, the SINOVAC Board intends to redistribute the PIPE share portion of the US$55.00 per share dividend to all valid SINOVAC shareholders. The Dissenting Investor Group has already taken over US$800 million in dividends between 2021 and 2024 – all at the expense of valid SINOVAC shareholders who received nothing.

The SINOVAC Board is Committed to Creating Sustainable Value

In addition to distributing significant dividends to all SINOVAC shareholders, the SINOVAC Board is focused on:

  • Resolving NASDAQ Compliance and Auditor Issues: The SINOVAC Board is actively addressing past governance failures and working to restore NASDAQ compliance and hire an independent auditor as part of its efforts to resume trading of SINOVAC shares.

  • Executing a Global Growth Strategy: We are formulating long-term growth strategies to expand SINOVAC’s business in China and globally, leveraging our position as a leading provider of vaccine products.

  • Exploring a Dual Listing: Considering the geopolitical environment for U.S.-listed Chinese companies, the SINOVAC Board is also looking into the feasibility of an additional listing in Hong Kong.

A Destructive Future Awaits Under the Dissident Slate

We urge you – do not trust recent comments by Prime Success and Vivo Capital regarding their sudden embrace of dividends. How convenient is it that after years in which they lined their own pockets while you received nothing, they now are in support of dividends for all? These misleading comments are clearly an effort to further swindle shareholders and loot SINOVAC. And don’t just take our word for it – refer to the Company’s 2023 20-F, issued under the Imposter Board in April 2024, right after they granted the Dissenting Investor Group over US$800 million in dividends from SINOVAC’s operating subsidiary:

“We have never declared or paid any dividends, nor do we have any present plan to pay any cash dividends on Sinovac Antigua’s shares in the foreseeable future. We currently intend to retain most, if not all, of our available funds and any future earnings to operate and expand our business.” (emphasis added)

Here’s what you can expect if the Dissident Slate is elected at the upcoming Special Meeting of Shareholders:

  • Significant Risk that the US$55.00 Per Share Dividend Will Be Cancelled or Delayed Indefinitely: While they may be publicly supporting the US$55.00 dividend that we initiated, the reality is the Dissenting Investor Group has been attempting to block dividend payment through lawsuits and intimidation tactics. This includes intimidating our dividend payments agent to not facilitate your rightful dividend distribution. Several lawsuits have also been filed against SINOVAC Board members and their affiliates following the special dividend declaration.

  • No US$11.00 Per Share Dividend Redistribution: If the Dissident Slate gains control, the PIPE shares will not be cancelled and the additional US$11.00 per share redistribution will not be made to SINOVAC’s rightful shareholders and all future dividends will be diluted.

  • Privatization Risks at Below Market Value: The Imposter Board has a well-documented history of attempting to privatize SINOVAC at undervalued prices, which short-changes you once again. In 2017, it sought to privatize the Company at prices below market value, employing tactics such as unlawful poison pills to block competing bids and entrench its control. If the Dissident Slate gains power, there is a serious risk of a renewed privatization effort that could once again undervalue your shares and force a sale at a price far below SINOVAC’s true value.

  • Continued Self-Serving Actions: Under the Dissenting Investor Group’s control, the Imposter Board approved numerous unauthorized transactions that have diluted and consistently undermined the interests of SINOVAC’s rightful shareholders. This includes investing US$15 million in convertible debt for a 15% stake in our subsidiary, Sinovac Life Sciences Co. Ltd. (“SLS”) – the operating entity primarily responsible for the CoronaVac vaccine – immediately prior to the vaccine’s emergency use authorization in China. The Company did not need this US$15 million convertible debt. Six months later another investor paid US$515 million (34 times more) for an equivalent 15% stake in SLS – valuing SLS at over US$3.4 billion.

  • Ongoing Conflicts of Interest: Additionally, the Imposter Board committed to invest RMB1 billion (~US$139 million) of SINOVAC cash into a fund managed by Vivo Capital, where Shan Fu is a Managing Partner – creating a clear conflict of interest. SINOVAC has already invested approximately US$100 million into Vivo Capital funds. If elected, you should expect the Dissident Slate to continue this favored treatment of the Dissenting Investor Group at the expense of all valid shareholders.

  • Continued Mismanagement and Governance Failures: The Imposter Board’s actions, including the invalid poison pill, directly caused the NASDAQ trading halt in February 2019, trapping your investment during a time of immense growth and opportunity for SINOVAC. The Imposter Board’s financial mismanagement also led to a material weakness in SINOVAC’s internal controls, as disclosed by the Company’s former independent auditor, Grant Thornton Zhitong Certified Public Accountants LLP (“Grant Thornton”), and Grant Thornton’s subsequent resignation in 2025, which is expected to further delay resumption of NASDAQ trading.

  • Continued Erroneous Claims and Misinformation: As part of its coordinated and multifaceted effort to regain control, the Dissenting Investor Group has attempted to rewrite history and made blatantly false claims about the resignation of Grant Thornton in an attempt to mislead shareholders. In reality, Grant Thornton clearly stated its resignation was not the result of any disagreement with the current SINOVAC Board; the auditor resigned because, following the Privy Council’s ruling that the former Board were “Imposters”, Grant Thornton could not rely on representations about the Company’s financials in 2021, 2022, and 2023.

We cannot allow this pattern to continue.

Your Vote Will Be Important

This vote will be about the future of SINOVAC, your receipt of your make whole dividend payments in the near-term, and the long-term value of your investment. We look forward to sharing more details about the Dissenting Investor Group’s misguided proposals in our proxy materials, which we intend to file in the coming days.

Your vote will be critical to ensuring that SINOVAC remains on the path to stability, growth, and value creation for all shareholders.

Moving Forward Together

The SINOVAC Board is committed to restoring trust, fairness, and value for all shareholders. We are taking the necessary steps to correct the injustices of the past, investigate conflicts of interest, defend against the Dissenting Investor Group’s hostile actions, and position SINOVAC for a brighter tomorrow. We thank you for your continued confidence and support as we work to protect your investment and the future of SINOVAC.

Together, we can ensure that SINOVAC remains in the hands of leaders who are dedicated to acting in your best interests.

Sincerely,

The SINOVAC Board of Directors

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.

SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, etc.

The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under “Category 1 Preventative Biological Products” and commercialized in China in 2016. In 2022, SINOVAC’s Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.

SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.

SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.

Important Additional Information and Where to Find It

In connection with SINOVAC’s Special Meeting, SINOVAC will file with the U.S. Securities and Exchange Commission (“SEC”) and mail to shareholders of record entitled to vote at the Special Meeting a proxy statement and other documents, including a WHITE proxy card. SHAREHOLDERS ARE ENCOURAGED TO READ THE PROXY STATEMENT AND ALL OTHER RELEVANT DOCUMENTS WHEN FILED WITH THE SEC AND WHEN THEY BECOME AVAILABLE BECAUSE THOSE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION. When filed with the SEC, the proxy statement and WHITE proxy card will also be mailed to shareholders of record. Investors and other interested parties will be able to obtain the documents free of charge at the SEC’s website, www.sec.gov, or from SINOVAC at its website: https://www.sinovac.com/en-us/Investors/sec_filings. You may also obtain copies of SINOVAC’s proxy statement and other documents, free of charge, by contacting SINOVAC’s Investor Relations Department at ir@sinovac.com. Other information regarding potential participants in any such proxy solicitation will be filed by SINOVAC.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions, including the Company’s statements related to the Compliance Plan, and timing and actions taken to regain compliance with Nasdaq listing rules. Such statements are based upon the Company’s current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, including without limitation risks, uncertainties and factors related to the timing of engaging independent auditors and completion of the audits of required fiscal periods, completion and filing of the 2024 Annual Report, the Compliance Plan, and actions taken to regain compliance with the Nasdaq listing rules, all of which are difficult to predict and many of which are beyond the Company’s control, which may cause the Company’s actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

Contacts

Investor and Media Contacts
FGS Global

Sinovac@fgsglobal.com

Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet

Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet




Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet

  • POD1UM-303/InterAACT 2 is the first and largest global Phase 3 trial evaluating a PD-1 inhibitor in combination with chemotherapy for the treatment of patients with advanced SCAC not previously treated with systemic chemotherapy

  • The trial met its primary endpoint; treatment with retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel) resulted in clinically meaningful improvements in progression-free survival and overall survival

  • In May 2025, the U.S. Food and Drug Administration (FDA) approved Zynyz® (retifanlimab-dlwr) in combination with carboplatin and paclitaxel and as a single agent for the treatment of advanced SCAC; submissions to other global regulatory agencies are also under review

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that primary results from the Phase 3 POD1UM-303/InterAACT 2 trial of retifanlimab (Zynyz®), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) in adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal cancer (SCAC) who have not been previously treated with systemic chemotherapy, were published in The Lancet.1


“The publication of the POD1UM-303/InterAACT 2 trial in The Lancet is a testament to the strength of the data generated for retifanlimab in patients with inoperable locally recurrent or metastatic SCAC, a disease which until recently had seen limited innovation for decades,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “SCAC can be a devastating disease, and patients often have a poor prognosis. These data supported the U.S. Food and Drug Administration (FDA) approval of Zynyz® (retifanlimab-dlwr) in May 2025, providing U.S. patients the first and only first-line treatment for inoperable locally recurrent or metastatic SCAC.”

The POD1UM-303/InterAACT2 trial results, which were also featured at a Presidential Symposium on Practice-Changing Trials at the European Society for Medical Oncology (ESMO) in 2024, showed that the study met its primary endpoint by demonstrating a statistically significant improvement in progression-free survival (PFS) in patients with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy, as assessed by blinded independent central review (BICR) using RECIST v1.1.2 Adding retifanlimab to carboplatin and paclitaxel resulted in a clinically meaningful 37% reduction in the risk of progression or death (Hazard Ratio [HR]: 0.63; 95% Confidence Interval [CI] (0.47, 0.84); P=0.0006).2 Patients in the retifanlimab and chemotherapy combination group achieved a median PFS of 9.3 months compared to 7.4 months for patients in the placebo combination group.2

New data published today in The Lancet show that in patients treated with retifanlimab plus chemotherapy:1

  • A consistent benefit in PFS in favor of retifanlimab plus chemotherapy was observed for all pre-defined subgroups with sufficient patients for comparison.
  • A clinically meaningful 6-month difference in overall survival (OS) was observed at the interim analysis (29.2 months in the retifanlimab plus carboplatin and paclitaxel group vs 23.0 months in the placebo plus carboplatin and paclitaxel group). Interim OS results were not statistically significant, and patients continue to be followed for the final key secondary OS analysis.
  • The overall response rate (ORR) to treatment was improved by the addition of retifanlimab to the chemotherapy (55.8% in the retifanlimab plus carboplatin and paclitaxel group vs 44.2% in the placebo plus carboplatin and paclitaxel group) and the median duration of response was approximately doubled (14 months in the retifanlimab plus carboplatin and paclitaxel group vs 7.2 months in the placebo plus carboplatin and paclitaxel group) when compared to placebo.

As reported in The Lancet, no new safety signals were observed in POD1UM-303/InterAACT2, and safety was consistent with chemotherapy plus checkpoint inhibitor regimens. Serious and Grade 3 or worse adverse events were more frequent in the retifanlimab plus carboplatin and paclitaxel group compared with placebo plus carboplatin and paclitaxel group (47.4% vs 38.8% and 83.1% vs 75.0%, respectively). The most common Grade ≥3 adverse events were neutropenia (35.1% for retifanlimab plus carboplatin and paclitaxel vs 29.6% for placebo plus carboplatin and paclitaxel) and anemia (19.5% vs 20.4%). Despite the higher rate of serious, Grade 3 or worse, and fatal adverse events with retifanlimab plus carboplatin and paclitaxel than placebo plus carboplatin–paclitaxel, these toxicities were manageable with standard measures and carboplatin and paclitaxel delivery was not compromised.

The publication, entitled “Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial,” can be found online here.

“The incidence of SCAC is increasing by approximately 3% annually, driven mainly by endemic human papillomavirus (HPV infection). With no approved treatments available for advanced cases until recently, it is crucial to develop effective therapies for this orphan disease,” said Sheela Rao, M.D., Consultant Medical Oncologist, The Royal Marsden National Health Service Foundation Trust.

In May 2025, the FDA approved Zynyz® (retifanlimab-dlwr) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic SCAC. In addition, the FDA granted approval for Zynyz as a single agent for the treatment of adult patients with locally recurrent or with metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. Incyte has also submitted a Type II variation Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for retifanlimab in advanced SCAC and in March 2025 submitted and received acceptance of a Japanese New Drug Application (J-NDA) by the Pharmaceuticals and Medical Devices Agency (PMDA) for retifanlimab in advanced SCAC.

About Squamous Cell Carcinoma of the Anal Canal (SCAC)

SCAC is the most common type of anal cancer, making up 85% of cases.3 It is a rare disease for which the incidence is increasing approximately 3% per year.4 About 90% of cases are associated with human papillomavirus (HPV) infection—the number one risk factor for anal cancer.5 HIV is an important amplifier of anal cancer, as people with HIV are 25 to 35 times more likely to develop it.6,7 Anal cancer shares many of the same symptoms as non-cancerous conditions, such as hemorrhoids—including pain, itching, a lump or mass and changes in bowel movements—and as a result can go undetected leading to the majority of patients presenting with locally advanced disease.8,9 More information about SCAC is available by visiting www.analcancer.com.

About POD1UM

The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-303, POD1UM-202 and several other Phase 1, 2 and 3 studies for patients with solid tumors, including a registration-directed trial evaluating retifanlimab in combination with platinum-based chemotherapy for patients with non-small cell lung cancer.

About POD1UM-303/InterAACT 2

POD1UM-303/InterAACT 2 (NCT04472429) is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study evaluating retifanlimab or placebo in combination with platinum-based chemotherapy (carboplatin and paclitaxel) in adult patients with inoperable locally recurrent or metastatic SCAC who have not been previously treated with systemic chemotherapy.

During the blinded portion of the study, patients, including those with well-controlled HIV infection, were randomized 1:1 to receive retifanlimab 500 mg intravenously or placebo during each 28-day cycle for up to 6 months in combination with standard therapy of carboplatin and paclitaxel, followed by retifanlimab or placebo monotherapy for up to 1-year total treatment in the absence of disease progression or unacceptable toxicity. Crossover to retifanlimab monotherapy was allowed for patients assigned to placebo upon verification of progression by blinded independent central review (BICR).

The primary endpoint was progression-free survival (PFS) as determined by BICR using RECIST v1.1. The key secondary endpoint was overall survival (OS). Other secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR) by BICR, safety and pharmacokinetics.

For more information about the study, please visit https://clinicaltrials.gov/study/NCT04472429.

About Zynyz® (retifanlimab-dlwr)

Zynyz® (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

Zynyz is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Zynyz is marketed by Incyte in the United States. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

Important Safety Information

What is the most important information I should know about Zynyz?

Zynyz is a medicine that may treat certain types of cancers by working with your immune system. Zynyz can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your doctor right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, chest pain

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdomen) pain or tenderness

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, loss of appetite

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Zynyz. Call or see your doctor right away for any new or worsening signs or symptoms, which may include:

  • chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
  • confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • persistent or severe muscle pain or weakness, muscle cramps
  • low red blood cells, bruising

Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain.

Rejection of a transplanted organ or tissue. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease, in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Zynyz. Your doctor will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during your treatment. Your doctor may treat you with corticosteroid or hormone replacement medicines and may also need to delay or completely stop treatment if you have severe side effects.

Before you receive Zynyz, tell your doctor about all of your medical conditions, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have received an organ transplant or tissue transplant, including corneal transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have received radiation treatment to your chest area
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. Zynyz can harm your unborn baby

Females who are able to become pregnant:

  • Your doctor should do a pregnancy test before you start treatment.
  • You should use an effective method of birth control during your treatment and for 4 months after your last dose. Talk to your doctor about birth control methods that you can use during this time.
  • Tell your doctor right away if you become pregnant or think you may be pregnant during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if Zynyz passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Zynyz when given with the chemotherapy medicines carboplatin and paclitaxel in people with SCAC include tiredness, numbness, pain, tingling, or burning in your hands or feet; nausea; hair loss; diarrhea; muscle and bone pain; constipation; bleeding; rash; vomiting; decreased appetite; itching; stomach-area pain.

The most common side effects of Zynyz when used alone in people with SCAC include tiredness, muscle and bone pain, diarrhea, infection, rectal or genital-area pain, bleeding, urinary tract infection (UTI), rash, nausea, loss of appetite, constipation, stomach-area pain, shortness of breath, fever, vomiting, cough, itching, low levels of thyroid hormone, headache, decreased weight.

The most common side effects of Zynyz when used alone in people with MCC include tiredness, muscle and bone pain, itching, diarrhea, rash, fever, nausea.

These are not all the possible side effects of Zynyz. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.

General information about the safe and effective use of Zynyz

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about Zynyz, talk with your doctor. You can ask your doctor for information about Zynyz that is written for health professionals.

Please see the full Prescribing Information, including the Medication Guide, for Zynyz.

You may also report side effects to the FDA http://www.fda.gov/medwatch or to Incyte Corporation at 1-855-463-3463.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when Zynyz might provide a successful treatment option for patients with SCAC, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on Incyte‘s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by FDA or other regulatory authorities; Incyte‘s dependence on its relationships with its collaboration partners; the efficacy or safety of Incyte‘s products and the products of Incyte‘s collaboration partners; the acceptance of Incyte‘s products and the products of Incyte‘s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte‘s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended March 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.

 
1 Rao S, et al. Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial. The Lancet. 2025;405(10495):2144-52.
2 Lu S, et al. POD1UM-304: Phase 3 Study of Retifanlimab Plus Platinum-Based Chemotherapy as First-Line Therapy for Nonsquamous or Squamous Metastatic Non–Small Cell Lung Cancer. European Society of Medical Oncology (ESMO) Asia 2024.
3 Symer MM, Yeo HL. F1000Research. 2018;7:F1000 Faculty Rev-1572.
4 National Cancer Institute. Anal Cancer Incidence and Deaths Are Rising in the United States. https://www.cancer.gov/news-events/cancer-currents-blog/2019/anal-cancer-incidence-mortality-rise. Accessed April 16, 2025.
5 U.S. Centers for Disease Control and Prevention. Cancers Linked With HPV Each Year. https://www.cdc.gov/cancer/hpv/cases.html. Accessed April 16, 2025.
6 Wang C-CJ, et al. Surg Oncol Clin N Am. 2017;26:17-31.
7 NCCN Clinical Practice Guidelines in Oncology: Cancer in People with HIV. Version 1.2021. 2021.
8 Anal Cancer Foundation. Anal Cancer: Signs, Symptoms, Causes & Treatment. https://www.analcancerfoundation.org/what-is-anal-cancer/. Accessed April 16, 2025.
9 Rao S, et al. Ann Oncol. 2020;31(4):S1170-S1171.

 

Contacts

Media
media@incyte.com

Investors
ir@incyte.com

Quince Therapeutics Announces Pricing of Up to $22 Million Private Placement of Securities

Quince Therapeutics Announces Pricing of Up to $22 Million Private Placement of Securities




Quince Therapeutics Announces Pricing of Up to $22 Million Private Placement of Securities

Financing to provide $11.5 million in upfront proceeds with up to an additional $10.4 million of proceeds assuming exercise in full of the warrants

Financing priced at a premium to last close

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–$QNCX #biotech–Quince Therapeutics, Inc. (Nasdaq: QNCX) (“Quince” or the “Company”), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today announced that it has entered into a securities purchase agreement with certain institutional and accredited investors to purchase shares of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants (“Warrants”) that is expected to result in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying common warrants are exercised in full for cash, before deducting placement agent fees and other private placement expenses.


The private placement is being led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince’s senior management.

Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company’s pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with AT; NCT06193200/IEDAT-04-2022) clinical trial in Ataxia-Telangiectasia (A-T), research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince’s current cash, cash equivalents, and short-term investments are expected to fund the Company’s operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash.

At the closing, the Company will issue to the investors an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), along with accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company’s common stock). The accompanying Warrants have an exercise price of $1.20 per share and will become exercisable immediately. The Warrants will expire five years from the date of issuance. The private placement is expected to close during the week of June 16, 2025, subject to the satisfaction of customary closing conditions.

Citizens Capital Markets is acting as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-placement agents for the private placement.

The securities to be issued in connection with the private placement described above are being offered in a private placement and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdictions’ securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

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

About Quince Therapeutics

Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com.

Forward-looking Statements

Statements made in this news release that are not statements of historical or current facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this news release regarding the expected closing of the private placement; the receipt of additional gross proceeds if the accompanying common warrants are exercised in full; the achievement of positive clinical trial results and approval of the eDSP by the FDA; the company’s intended use of the proceeds from the private placement; the company’s expectation that the net proceeds from the closing of the private placement, combined with its current cash, cash equivalents and marketable securities, will fund its operating and capital expenditures into the second quarter of 2026, or the second half of 2026, assuming all warrants are exercised for cash; and the company’s strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to: cost, timing, progress and results of the pivotal Phase 3 NEAT clinical trial in A-T indication and potential future trials in other indications; the company’s ability to obtain FDA approval and successfully commercialize its product candidate; the satisfaction of customary closing conditions related to the proposed private placement and the impact of general economic, industry or political conditions in the United States or internationally, the current or evolving effects of macroeconomic conditions, on Quince’s business operations and activities. There can be no assurance that the company will be able to complete the proposed private placement on acceptable terms, or at all. Quince’s actual results, performance, or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including the risks discussed under the heading “Risk Factors” discussed under the caption “Item 1A. Risk Factors” in Part I of Quince’s most recent Annual Report on Form 10-K or any updates discussed under the caption “Item 1A. Risk Factors” in Part II of its Quarterly Reports on Form 10-Q and in the company’s other filings with the SEC. Quince undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as required by law.

Contacts

Media & Investor Contact:
Stacy Roughan

Quince Therapeutics, Inc.

Vice President, Corporate Communications & Investor Relations

ir@quincetx.com

BeOne Medicines to Host Investor R&D Day Webcast on June 26, 2025

BeOne Medicines to Host Investor R&D Day Webcast on June 26, 2025




BeOne Medicines to Host Investor R&D Day Webcast on June 26, 2025

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne–BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that it will host an Investor R&D Day in New York City and via webcast on June 26, 2025 at 8:30 am ET. John V. Oyler, Co-Founder, Chairman, and CEO of BeOne, along with the Company’s leadership team and distinguished key opinion leaders, will provide an update on BeOne’s extensive global innovation pipeline and platforms, including new assets, targets and clinical data, and will share insights on the Company’s vision, differentiated capabilities, and value creation drivers.


Live webcast of this event can be accessed from the investors section of the Company’s website at http://ir.beonemedicines.com/, https://hkexir. beonemedicines.com/, https://sseir. beonemedicines.com/. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the Company’s website.

About BeOne Medicines

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements

This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne’s plans, commitments, aspirations and goals related to BeOne’s medicines and drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors which are discussed in the section entitled “Risk Factors” in BeiGene’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”) as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this presentation is as of the date presented, and BeiGene undertakes no duty to update such information unless required by law.

Contacts

Investors:
Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media:
Kyle Blankenship

+1 667-351-5176

media@beonemed.com

Clinical and Pre-Clinical Data on the Novel Barriolide, EP395 (glasmacinal), Published in Three Articles in Pulmonary Pharmacology and Therapeutics

Clinical and Pre-Clinical Data on the Novel Barriolide, EP395 (glasmacinal), Published in Three Articles in Pulmonary Pharmacology and Therapeutics




Clinical and Pre-Clinical Data on the Novel Barriolide, EP395 (glasmacinal), Published in Three Articles in Pulmonary Pharmacology and Therapeutics

REYKJAVIK, Iceland–(BUSINESS WIRE)–EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’), a clinical-stage biopharmaceutical company developing a new class of oral anti-inflammatory drugs which enhance the host defence response to inhaled pathogens, has had three articles published in peer-reviewed journal, Pulmonary Pharmacology and Therapeutics.


These publications describe the potential for EpiEndo’s lead asset EP395, also known as ‘glasmacinal’, to be of therapeutic benefit in the treatment of COPD and support its continued clinical development. The article “Effect of EP395, a novel anti-inflammatory macrolide, in an inhaled lipopolysaccharide challenge model in healthy volunteers: a randomised controlled trial” reports that EP395 enhances the host defence response to inhaled LPS whilst reducing pro-inflammatory mediators. The paper was co-authored with investigators from Fraunhofer Institute for Toxicology and Experimental Medicine who conducted the study.

The second article, “Effects of EP395, a novel macrolide, on acute neutrophilic airway inflammation” describes preclinical data that demonstrate EP395 has comparable inhibitory effects on acute neutrophilic airway inflammation to azithromycin, which is used chronically off-label for its immunomodulatory properties to reduce COPD exacerbations.

Finally, “A novel macrolide, EP395, with reduced antibacterial activity and an enhancing effect on respiratory epithelial barrierreports that EP395 has negligible antibiotic activity and enhances the barrier function of the respiratory epithelium.

Maria Bech, CEO of EpiEndo Pharmaceticals commented:

“It is great to see the publication of this clinical and pre-clinical research in a peer-reviewed journal, highlighting the efficacy we are seeing with glasmacinal in neutrophilic inflammation.

“The anti-inflammatory effects of glasmacinal are comparable to those seen with azithromycin preclinically, but without anti-microbial activity. The clinical LPS study shows that EP395 enhances the host defence response to inhaled challenge, supporting our hypothesis that glasmacinal could be effective in reducing exacerbations in COPD but without developing anti-microbial resistance.

“We continue to develop glasmacinal as a potential new oral treatment option for COPD patients, aiming to bring additional therapeutic options to patients with chronic respiratory diseases.”

Professor Clive Page, Emeritus Professor of Pharmacology, King’s College London and Chairman of EpiEndo Pharmaceutical’s Scientific Advisory Board added:

“These exciting new data demonstrate glasmacinal’s effect on neutrophilic inflammation both in a clinical study and in established non-clinical models of airways disease. These novel findings, coupled with data presented at ERS in 2024 on EP395’s anti-inflammatory effect on eosinophilic inflammation (caused by allergens), demonstrate the broad anti-inflammatory activity of this drug that has the potential to provide a novel, groundbreaking approach to treat patients with COPD, irrespective of their type of inflammation.”

About EpiEndo Pharmaceuticals (www.epiendo.com)

EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to chronic respiratory diseases that focuses on the role of epithelial function in various inflammatory disorders.

EpiEndo’s new class of orally available macrolides, with reduced antimicrobial resistance (AMR) potential, known as ‘Barriolides™’, show promise as first-in-class therapeutics for chronic respiratory diseases as well as other inflammatory indications. EpiEndo’s lead asset, glasmacinal, was the first Barriolide™ to enter clinical trials, for chronic obstructive pulmonary disease (COPD).

Glasmacinal aims to be a first on-market oral treatment which is anti-inflammatory and enhances the host defense response to inhaled pathogens such as viruses, bacteria & pollution.​ Therefore, glasmacinal has the potential to become an impactful treatment in reducing exacerbations in patients with COPD.

According to the WHO, COPD is the third leading cause of death globally, and the global economic burden of COPD is projected to cost $4.8 trillion by 2030.

Contacts

EpiEndo Pharmaceuticals:
Maria Bech, CEO

+354 454 0090

Vigo Consulting (media relations):

Rozi Morris

+44 20 7390 0230

epiendo@vigoconsulting.com

3D Investment Partners: Leading Proxy Advisory Firm Glass Lewis Recommends Toho Holdings Shareholders Vote “AGAINST” the Reappointment of CEO Hiromi Edahiro at the Company’s June 2025 AGM

3D Investment Partners: Leading Proxy Advisory Firm Glass Lewis Recommends Toho Holdings Shareholders Vote “AGAINST” the Reappointment of CEO Hiromi Edahiro at the Company’s June 2025 AGM




3D Investment Partners: Leading Proxy Advisory Firm Glass Lewis Recommends Toho Holdings Shareholders Vote “AGAINST” the Reappointment of CEO Hiromi Edahiro at the Company’s June 2025 AGM

Glass Lewis Highlights “Relevant and Substantiated Concerns Regarding Toho Holdings’ Governance Practices,” Especially the Company’s Response to the Nihon University Incident

Believes Shareholders Should Expect “Stronger Accountability and Leadership at the Highest Levels” and Advises Shareholders to Vote Against the Reappointment of CEO Hiromi Edahiro in order to “Express Their Concerns and Dissatisfaction”

TOKYO–(BUSINESS WIRE)–3D Investment Partners Pte. Ltd., the investment manager of 3D Opportunity Master Fund (“3D” or “we”), today announced that Glass, Lewis & Co. (“Glass Lewis”), a leading independent provider of proxy research and voting recommendations for the institutional investor community, has recommended that shareholders of Toho Holdings Co., Ltd. (“Toho HD” or the “Company”) (TOKYO: 8129) vote “AGAINST” the reappointment of Representative Director, President, CEO and CFO Hiromi Edahiro (“Mr. Edahiro”) at the Company’s 77th Annual General Meeting of Shareholders (the “AGM”), scheduled to be held on June 27, 2025.


In its report, Glass Lewis recognized that 3D “raises relevant and substantiated concerns regarding Toho Holdings’ governance practices” and concluded that shareholders should vote against the reappointment of Mr. Edahiro.

In reaching its conclusion, Glass Lewis highlighted Toho HD’s fraudulent scheme related to Nihon University Hospital (the “Nihon University Incident”) and found that the incident – which was “characterized by limited disclosure and unclear accountability” – warranted “further scrutiny.”

Furthermore, Glass Lewis criticized Toho HD’s response to the Nihon University Incident particularly; they analyze that this incident suggested “gaps in the Company’s risk awareness and disclosure governance framework.” Glass Lewis noted that:

  • “[T]he Company’s involvement in transactions perceived as questionable might have merited a more proactive and transparent response. From the standpoint of risk oversight and shareholder communication, an internal investigation followed by a timely explanation would likely have been more appropriate.”
  • “[T]he Company’s first formal disclosure [of the Nihon University Incident] was issued only in response to 3D’s public statements ahead of this shareholder meeting. In our view, this reactive approach appears misaligned with generally accepted expectations for corporate transparency. The rationale cited—that disclosure was delayed to protect the Company’s reputation—may in fact have had the opposite effect, potentially exacerbating reputational risks.”

3D completely agrees with Glass Lewis that shareholders should expect “stronger accountability and leadership at the highest levels.” 3D strongly believes that addressing Toho HD’s serious governance and compliance failures is essential to enhance the Company’s corporate value sustainably, and that substantive change must start at the top of the organization.

3D therefore encourages Toho HD shareholders to vote AGAINST Mr. Edahiro at the Company’s upcoming AGM.

Note: The passages in quotation marks (“”) are direct quotes excerpted by 3D from Glass Lewis’ report. The portions in brackets ([ ]) have been added by 3D for additional clarity/context. Permission to use these quotes from Glass Lewis was neither explicitly sought nor obtained.

About 3D Investment Partners Pte. Ltd.

3D Investment Partners Pte. Ltd. is an independent Singapore-based Japan focused value investing fund manager founded in 2015. 3D Investment Partners Pte. Ltd. focuses on partnering with management[s] who share its investment philosophy of medium- to long-term value creation through compound capital growth and a common objective of achieving long-term returns.

Disclaimer

This press release, including annexes is provided for informational purposes only and does not constitute an offer to purchase or sell any security or investment product, nor does it constitute professional or investment advice. This press release should not be relied on by any person for any purpose and is not, and should not be construed as investment, financial, legal, tax or other advice.

3D Investment Partners Pte. Ltd. and its affiliates and related persons (“3DIP”) of either believe that the current market price of Toho HD does not reflect its intrinsic value. 3DIP acquired beneficial and/or economic interests based on its own idea that Toho HD securities have been undervalued and provide an attractive investment opportunity and may in the future beneficially own, and/or have an economic interest in, Toho HD securities. 3DIP intends to review its investments in Toho HD on a continuing basis and, depending upon various factors including, without limitation, Toho HD’s financial position and strategic direction, the outcome of any discussions with Toho HD, overall market conditions, other investment opportunities available to 3DIP, and the availability of Toho HD securities at prices that would make the purchase or sale of Toho HD securities desirable, 3DIP may, from time to time (in the open market or in private transactions), buy, sell, cover, hedge, or otherwise change the form or substance of any of its investments (including the investment in Toho HD securities) to any degree in any manner permitted by any applicable law, and expressly disclaims any obligation to notify others of any such changes.

3DIP provides no representation or warranty, either expressed or implied, in relation to the accuracy, completeness, or reliability of the information contained herein (including content or quotes from news coverage or other third-party public sources (“Third-Party Materials”)), nor is it intended to be a complete statement or summary of the securities, markets, or developments referred to herein. 3DIP expressly disclaims any responsibility or liability for any loss whatsoever arising from any use of, or reliance on, this press release or its contents as a whole or in part by any person, or otherwise whatsoever arising in connection with this press release. 3DIP hereby expressly disclaims any obligation to update or provide additional information regarding the contents of this press release or to correct any inaccuracies in the information contained in this press release.

3DIP disclaims any intention or agreement to be treated as a joint holder (kyodo hoyu sha) under the Financial Instruments and Exchange Act of Japan, a closely related party (missetsu kankei sha) under the Foreign Exchange and Foreign Trade Act with other shareholders, or receiving any power or permission to represent other shareholders in relation to the exercise of their voting rights, and has no intention to solicit, encourage, induce or require any person to cause other shareholders to represent such voting rights.

3DIP does not have the intention to make a proposal, directly or through other shareholders of Toho HD, to transfer or abolish the business or assets of Toho HD and/or Toho HD group companies at the general shareholders meeting of Toho HD. 3DIP does not have the intention or purpose to engage in any conduct which constricts the continuing and stable implementation of business of Toho HD and/or Toho HD group companies.

This press release may include Third-Party Materials. Permission to quote from Third-Party Materials in this press release may neither have been sought nor obtained. The content of the Third-Party Materials has not been independently verified by 3DIP and does not necessarily represent the views of 3DIP. The authors and/or publishers of the Third-Party Materials are independent of, and may have different views to 3DIP. Quoting Third-Party Materials in this press release does not imply that 3DIP endorses or concurs with any part of the content of the Third-Party Materials or that any of the authors or publishers of the Third-Party Materials endorses or concurs with any views which have been expressed by 3DIP on the relevant subject matter. The Third-Party Materials may not be representative of all relevant news coverage or views expressed by other third parties on the stated issues.

In respect of information that has been prepared by 3DIP (and not otherwise attributed to any other party) and which appears in the English language version of this press release, in the event of any inconsistency between the English language version and the Japanese language version of this press release, the meaning of the Japanese language version shall prevail unless otherwise expressly indicated.

Contacts

KRIK (PR Agent)

Koshida: +81-70-8793-3990

Sugiyama: +81-70-8793-3989

Bayer and Broad Institute Extend Research Collaboration to Develop New Cardiovascular Therapies

Bayer and Broad Institute Extend Research Collaboration to Develop New Cardiovascular Therapies




Bayer and Broad Institute Extend Research Collaboration to Develop New Cardiovascular Therapies

  • Focus on joint discovery of novel therapeutic approaches based on findings in human genomics research related to cardiovascular diseases
  • Current efforts focused on treatment options for specific forms of cardiovascular disease such as dilated cardiomyopathy
  • Phase I clinical study in healthy volunteers for development of new treatment for patients with atrial fibrillation recently initiated
  • Extended collaboration to further strengthen Bayer’s precision cardiology pipeline

BERLIN & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bayer and the Broad Institute today announced that they have extended their research collaboration of 10 years by an additional five years, to further advance findings in human genomics research in cardiovascular diseases. The expanded agreement will focus on joint precision cardiology target identification, leveraging the established human cardiomyocyte platform to rapidly validate observations, and discovery of novel therapeutic approaches.

Current efforts are directed to develop potential treatment options for patients with specific forms of cardiovascular disease such as dilated cardiomyopathy (DCM), amongst others. DCM is a type of heart disease characterized by the enlargement of the heart’s chambers, which leads to a decreased ability to pump blood effectively. This condition can result in heart failure and other complications if left untreated.1

Established in 2013, this longstanding collaboration combines the Broad Institute’s extensive expertise in genomics and biology with Bayer’s in-depth experience in small, chemically manufactured molecules and biologics drug discovery to advance drug discovery research for novel cardiovascular therapeutics. This strategic research alliance already has resulted in a number of joint publications and conference presentations, and it has paved the way for Bayer’s announcement in May 2025 regarding the initiation of a Phase I study with its investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor which has a potential to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib).

“We are constantly evaluating novel approaches to treat cardiovascular diseases that affect millions of people worldwide. Our shared commitment is to explore novel therapeutic targets and modalities in various cardiovascular and renal diseases to help deliver new treatment options to patients in need,” said Andrea Haegebarth, Ph.D., Global Head of Research and Early Development for Cardiovascular, Renal, and Immunology at Bayer’s Pharmaceuticals Division. “The first joint therapeutic project entered the clinic last month and we are excited to collaborate further with the esteemed scientists at the Broad Institute to identify and develop disease-modifying therapeutics treating underlying causes of cardiovascular diseases.”

“I am delighted to see Broad and Bayer continue this fruitful collaboration in cardiovascular research,” said Todd Golub, director and founding core member of the Broad Institute. “By working together, Broad and Bayer are able to make advances that neither organization could make on its own.”

Academic collaborations are integral to Bayer’s research and development strategy, aimed at delivering innovative treatment solutions to patients, particularly in areas with significant unmet medical needs, such as cardiovascular health. Bayer’s strategic focus in cardiovascular research emphasizes precision drug development, facilitating the rapid identification of the most promising targets and commercially viable programs.

Bayer with its Bayer Research & Innovation Center (BRIC) is closely located to the Broad Institute in Kendall Square, Cambridge, MA. BRIC houses a center of precision oncology research as well as an experienced team of scientists focused on research and early development for developing precision cardiovascular, renal, and immunology therapeutics. BRIC is also home to Bayer Co.Lab Cambridge which is part of a pioneering global network of life science incubators focused on disruptive innovation and scientific breakthroughs.

Financial details have not been disclosed.

About Bayer’s Commitment in Cardiovascular Diseases

Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. The strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several innovative products as well as compounds in various stages of preclinical and clinical development.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer

 ________________________

1 Ferreira A, Ferreira V, Antunes MM, Lousinha A, Pereira-da-Silva T, Antunes D, Cunha PS, Oliveira M, Ferreira RC, Rosa SA. Dilated Cardiomyopathy: A Comprehensive Approach to Diagnosis and Risk Stratification. Biomedicines. 2023 Mar 9;11(3):834. doi: 10.3390/biomedicines11030834. PMID: 36979813; PMCID: PMC10044994.

aka (2025e-0114)

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Bayer Global Media Contact:

Derin Denham, phone +1 973 610 7324
Email: derin.denham@bayer.com

Bayer U.S. Media Contact:

Elaine Colon, phone +1 732 236 1587
Email: elaine.colon@bayer.com

 

Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

FOSTER CITY, Calif.–(BUSINESS WIRE)–Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that on June 10, 2025, the Compensation Committee of Mirum’s Board of Directors granted inducement awards consisting of non-qualified stock options to purchase 115,620 shares of common stock and 57,740 restricted stock units (“RSUs”) to 10 new employees under Mirum’s 2020 Inducement Plan. The Compensation Committee of Mirum’s Board of Directors approved the awards as an inducement material to the new employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).


Each stock option has an exercise price per share equal to $48.98 per share, Mirum’s closing trading price on June 10, 2025, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employees’ continued service relationship with Mirum through the applicable vesting dates. The RSUs will vest over three years, with 33% of the underlying shares vesting on each anniversary of the applicable vesting commencement date, subject to the new employees’ continued service relationship with Mirum through the applicable vesting dates. The awards are subject to the terms and conditions of Mirum’s 2020 Inducement Plan and the terms and conditions of an applicable award agreement covering the grant.

About Mirum Pharmaceuticals, Inc.

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Mirum has three approved medications: LIVMARLI® (maralixibat), CHOLBAM® (cholic acid) capsules, and CTEXLI™ (chenodiol) tablets.

LIVMARLI, an IBAT inhibitor, is approved for the treatment of two rare liver diseases affecting children and adults. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome in the U.S. (three months and older), in Europe (two months and older), and in other regions globally. It is also approved in the U.S. in cholestatic pruritus in PFIC patients 12 months of age and older; in Europe, it is approved for patients with PFIC three months of age and older. Mirum is also initiating the Phase 3 EXPAND study, a label expansion opportunity for LIVMARLI in additional settings of cholestatic pruritus. CHOLBAM is FDA-approved for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients who show signs or symptoms of liver disease. CTEXLI is FDA-approved for the treatment of cerebrotendinous xanthomatosis (CTX) in adults.

Mirum’s late-stage pipeline includes two investigational treatments for several rare diseases. Volixibat, an IBAT inhibitor, is being evaluated in two potentially registrational studies including the Phase 2 VISTAS study for primary sclerosing cholangitis (PSC) and Phase 2b VANTAGE study for primary biliary cholangitis (PBC). Volixibat has been granted Breakthrough Therapy Designation for the treatment of cholestatic pruritus in patients with PBC. Mirum is also planning for a Phase 2 study evaluating MRM-3379, a PDE4D inhibitor for the treatment of Fragile X syndrome, a rare genetic neurocognitive disorder.

To learn more about Mirum, visit mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and X.

Contacts

Investor Contact:
Andrew McKibben

ir@mirumpharma.com

Media Contact:
Erin Murphy

media@mirumpharma.com

Global Healthy Living Foundation Peer-Reviewed Research Shows Hidden Risks of the Inflation Reduction Act’s Drug Pricing Reform

Global Healthy Living Foundation Peer-Reviewed Research Shows Hidden Risks of the Inflation Reduction Act’s Drug Pricing Reform




Global Healthy Living Foundation Peer-Reviewed Research Shows Hidden Risks of the Inflation Reduction Act’s Drug Pricing Reform

Report reveals potential for higher patient costs, worse health outcomes despite lower “fair prices”


UPPER NYACK, N.Y.–(BUSINESS WIRE)–The Global Healthy Living Foundation (GHLF) has launched a research-backed public education campaign to raise awareness about the unintended consequences of drug pricing reforms under the Inflation Reduction Act (IRA). This initiative stems from a recent peer-reviewed paper co-authored by GHLF’s Chief Science Policy Officer, Dr. Robert Popovian, Pharm.D., MS, published in the Journal of Health Economics and Outcomes Research (JHEOR). It includes a podcast episode, an infographic, and an article aimed at informing patients, caregivers, and policymakers.

“The IRA’s “maximum fair price” (MFP) policy was designed to reduce out-of-pocket costs for Medicare patients. However, it may lead to the opposite: higher out-of-pocket costs and increased health risks for vulnerable patients,” report author Dr. Popovian says

“By suppressing the retail price, CMS is reducing the profit margins and revenue for pharmacy benefit managers (PBMs), which is good. Predictably, the PBMs will not stand pat—they can shift the drug to a higher formulary tier, where patients will pay more out-of-pocket to acquire the medicine so the PBM can protect its profit margin,” said Dr. Popovian in a recent episode of GHLF’s Healthcare Matters podcast.

The study specifically modeled outcomes for two widely used blood thinners, Eliquis and Xarelto. If PBMs reclassify these drugs to higher cost tiers to compensate for lost profit, patients could face an estimated $688 million more in out-of-pocket costs. This cost-shift could result in over 320,000 patients abandoning treatment, potentially leading to 145,000 major cardiovascular events and up to 97,000 deaths.

“This research underscores a serious gap in how drug pricing reforms are being implemented and monitored,” said Dr. Popovian. “Without proper oversight and transparency, policies that were meant to help patients could end up hurting them.”

The GHLF education campaign includes:

  • A peer-reviewed paper published in JHEOR: “Could the Inflation Reduction Act Maximum Fair Price Hurt Patients?”
  • A patient-friendly article: “Lower Prices, Higher Risk: How Drug Reform Could Backfire on Patients” published on GHLF’s website and supported by social media
  • A special podcast episode of Healthcare Matters, co-hosted by Dr. Popovian
  • A downloadable infographic explaining the findings at-a-glance

“This campaign is not about politics—it’s about patients,” said Seth Ginsberg, GHLF Co-Founder and President. “We want people to understand what’s at stake when reforms don’t account for the full complexity of our health care system.”

GHLF encourages policymakers, journalists, and patient advocates to explore these resources and consider how reforms like the IRA impact access to critical medications.

About GHLF

The Global Healthy Living Foundation is a U.S. based, 501(c)(3) nonprofit, international organization whose mission is to improve the quality of life for people with chronic illnesses by advocating for improved access to health care through education, patient-centered clinical research, support, advocacy, and economic and policy research. GHLF is also a staunch advocate for vaccines. The Global Healthy Living Foundation is the parent organization of CreakyJoints®, the international, digital community for millions of people living with arthritis and their supporters worldwide who seek education, support, activism, and patient-centered research in English, Spanish, and French. In addition to arthritis and autoimmune disorders, GHLF supports dermatology, gastroenterology, neurology, cardiology, oncology, infectious disease, rare disease, and pulmonary patients through a host of different programs and activities which draw more than 700,000 patients a month to GHLF websites and create more than 10 million impressions a month on seven social media platforms. In 2024, GHLF had more than 1 million views and listens with its patient-centered audio-visual content, found on YouTube and podcast platforms. GHLF never asks the public for donations, receiving funding instead through governments, non-governmental organizations, foundations, industry, family foundations, and GHLF Co-Founder Louis Tharp. Visit www.ghlf.org for more information.

Contacts

Louis Tharp

ltharp@ghlf.org
www.ghlf.org