Market Newsdesk

MUNCIE, Ind., Oct. 01, 2026 (GLOBE NEWSWIRE) — First Merchants Corporation (NASDAQ: FRME) today announced that CEO Mark Hardwick will retire at the end of the year after 29 years with the bank. The First Merchants Corporation Board of Directors announced that Mike Stewart, current First Merchants Bank President who has been with the bank for more than 18 years, will become President and CEO at the start of 2027.

“We wish Mark well and are grateful for his outstanding leadership through years of tremendous growth, including 18 acquisitions during his tenure,” said Jean Wojtowicz, Chair of the Board of Directors of First Merchants Corporation and First Merchants Bank. “We are extremely pleased to have a seasoned leader in Mike Stewart who has already proven ready to take First Merchants to the next level.”

“It’s been my great pleasure to serve as the CEO of this 133-year-old financial institution with nearly 300,000 clients, 126 locations in 3 states, and 2,200 employees who work every day to enhance the financial wellness of our communities and clients,” said Hardwick. “First Merchants is a company with a wonderful culture and endless opportunities. We have boldly stepped into those opportunities with a courageous expectant attitude.

“My faith is an important part of my life, and I want to dedicate more time to consultative faith-based leadership. My wife Cathy and I are excited about the next chapter in our life’s journey, and I am also incredibly proud of what we as a bank leadership team have accomplished together at First Merchants.”

Stewart is a familiar face to those inside and outside the Bank as an active leader in the community, currently serving on the Board of the Indianapolis Neighborhood Housing Partnership (INHP); Greater Indianapolis Progress Committee (GIPC), Indy Chamber, Indiana Chamber, Park Tudor Foundation and Second Presbyterian Foundation.

He also actively participates in Streets to Home Indy, Indiana Bankers Association, and American Heart Association. He previously served as Chairman of the Board of Bosma Industries and was a 20-year board member.

“We will continue our focus on organically growing in the communities we serve with renewed vigor,” said Stewart. “We have an excellent executive team, supported by locally based senior leaders across our footprint. Our strategy is to build on our Midwestern strength, growing through more and deeper relationships, smarter use of technology, and customer-centric products that expand our reach.

“My wife, Barb, and I have loved living in Indianapolis for 38 years and are excited for this next chapter of leading the bank to new levels of strength in Indy and in every market First Merchants is privileged to serve.”

About First Merchants Corporation  

With approximately $21 billion in assets, First Merchants Corporation (NASDAQ: FRME) is a registered bank holding company offering a full line of commercial and consumer banking services and wealth management services through First Merchants Bank and First Merchants Private Wealth Advisors in Indiana, Michigan, and Ohio. With more than 130 years of enhancing the financial wellness of the diverse communities it serves, First Merchants makes meaningful contributions through employee empowerment, philanthropy, charitable giving, financial wellness, and community home and business lending. The company has been honored for its attentive and knowledgeable service and culture by Forbes, Time Magazine, American Banker, and S&P Global Intelligence “Best Banks” awards. First Merchants attributes this recognition to a mission-driven team that is passionate about “helping you prosper” through attentiveness as its genuine and unique approach to customer service. To see how First Merchants is making a difference, go to https://www.firstmerchants.com/. 

Media Contact

Amy Hanna
Borshoff
317.695.6331
[email protected]

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/e0e6cdc7-46b0-4cde-9a81-e89962fb9658 

https://www.globenewswire.com/NewsRoom/AttachmentNg/4a12b290-5b9e-4c30-a8db-44c03879e7f9 

ENGLEWOOD, Colo., Oct. 01, 2026 (GLOBE NEWSWIRE) — Gevo, Inc. (NASDAQ: GEVO) today announced sales of substantially all of the Section 45Z tax credits generated by its ethanol and renewable natural gas (RNG) facilities in 2026, totaling $70 million worth of credits. Gevo has received over $30 million in cash from these credit sales through September 30 and expects the remaining cash to be received over the next six months. The credits were generated through the production and sale of low-carbon transportation fuels and were sold by Gevo pursuant to the credit’s transferability provisions. 

On September 30, Gevo sold $50 million worth of credits to a non-financial, publicly traded company. Gevo previously sold $20 million worth of credits to Quill Financial, Inc., the parent company of Quill Bank, a Utah-based community bank providing commercial, agricultural, mortgage and consumer banking services.

“We have successfully sold our expected 2026 45Z tax credit position while broadening participation beyond financial institutions to also include strategic corporate buyers,” said Gevo Chief Executive Officer Paul Bloom. “By efficiently monetizing the value generated through our low-carbon fuel operations, we are increasing cash on the balance sheet, enhancing financial flexibility and creating additional value for shareholders.”

Gevo expects to produce an additional $7 to $10 million worth of Section 45Z tax credits in 2027 due to the anticipated completion of debottlenecking activities at Gevo North Dakota that is expected to increase production capacity and associated carbon capture by 10-15%. The debottlenecking remains on track to be completed by the end of 2026.

The 45Z tax credit sales help Gevo to reinvest in low-cost, domestic clean fuel production. These investments support domestic energy security, create jobs in rural America and increase demand for agricultural products grown by U.S. farmers through expanding production and creating long-term shareholder value. As a performance-based credit, 45Z incentivizes investments in efficiency and carbon intensity reduction that enhance the competitiveness of clean fuels and U.S. agriculture.   

About Gevo

Gevo is a next-generation diversified energy company committed to fueling America’s future with cost-effective, drop-in fuels that contribute to energy security, abate carbon, and strengthen rural communities to drive economic growth. Gevo’s innovative technology can be used to make a variety of renewable products, including sustainable aviation fuel (SAF), motor fuels, chemicals, and other materials that provide U.S.-made solutions. Gevo’s business model includes developing, financing, and operating production facilities that create jobs and revitalize communities. Gevo owns and operates an ethanol plant with an adjacent carbon capture and storage (CCS) facility and Class VI carbon-storage well. Gevo also owns and operates one of the largest dairy-based renewable natural gas (RNG) facilities in the United States, turning by-products into clean, reliable energy. Additionally, Gevo developed the world’s first production facility for specialty alcohol-to-jet (ATJ) fuels and chemicals operating since 2012. Gevo is currently developing the world’s first large-scale ATJ facility to be co-located at our North Dakota site. Gevo’s market-driven “pay-for-performance” approach regarding carbon and other sustainability attributes helps deliver value to our local economies. Through its Verity subsidiary, Gevo provides transparency, accountability, and efficiency in tracking, measuring, and verifying various attributes throughout the supply chain. By strengthening rural economies, Gevo is working to secure a self-sufficient future and to make sure value is brought to the market.

For more information, please visit www.gevo.com. 

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to a variety of matters, including, without limitation, the financial aspects of the 45Z tax credit sales, future 45Z tax credit production and sales, any effects of the 45Z sales transactions on Gevo’s cash flows, gross margin and adjusted EBITDA and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Gevo and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Gevo undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Gevo believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Gevo in general, see the risk disclosures in the Annual Report on Form 10-K of Gevo for the year ended December 31, 2025, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the U.S. Securities and Exchange Commission by Gevo.

Media Contact

[email protected]

IR Contact

[email protected]

PLYMOUTH MEETING, Pa., Oct. 01, 2026 (GLOBE NEWSWIRE) — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will present a poster featuring information from its ongoing Phase 3 trials of HBS-301, including ONSTRIDE-1 in narcolepsy and ONSTRIDE-2 in idiopathic hypersomnia. This poster will be presented at the 17th European Narcolepsy Days, taking place October 2–3, 2026, in Bern, Switzerland.

Poster details are listed below:

About HBS-301 
HBS-301 is an investigational, optimized, high-dose formulation of enteric-coated pitolisant tablets. HBS-301 is being developed in multiple tablet strengths up to 60 mg to treat excessive daytime sleepiness and other symptoms in patients with narcolepsy or idiopathic hypersomnia (IH). HBS-301 is currently being evaluated in two phase 3 clinical trials. The ONSTRIDE-1 study in adult patients with narcolepsy and the ONSTRIDE-2 study in adult patients with IH. 

About Harmony Biosciences

Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.

Harmony Biosciences Investor Contact:

Brennan Doyle
484-566-3685
[email protected]

Harmony Biosciences Media Contact:

Cate McCanless
202-641-6086
[email protected]

• Peer-reviewed publication in Journal for ImmunoTherapy of Cancer reports median overall survival of 24.5 months in advanced non-small cell lung cancer (NSCLC) patients with inadequate response to immune checkpoint inhibitors (ICI)
  

NEEDHAM, Mass., Oct. 01, 2026 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced the publication of final phase 2a clinical trial results (NCT04495153) of aglatimagene besadenovec (aglatimagene) plus valacyclovir in patients with stage III/IV NSCLC who had shown inadequate response to ICI. The trial demonstrated a median overall survival (mOS) of 24.5 months in the evaluable population, substantially exceeding historical benchmarks for standard-of-care docetaxel chemotherapy in this patient population.

The data is published in the Journal for ImmunoTherapy of Cancer, a leading peer-reviewed oncology journal, providing independent validation of the clinical significance of aglatimagene in patients with advanced NSCLC with an inadequate response to ICI.

Patients with unresectable stage III/IV NSCLC who progress on ICI face limited treatment options and poor survival outcomes. Current standard of care with docetaxel chemotherapy yields a median overall survival of only 9.8 to 11.8 months in this population.^1,2 The phase 2a trial enrolled 46 evaluable patients receiving two courses of aglatimagene plus valacyclovir in combination with continued ICI therapy (per protocol population). Among patients with progressive disease at baseline despite ICI treatment (cohort 2, n=41), mOS was 21.5 months. Notably, 37% of patients with progressive disease on ICI remained alive beyond 24 months at the time of data cutoff, demonstrating a prolonged survival tail not typically observed in this setting.

Non-squamous NSCLC has also emerged as a key predictor of enhanced clinical benefit. In the evaluable population of patients with non-squamous histology and progressive disease on ICI (n=33), mOS reached 25.4 months, with 14 of 15 patients surviving beyond 24 months and 9 of 9 patients surviving beyond 30 months having non-squamous disease. Exploratory analysis in the intention-to-treat cohort of non-squamous patients showed mOS of 16.7 months, still longer than the 12.3-month benchmark reported with docetaxel in this setting in published trials.

Mechanistic studies revealed systemic immune activation following treatment. Among evaluable patients with >1 lesion (n=35), 69% exhibited systemic clinical response with reduction of uninjected lesions, indicating an abscopal response. Biomarker analysis demonstrated increased cytotoxic T cell infiltration in tumor tissue, expansion of activated CD8+ effector and central memory T cells in peripheral blood, and elevated serum levels of granzymes after the second aglatimagene injection, with changes most pronounced following the second administration. Multi-omics factor analysis identified coordinated immune activation patterns associated with improved survival. Patients who survived beyond 24 months exhibited significantly higher levels of key immune markers, including granzyme B and granzyme H, compared to those who died earlier.

Treatment with aglatimagene plus valacyclovir was generally well tolerated, with the most common adverse events being mild flu-like symptoms (fatigue, nausea, pyrexia) that were predominantly grade 1 and 2. Grade 3 treatment-related adverse events were reported in 13.7% of patients. No dose-limiting toxicities or unexpected safety signals were identified during extended follow-up.

“These peer-reviewed results confirm that aglatimagene has the potential to extend survival for patients with advanced non-small cell lung cancer who have limited options after immune checkpoint inhibitors fail to control their cancer,” said Charu Aggarwal, MD, MPH, Leslye Heisler Professor of Medicine at the University of Pennsylvania’s Perelman School of Medicine and lead investigator of the trial. “The magnitude of benefit observed, particularly in patients with non-squamous disease, is striking, and represents an important potential advance for this patient population.”

Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel commented, “Aglatimagene’s ability to reinvigorate anti-tumor immunity in checkpoint-refractory patients through a systemic immune response, combined with its favorable safety profile, positions this approach as a potentially transformative option for patients with limited therapeutic alternatives. These results support the advancement of our pivotal phase 3 AURORA trial, which is enrolling patients globally.”

The global phase 3 AURORA trial is enrolling patients across approximately 150 sites worldwide. The trial is evaluating aglatimagene plus valacyclovir in combination with continued pembrolizumab versus standard-of-care docetaxel in patients with metastatic stage IV non-squamous NSCLC who have experienced disease progression despite prior pembrolizumab and platinum-based chemotherapy.

About aglatimagene besadenovec

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several nonclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority for any use.

About Candel Therapeutics

Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA and published in The Lancet Oncology. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC.

Linoserpaturev is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma, evaluating the effects of repeat linoserpaturev injections. Initial results were published in Nature and Science Translational Medicine and linoserpaturev received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.

For more information about Candel, visit: www.candeltx.com.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat, solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s nonclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Investor Contact

Theodore Jenkins
Vice President, Investor Relations, and Business Development
Candel Therapeutics, Inc.
[email protected]

Media Contact

Ben Shannon
ICR Healthcare
[email protected]

¹ Paz-Ares LG et al. J Clin Oncol 2024;42:2860-2872
² Ahn MJ et al. J Clin Oncol 2024;43:260-272

NEW YORK, Oct. 01, 2026 (GLOBE NEWSWIRE) — StepStone Group Inc. (Nasdaq: STEP), a leading global private markets investment firm, today announced that Yoshitaka Todoroki has joined the firm as a Vice Chairman, focusing on strategic initiatives in Japan and the broader Asia region.

Mr. Todoroki joins StepStone following a distinguished career in private markets investing spanning more than 30 years. Most recently, he served as Executive Director of the Private Market Investment Department at Japan’s Government Pension Investment Fund (GPIF). Throughout his decade-long tenure at GPIF, Mr. Todoroki led the development of the pension fund’s private markets investment program across private equity, infrastructure and real estate. He established its investment strategy and frameworks, risk monitoring and management procedures, and relationships with general partners and other institutional investors globally.

Scott Hart, StepStone CEO, said, “Yoshitaka Todoroki brings tremendous experience and perspective from more than three decades investing across private markets, including helping to build and lead the private markets program for one of the world’s largest institutional investors. His firsthand perspective as an asset-owner and understanding of how investments across private asset classes fit within a broader portfolio will be highly valuable to our clients. We are delighted to welcome him to StepStone as we continue to grow our platform across Asia and beyond.”

Mr. Todoroki said, “Having spent much of my career investing in private markets as an institutional investor, I have long appreciated the importance of strong partnerships, informed judgment and a holistic approach to portfolio construction. StepStone’s deep investment expertise, global perspective and data-driven insights create a powerful platform for serving institutional investors. I am pleased to join the firm and look forward to working with Scott and the broader team to support StepStone’s clients and continued growth in the region.”

Prior to joining GPIF in 2016, Mr. Todoroki was Head of the Alternative Investment Group at Sumitomo Mitsui Asset Management. Earlier in his career, he held investment roles at Sumitomo Mitsui Banking Corporation, MassMutual Life Insurance Japan and The Sumitomo Trust and Banking Co.

Mr. Todoroki holds a Bachelor of Commerce from Hitotsubashi University and completed the Investment Management Programme at London Business School.

About StepStone Group

StepStone Group Inc. (Nasdaq: STEP) is a global private markets investment firm focused on providing customized investment solutions and advisory and data services to its clients. As of June 30, 2026, StepStone was responsible for approximately $913 billion of total capital, including $245 billion of assets under management.

StepStone’s clients include some of the world’s largest public and private defined benefit and defined contribution pension funds, sovereign wealth funds and insurance companies, as well as prominent endowments, foundations, family offices and private wealth clients, which include high-net-worth and mass affluent individuals.

StepStone partners with its clients to develop and build private markets portfolios designed to meet their specific objectives across the private equity, infrastructure, private debt and real estate asset classes.

Contacts

Shareholder Relations:

Seth Weiss
[email protected]
1-212-351-6106

Media:

Jordan Niezelski / Maggie Duffy
Edelman
[email protected]

LOUISVILLE, Ky., Oct. 01, 2026 (GLOBE NEWSWIRE) — BrightSpring Health Services, Inc. (“BrightSpring” or the “Company”) (NASDAQ: BTSG) announced today that it plans to release its third quarter 2026 financial results on Friday, October 30, 2026, prior to the Company’s earnings conference call, which will be held at 8:30 a.m. ET on the same day.

To participate in the conference call, please register here before the 8:30 a.m. ET start. A live and archived webcast of the call will be available on the Company’s investor relations website at https://ir.brightspringhealth.com under the “Events & Presentations” section, where related presentation materials will be posted prior to the conference call. The webcast may be accessed directly here.

About BrightSpring Health Services

BrightSpring Health Services provides complementary home- and community-based health solutions for medically complex populations in need of specialized and/or chronic care. Through the Company’s service lines, including pharmacy, home health care, and rehabilitation, we provide comprehensive and more integrated care and clinical solutions in all 50 states to over 485,000 customers, clients and patients daily. BrightSpring has consistently demonstrated strong and industry-leading quality metrics across its services lines, while improving the health and quality of life for high-need individuals and reducing overall healthcare system costs.

Contact

Investor Relations:

David Deuchler, CFA
SVP, Strategic Finance & Investor Relations
Executive Director, BrightSpring Health Foundation
[email protected]
917.209.5605

Media Contact:

Leigh White
Vice President, Communications & PR
[email protected]
502.630.7412

• Interim analysis results from clinical study evaluating tafenoquine in severe babesiosis (NCT06207370) to be disclosed on October 6, 2026.
• Key Opinion Leader investor webinar scheduled for October 6, 2026, featuring leading babesiosis experts Dr. Peter Krause and Dr. Edouard Vannier.

WASHINGTON, Oct. 01, 2026 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company that develops and commercializes new medicines for vector-borne disease, today announced that it will disclose the outcome of the interim analysis from its clinical study evaluating tafenoquine in patients hospitalized with severe babesiosis (NCT06207370) on October 6, 2026.

In conjunction with the data release, 60 Degrees will host a Key Opinion Leader (KOL) investor webinar on Tuesday, October 6, 2026. The webinar will highlight the substantial unmet medical need for new therapeutic options in relapsing and treatment-refractory babesiosis, review the clinical data from Company’s hospital and expanded access studies and the literature, and discuss the potential role of tafenoquine in addressing recurrent tick-borne infections.

Webinar Featured Speakers

• Peter J. Krause, M.D., Senior Research Scientist in the Department of Epidemiology and Public Health at Yale School of Public Health and Yale School of Medicine. Dr. Krause is an internationally recognized authority on human babesiosis who led the original antibiotic treatment trial establishing atovaquone/azithromycin as standard-of-care 25 years ago.
• Edouard Vannier, Ph.D., Assistant Professor of Medicine at Tufts Medical Center / Tufts University School of Medicine, a leading clinical researcher specializing in the pathogenesis, diagnosis, and treatment of Babesia microti infection.

During the presentation, the speakers will address the clinical burden of persistent babesiosis in immunocompromised hosts, treatment limitations under current guidelines, and the mechanistic rationale for tafenoquine combination therapy. A live question-and-answer session will follow the presentation.

No FDA-approved treatment or vaccine exists for babesiosis. Tafenoquine is not currently approved by the FDA for the treatment and prevention of babesiosis. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA® (tafenoquine).

Webinar Details

• Date: Tuesday, October 6, 2026
• Time: 11:00 a.m. ET
• 
  Registration / Webcast Link
  

About 60 Degrees Pharmaceuticals, Inc.

60 Degrees Pharmaceuticals, Inc., founded in 2010, develops and commercializes new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention in 2018 and currently has active clinical trials underway for babesiosis, an emerging tick-borne disease. ARAKODA is sold commercially in the U.S. and Australia. 60 Degrees also collaborates with prominent research and academic organizations in the U.S. and Australia to advance science around vector-borne disease. The Company is headquartered in Washington, D.C., with a subsidiary in Australia. Learn more at www.60degreespharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on March 30, 2026, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized, or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contacts

Media Contact:

Kristen Landon
[email protected]

Investor Contact:

Patrick Gaynes
[email protected]