60 Degrees Pharmaceuticals Announces Clinical Site Now Open for Patient Enrollment for the B-FREE Chronic Babesiosis Study at Mount Sinai Icahn School of Medicine




60 Degrees Pharmaceuticals Announces Clinical Site Now Open for Patient Enrollment for the B-FREE Chronic Babesiosis Study at Mount Sinai Icahn School of Medicine

• 90-day trial will measure change in general fatigue in patients with chronic babesiosis following tafenoquine treatment
• Study will run approximately 12 months and enroll up to 100 patients
• Internal estimates of the unmet medical need are between 4,400 and 190,000 cases annually, with no existing FDA-approved treatment for babesiosis

WASHINGTON, Nov. 21, 2025 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, announced today that the central study site for the Company’s B-FREE Chronic Babesiosis Study, the Cohen Center for Recovery from Complex Chronic Diseases at Mount Sinai Icahn School of Medicine, is open for patient enrollment. The study is the first to evaluate a therapeutic for chronic babesiosis and will run for approximately 12 months.

The B-FREE Chronic Babesiosis Study (NCT06656351) is a Phase 2 open-label study that will evaluate the efficacy (and safety) of the ARAKODA^® regimen of tafenoquine over 90 days for resolution of severe fatigue, and parasite eradication in patients diagnosed with chronic babesiosis.

For the purposes of the study, chronic babesiosis is defined as a condition affecting a patient who has experienced disabling fatigue for at least six months, with other symptoms of babesiosis, and laboratory confirmation of exposure to Babesia parasites in the prior 12 months. No treatment for babesiosis has been approved by the U.S. Food and Drug Administration (FDA) to date.

The unmet medical need from current claims data suggests approximately 4,400 diagnosable cases of chronic babesiosis with severe fatigue in the U.S. each year, while internal market research indicates the number could be as high as 190,000 if molecular testing confirms broader prevalence. One of the central aims of the B-FREE study is to establish whether Babesia infection in patients with a chronic babesiosis diagnosis can be confirmed using validated molecular tests, which will help determine the true size of the patient population. By clarifying whether the market size falls closer to the conservative estimate, or approaches the higher bound, the study is designed not only to advance clinical science but also to quantify the scope of unmet medical need.

“The B-FREE study will help us understand both the potential of tafenoquine to improve patients’ lives and the true scope of chronic babesiosis, which remains poorly defined,” said 60 Degrees Pharmaceuticals, Inc. Chief Executive Officer, Geoff Dow, PhD. “We are delighted to get this important babesiosis study underway.”

“At Mount Sinai, we see the toll chronic babesiosis takes on patients who have few options and little recognition of their illness,” commented David Putrino, Principal Investigator. “This study is an important step toward better understanding the diagnosis of chronic babesiosis and developing new treatments.”

“I’m incredibly proud to be part of the tafenoquine trial team,” said CoRE Scientific Director Amy Proal, PhD. “Patients with chronic Babesiosis have been waiting far too long for an approved treatment option. Now there is hope that one may be on the horizon. This trial marks a major step forward in working to identify targeted care for an underserved patient population.”

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA^®. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the United States Food and Drug Administration for such an indication.

About the B-FREE Chronic Babesiosis Study

B-FREE, an open-label study (NCT06656351), will evaluate the efficacy and safety of the ARAKODA^® (tafenoquine) regimen over 90 days, treating patients with a diagnosis of chronic babesiosis. The primary endpoint will be resolution of fatigue assessed using a patient-reported outcome measure (the multi-dimensional fatigue inventory general fatigue subscale) at Day 90 compared with baseline. Participants will have experienced significant functional impairment for at least six months. Tafenoquine (2 x 100 mg tablets) will be self-administered orally with food on Days 1, 2, 3, 4, then weekly thereafter for a total 12-week treatment period. Weekly treatment will start on Day 11 and end on Day 89.

The study will enroll and treat up to 100 patients, with the goal being completion by at least 16 patients for whom Babesia infection was confirmed at baseline using the FDA-licensed RNA amplification test used by the American Red Cross to screen blood donations. That test, which is not available for patient care, has the greatest sensitivity and is therefore the most stringent. Accordingly, B-FREE Study data will yield an estimate of the proportion of chronic babesiosis patients for whom it is possible to objectively confirm infection.

As all screening is being conducted outside of New York, in order to remain in compliance with state law and to avoid inadvertently alerting patients to their diagnostic results, we plan to disclose that the first case has been confirmed only after at least one enrolled patient tests negative and at least one enrolled patient tests positive. The overall proportion of patients for whom Babesia infection was confirmed will be disclosed once the minimum number of patients has been enrolled.

At baseline, and approximately monthly for six months, patients will be screened using the FDA-licensed RNA amplification test, and two CLIA-validated RT-PCR assays that are commercially available for patient care. Those screening data will provide estimates of the rate at which broadly available commercial assays can detect confirmed infections and will be disclosed once we have completed the minimum enrollment in the study. This longitudinal molecular testing will also reveal the extent to which Babesia infections in this patient population can be eradicated with tafenoquine.

Clinical Babesiosis Studies Sponsored by 60 Degrees Pharmaceuticals

In addition to B-FREE (NCT06656351), two other 60 Degrees Pharmaceuticals-sponsored clinical trials (NCT06478641, NCT06207370) are now underway to evaluate tafenoquine’s safety and efficacy in treating humans diagnosed with babesiosis.

NCT06207370 is a double-blind randomized multi-site placebo-controlled trial in hospitalized patients which requires a minimum of N=24 patients to be enrolled before an interim data analysis can be conducted. At the end of the 2025 tick season, a total of 19 patients had been randomized. An interim analysis is anticipated in the second half of 2026 after the remaining patients have been enrolled during the 2026 tick season (which starts in June, and ends in early October).

NCT06478641 is an open label, expanded access study of tafenoquine (up to 12 months duration) combined with conventional treatments in high-risk relapsing babesiosis patients in whom prior treatment failed. The study does not have a pre-determined minimum sample size. One patient completed the study in October 2025, and the remaining two patients currently enrolled will complete the study between January and September 2026.

In early 2026, the Company will request a Type B meeting with the FDA to discuss requirements for submitting a supplemental New Drug Application (sNDA).

About Babesiosis
Babesiosis is a tick-borne illness caused by Babesia parasites that develop and multiply in red blood cells. Its symptoms include fevers, chills, sweats, and fatigue, and in severe cases, can be life-threatening in elderly and immunosuppressed patients. Incidence of the disease is rapidly rising, particularly in the Northeast. Transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease, babesiosis is an orphan disease. Insurance claims research commissioned by the Company suggest that the minimum annual incidence of babesiosis is at least 25,000 cases per year, although the true number may be much larger than this. Currently no FDA-approved treatment exists specifically for babesiosis.

Babesia infection persists for months, and potentially for several years following a tick bite. In patients with risk factors (e.g., immunosuppression, age, asplenia), persistent infection may result in recurring clinical relapses of the disease, each with the potential for hospitalization. In individuals without such known risk factors, it has been generally assumed that persistent infection is not clinically meaningful. However, the potential clinical significance of persistent infection in individuals with dysregulated immune systems (e.g., chronic tick-borne diseases, long covid and other long syndromes) has not been studied, but it is hypothesized to complicate recovery from other chronic symptoms. The lack of sufficiently sensitive, FDA-approved diagnostics has stymied prior efforts to study this problem.

About ARAKODA^® (tafenoquine)
Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA^®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months.

Tafenoquine was discovered by Walter Reed Army Institute of Research and the current study was funded by the United States Army Medical & Materiel Development Activity. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA^® and in Australia as KODATEF^®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug.

According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less-frequent dosing for prophylaxis for malaria. ARAKODA^® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA^® 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.

ARAKODA^® (tafenoquine) Important Safety Information

ARAKODA^® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

Contraindications

ARAKODA^® should not be administered to:

• Glucose-6-phosphate dehydrogenase (“G6PD”) deficiency or unknown G6PD status;
• Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if
• G6PD status is unknown;
• Patients with a history of psychotic disorders or current psychotic symptoms; or
• Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA®.

Warnings and Precautions

Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA^® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.

G6PD Deficiency in Pregnancy or Lactation: ARAKODA^® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA^® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA^® through breast milk. Check infant’s G6PD status before breastfeeding begins.

Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.

Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA^® therapy and evaluation by a mental health professional as soon as possible.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA^®. If hypersensitivity reactions occur, institute appropriate therapy.

Delayed Adverse Reactions: Due to the long half-life of ARAKODA^® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.

Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams, and anxiety.

Drug Interactions

Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.

Use in Specific Populations

Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA^®. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODA^® is located here.

About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing 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. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a subsidiary in Australia. Learn more at www.60degreespharma.com.

The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.

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 or patient recruitment in our trials might be slow or negligible; 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 April 1, 2024, 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.

Media Contact:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330

Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com
(310) 989-5666

Adlai Nortye to Participate in Upcoming Investor Conferences




Adlai Nortye to Participate in Upcoming Investor Conferences

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Nov. 21, 2025 (GLOBE NEWSWIRE) — Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that members of its management team are scheduled to participate in the following investor conferences:

The 8^th Annual Evercore Healthcare Conference
Format: Fireside Chat
Host: Jonathan Miller
Date and Time: Tuesday, December 2, 2025; 4:15 pm – 4:35 PM EST.
Location: Sevilla A, Track 2, the Loews Coral Gables Hotel in Coral Gables, Florida.

The 36^th Oppenheimer Annual Healthcare Life Sciences Conference
Format: Virtual Presentation and 1-on-1 meetings
Date and Time: February 25-26, 2026

About Adlai Nortye

Adlai Nortye (NASDAQ: ANL) is a global clinical-stage company at the forefront of discovering and developing innovative cancer therapies. Leveraging our dual R&D presence in the U.S. and China, we are building a robust pipeline of drug candidates focused on two key areas where we believe we can make a significant difference. (1) Next-generation cancer immunotherapies: our candidates, AN8025 (a tri-functional fusion protein of αPD-L1 x CD86 variant x LAG3 variant), a T-cell and antigen-presenting cell modulator, and AN4005 (a first-in-class oral small-molecule PD-L1 inhibitor), are designed to activate cancer immunity in novel ways. (2) RAS-targeting therapies: we are tackling RAS-driven cancers with AN9025, an oral pan-RAS(ON) inhibitor, and AN4035, a CEACAM5-targeting ADC delivering a potent pan-RAS(ON) inhibitor directly to tumors.

Forward-Looking Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets” and similar statements. Among other things, statements that are not historical facts, including statements about the Company’s beliefs and expectations, the business outlook and quotations from management in this announcement, as well as the Company’s strategic and operational plans, are or contain forward-looking statements.

The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. Factors that could cause the Company’s actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of the Company’s preclinical studies, clinical trials and other therapeutic candidate development efforts; the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results will be predictive of real-world results; the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of the Company’s therapeutic candidates; the Company’s ability to establish, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; the implementation of the Company’s business model and strategic plans for its business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the PRC and United States or elsewhere. Further information regarding these and other risks is included in the Company’s filings with the SEC. All information provided in this announcement and in the attachments is as of the date of this announcement, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Company contact:
Investor Relations
Email: ir@adlainortye.com

XOMA Royalty Announces Closing of Transactions to Acquire LAVA Therapeutics N.V.




XOMA Royalty Announces Closing of Transactions to Acquire LAVA Therapeutics N.V.

EMERYVILLE, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) — XOMA Royalty Corporation (“XOMA Royalty”) (Nasdaq: XOMA) today announced it has successfully completed its previously announced acquisition of all the outstanding common shares of LAVA Therapeutics N.V. (“LAVA”) (NASDAQ: LVTX) with a nominal value of €0.12 per share (“Shares”).  LAVA shareholders received $1.04 in cash per Share and a non-transferrable contingent value right (“CVR”) per Share representing the right to receive certain cash payments, including (A) the right to receive, among other things, 75% of any net proceeds related to LAVA’s two partnered assets plus 75% of any net proceeds from any out license or sale of LAVA’s unpartnered programs plus (B) the right to receive up to approximately $0.23 per CVR depending on the final determination after closing of certain potential liabilities.

“The acquisition of LAVA Therapeutics reinforces XOMA’s philosophy of ‘strength in numbers’, adding two early-stage bispecific antibodies in collaboration with well-established oncology partners, Johnson and Johnson and Pfizer,” stated Owen Hughes, Chief Executive Officer of XOMA Royalty.  “The combination of future milestones and royalties from the LAVA programs has the potential to drive significant value creation for the LAVA CVR holders and XOMA Royalty over time.”

The initial offer period and subsequent offer period expired one minute after 11:59 p.m. Eastern Time on Wednesday, November 12, 2025, and one minute after 11:59 p.m. Eastern Time on Thursday, November 20, 2025 (the “Final Expiration Date”), respectively.  As of the Final Expiration Date, a total of 23,956,708 Shares were validly tendered, and not validly withdrawn, representing approximately 91.1% of the outstanding Shares as of the Final Expiration Date. 

Following the acceptance for payment of all Shares tendered in the subsequent offering period, LAVA consummated a corporate reorganization resulting in XOMA Royalty acquiring 100% of the shares in LAVA’s successor and all then-remaining LAVA shareholders (other than XOMA Royalty) receiving the same cash and CVR consideration per share as is provided in the tender offer, subject to applicable withholding taxes.  Prior to the opening of trading on November 21, 2025, public trading of the Shares was suspended, and LAVA intends promptly to cause such Shares to be delisted from Nasdaq and deregistered under the Securities Exchange Act of 1934, as amended.

Advisors
XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP and Loyens & Loeff N.V, who acted as U.S. and Dutch legal advisors, respectively.  Leerink Partners acted as exclusive financial advisor to LAVA, and Cooley LLP and NautaDutilh N.V. served as U.S. and Dutch legal advisor, respectively, to LAVA.

About XOMA Royalty Corporation
XOMA Royalty is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health.  XOMA Royalty acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies.  When XOMA Royalty acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes.  XOMA Royalty has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate).  For more information about XOMA Royalty and its portfolio, please visit www.xoma.com or follow XOMA Royalty Corporation on LinkedIn.

XOMA Royalty Forward-Looking Statements/Explanatory Notes
Certain statements contained in this press release are forward-looking statements, including statements regarding the payment and timing of payment of the Offer to former LAVA common stockholders, the ability and timing of delisting of LAVA common stock, the ability of XOMA Royalty to monetize LAVA’s programs for the benefit of XOMA Royalty and LAVA shareholders, the ability of XOMA Royalty to obtain a final determination of any potential liabilities after closing, and the ability to achieve any dispositions within the disposition period under the CVR, including the new form thereto.  In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “approximately,” “look to,” “plan,” “expect,” “may,” “will,” “could” or “should,” the negative of these terms or similar expressions.  These forward-looking statements are not a guarantee of XOMA Royalty’s performance, and you should not place undue reliance on such statements.  These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks including the risk that XOMA Royalty does not achieve the anticipated benefits from LAVA’s two partnered assets or the potential out license or sale of LAVA’s unpartnered programs, the risk that XOMA Royalty is unable to enter into dispositions related to the LAVA programs, the risk that XOMA Royalty is unable to obtain a timely or satisfactory final determination of any potential liabilities after closing, and risks that the conditions to the closing the transaction in the Purchase Agreement and Amendment are not satisfied.  Other potential risks to XOMA Royalty meeting these expectations are described in more detail in XOMA Royalty’s most recent filing on Form 10-Q and in other filings with the Securities and Exchange Commission.  Any forward-looking statement in this press release represents XOMA Royalty’s beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date.  XOMA Royalty disclaims any obligation to update any forward-looking statement, except as required by applicable law.

EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development.  Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development.

Inotiv, Inc. to Report Fiscal 2025 Fourth Quarter and Full Year Financial Results and Host Conference Call on Wednesday, December 3, 2025




Inotiv, Inc. to Report Fiscal 2025 Fourth Quarter and Full Year Financial Results and Host Conference Call on Wednesday, December 3, 2025

WEST LAFAYETTE, Ind., Nov. 21, 2025 (GLOBE NEWSWIRE) — Inotiv, Inc. (NASDAQ: NOTV) (the “Company”, or “Inotiv”), a leading contract research organization specializing in nonclinical and analytical drug discovery and development services and research models and related products and services, today announced that it will issue its financial results for the fiscal 2025 fourth quarter and full year ended September 30, 2025, on Wednesday, December 3, 2025, after the close of the stock market. The Company will host a conference call that same day at 4:30 p.m. Eastern Time to discuss the results.

Interested parties may participate in the call by dialing:

• 1-800-225-9448 (Domestic)
• 1-203-518-9708 (International)
• INOTIV (Conference ID)

The live conference call webcast will be accessible in the Investors section of the Company’s web site and directly via the following link:

https://viavid.webcasts.com/starthere.jsp?ei=1743648&tp_key=169e7235ab

For those who cannot listen to the live broadcast, an online replay will be available in the Investors section of Inotiv’s web site at: https://ir.inotiv.com/events-and-presentations/default.aspx.

About Inotiv
Inotiv, Inc. is a leading contract research organization dedicated to providing nonclinical and analytical drug discovery and development services and research models and related products and services. The Company’s products and services focus on bringing new drugs and medical devices through the discovery and preclinical phases of development, all while increasing efficiency, improving data, and reducing the cost of taking new drugs and medical devices to market. Inotiv is committed to supporting discovery and development objectives as well as helping researchers realize the full potential of their critical research and development projects, all while working together to build a healthier and safer world. Further information about Inotiv can be found here: https://www.inotiv.com/.

This release may contain forward-looking statements that are subject to risks and uncertainties including, but not limited to, risks and uncertainties related to the Company’s assessment of its cybersecurity incident, ongoing or potential impacts, and efforts of the Company related to the incident, the Company’s ability to comply with covenants under its credit agreement, compliance with the Resolution and Plea Agreements with the U.S. Department of Justice and the expected impacts on the Company related to the compliance plan, compliance monitor, and the expected financial commitments, changes in the market and demand for the Company’s products and services, the development, marketing and sales of products and services, changes in technology, industry and regulatory standards, the timing of acquisitions and the successful closing, integration and business and financial impact thereof, governmental regulations, inspections and investigations, claims and litigation against or involving the Company, its business and/or its industry, the impact of site closures and consolidations, expansion and related efforts, and various other market and operating risks, including those detailed in the Company’s filings with the U.S. Securities and Exchange Commission.

Actimed Therapeutics Announces Important Licensing Agreement with Mankind Pharma




Actimed Therapeutics Announces Important Licensing Agreement with Mankind Pharma

• Covers exclusive rights to S-pindolol, the novel therapy in development for the treatment of cachexia, in India and South Asia
• Represents a major step in the mission of Actimed to bring the first globally approved cancer cachexia product to patients in need

London, UK – 21^st Novemeber 2025. Actimed Therapeutics Ltd (“Actimed”), a UK based clinical stage specialty pharmaceutical company focused on bringing innovation to the treatment of cancer cachexia and other muscle wasting disorders, today announces that it has entered into a licensing agreement with Mankind Pharma Limited (“Mankind”), one of India’s leading innovative pharmaceutical companies and a shareholder in Actimed, granting Mankind exclusive rights to develop and commercialise Actimed’s products for use in the treatment and/or prevention of cachexia in India and South Asian territories.

Under the agreement, Mankind gains exclusive territorial product rights in the Indian subcontinent, comprising India, Bangladesh, Bhutan, Nepal, Sri Lanka and Myanmar. The license covers Actimed’s patents, know-how and any future related patents, enabling Mankind to develop, manufacture and commercialise the products in the territory under its own trademarks. The agreement is limited to the field of use in the treatment and/or prevention of cachexia, and Mankind will be responsible for all associated development, manufacturing and sales and marketing costs.

The licensed products include those developed based on Actimed intellectual property and patents within the field of use, including the Actimed programmes for S-pindolol benzoate (ACM-001.1), which Actimed plans to take into the Phase 2b/3 clinical development stage for cancer cachexia. Subject to successful completion and regulatory approvals, the product will be commercialised by Mankind in the above-mentioned territories. The Commercial terms of the agreement are not being disclosed.

Robin Bhattacherjee, Actimed CEO, commented: “We are delighted to enter into this agreement with Mankind. Cachexia is a debilitating condition for which there are currently no globally approved therapies. By combining the Actimed cachexia product pipeline with Mankind’s strong development and commercial capabilities in its key markets, we are taking a major step forward in our aim to deliver meaningful treatment options to cachexia patients globally.”

Atish Majumdar, Senior President (Sales & Marketing) at Mankind Pharma and Non-Executive Director, Actimed, added: “Mankind has been a long-term supporter and shareholder of Actimed, and we are proud to deepen our partnership through this strategic licensing agreement. This collaboration reflects our shared commitment to advancing innovative therapies and improving the lives of patients affected by cachexia across the Indian subcontinent. We have strong confidence in Actimed’s vision, leadership, and development expertise, and we are proud to partner with them on this important journey.”

***

About Actimed Therapeutics 
Actimed Therapeutics is a clinical stage specialty pharmaceutical company focused on bringing innovation to the treatment of muscle wasting disorders to transform the care of an underserved and vulnerable patient population.

The lead area of focus for Actimed is specifically in cachexia. Cachexia is a wasting disease that is associated with cancer and other serious chronic illnesses and with significant morbidity and mortality. A significant number of cancer patients suffer from cachexia¹ and it is estimated that cachexia is responsible for up to 20% of all cancer deaths². A recent meta-analysis demonstrated that cachexia was associated with an 82% higher relative risk of mortality in patients with NSCLC versus no cachexia³.

Despite its prevalence and devastating clinical effects, there is no globally approved drug for the treatment or prevention of cancer-related cachexia. 

Actimed is currently preparing for further clinical studies of its lead product ACM-001.1. (S-pindolol benzoate) which is an anti-catabolic and pro-anabolic transforming agent (ACTA) targeting multiple pathways that drive cancer cachexia. Previous studies with S-pindolol have generated promising Phase 2a proof of concept data, the ACT-ONE Trial⁴, in cachexia patients and Actimed has conducted a pharmacokinetic and pharmacodynamic (PK/PD) study of S-pindolol benzoate to characterise this new salt form⁵.  ACM001.1 has achieved Investigational New Drug (IND) status from FDA.

Actimed also owns the global rights to its second asset, S-oxprenolol (ACM-002), which is being developed by the Company for the muscle wasting seen in amyotrophic lateral sclerosis (ALS) where loss of body mass and muscle wasting may impact survival⁶. Actimed was granted US Orphan Drug Designation to S-oxprenolol for the treatment of ALS in 2024. Actimed has licensed the global rights to develop and commercialise S-oxprenolol for cancer cachexia and any other indications outside of ALS to US company Faraday Pharmaceuticals.

FOR MORE INFORMATION
Actimed Therapeutics
www.actimedtherapeutics.com 

MEDiSTRAVA
Frazer Hall, Erica Hollingsworth
Tel: +44 (0)203 928 6900
Email: actimed@medistrava.com

About Mankind Pharma

Mankind Pharma (BSE: 543904 | NSE: MANKIND) is one of the largest pharmaceutical company in India, which focuses on the domestic market with its Pan India presence. Mankind operates at the intersection of the Indian pharmaceutical formulations and consumer healthcare sectors with the aim of providing quality products at affordable prices. The company is a leading player in the domestic pharmaceuticals business present across acute and chronic therapeutic areas including anti-infectives, cardiovascular, gastrointestinal, antidiabetic, neuro/CNS, gynecology, VMN and respiratory, among others with a strategy to increase chronic presence going ahead. In the consumer healthcare business, the company operates in the condoms, pregnancy detection, emergency contraceptives, antacid powders, vitamin and mineral supplements and anti-acne preparations categories, among others, with several category-leading brands. Following the acquisition of Bharat Serums and Vaccines Limited, Mankind Pharma has further strengthened its leadership in the domestic women’s health segment. Mankind’s distribution network includes a robust field force of 17,700+ professionals, and a reach extending to over five lakh doctors across urban and rural markets. The company has 32 manufacturing facilities in India manufacturing a wide range of dosage forms, including tablets, capsules, syrups, vials, ampoules, blow fill seal, soft and hard gels, eye drops, creams, contraceptives and other over-the-counter products. Mankind has a consistent track record of product innovation through 6 dedicated R&D facilities backed by more than 730 scientists.

For more information, visit www.mankindpharma.com or contact:

Natasha Raj – 9205057627 – natasha.raj@mankindpharma.com
Apoorva Sharma – 9999739452 – apoorva.sharma@adfactorspr.com
_________________________
¹ Anker M et al., J. Cachexia, Sarcopenia and Muscle; 2019: 10: 22 – 24
² Argilés JM et al, Nat Rev Cancer 2014; 14:754-62
³ Bonomi P. et al. The mortality burden of cachexia in patients with non-small-cell lung cancer: A meta-analysis; International Conference of Sarcopenia, Cachexia and Wasting Disorders, June 17 – 18 2023, Stockholm, abstract 2-18, page 139
⁴ Coats et al. J Cachexia Sarcopenia Muscle 2016;7:355-65.
⁵Misselwitz et al. Journal of Cachexia, Sarcopenia and Muscle, 2025 Feb;16(1):e13651. ⁶ Wolf J et al., PMID 28184974 DOI: 10.1007/s00115-117-0293

Anaptys Announces $100 Million Stock Repurchase Plan




Anaptys Announces $100 Million Stock Repurchase Plan

SAN DIEGO, Nov. 21, 2025 (GLOBE NEWSWIRE) — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that its Board of Directors has authorized an amended Stock Repurchase Plan under which the Company may repurchase up to $100.0 million of the Company’s outstanding common stock, par value $0.001 per share. This amendment is in addition to the $6.4 million that remained as of Nov. 20, 2025 under the current $75.0 million Stock Repurchase Plan of which Anaptys has repurchased a total of 3,443,188 shares of common stock (11.2% shares outstanding before the start of this repurchase plan).

Excluding any additional potential purchases under this Stock Repurchase Plan, Anaptys anticipates ending 2025 with approximately $300 million in cash, cash equivalents and investments, including an anticipated accrual of a one-time $75 million commercial sales milestone in Q4 2025 due from GSK once Jemperli achieves $1 billion in worldwide net sales.

The shares may be repurchased from time to time in open market transactions, or other means in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 10b-18 of the Exchange Act. The timing, number of shares repurchased, and prices paid for the stock under this program will depend on general business and market conditions as well as corporate and regulatory limitations, prevailing stock prices, and other considerations. The Stock Repurchase Plan will expire on March 31, 2026, may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of common stock.

About Anaptys

Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. The company’s pipeline includes rosnilimab, a pathogenic T cell depleter, which has completed a Phase 2b trial for rheumatoid arthritis; ANB033, a CD122 antagonist, in a Phase 1b trial for celiac disease with plans to expand development into an additional indication; and ANB101, a BDCA2 modulator, in a Phase 1a trial. Anaptys has also discovered and out-licensed in financial collaborations multiple therapeutic antibodies, including a PD-1 antagonist (Jemperli (dostarlimab-gxly)) to GSK and an IL-36R antagonist (imsidolimab) to Vanda Pharmaceuticals. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn.

Anaptys recently announced the intent to separate its biopharma operations from its substantial royalty assets by year-end 2026, enabling investors to align their investment philosophies and portfolio allocation with the strategic opportunities and financial objectives of each company. Learn more here.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the company’s ability to execute the Stock Repurchase Plan, in whole or in part; year-end cash estimates; the potential to receive any additional milestones and royalties from the GSK collaboration, and the timing therefor; and expectations regarding the structure, infrastructure, timing and taxation of the proposed separation into two companies. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. 

Contact:
Nick Montemarano
Executive Director, Investor Relations
858.732.0178
investors@anaptysbio.com

Anaptys Initiates Litigation Against Tesaro, a GSK Subsidiary




Anaptys Initiates Litigation Against Tesaro, a GSK Subsidiary

SAN DIEGO, Nov. 21, 2025 (GLOBE NEWSWIRE) — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, announced it has filed a Verified Complaint in Delaware Chancery Court, requesting a court declaration that TESARO, Inc. (“Tesaro”) has materially breached the parties’ Collaboration and Exclusive License Agreement (“Collaboration Agreement”) and that GSK (Tesaro’s corporate parent) has tortiously interfered with the Collaboration Agreement. Anaptys has requested that the court declare that Anaptys is entitled to all rights and remedies under the Collaboration Agreement.

The Complaint contends that Tesaro breached, and GSK induced Tesaro to breach, multiple material Collaboration Agreement terms. Under these terms, Tesaro agreed that it would not conduct or participate in research, development, manufacturing or commercialization of any PD-1 antagonist other than those licensed by Anaptys to Tesaro. The Collaboration Agreement also provides that Tesaro will “use Commercially Reasonable Efforts to . . . obtain the optimum commercial return for [Jemperli] in all major markets throughout the world.”

Despite these obligations, the Complaint contends that Tesaro (i) violated its exclusivity obligations by participating in past, ongoing, and upcoming governed clinical trials with PD-1 antagonists that compete with Jemperli, including Keytruda, and (ii) failed to use Commercially Reasonable Efforts to obtain the “optimum commercial return” for Jemperli by, among other things, participating in a course of conduct with GSK to favor GSK’s antibody-drug conjugate (ADC) product candidates, including by pairing those ADCs with PD-1 antagonists that directly compete with Jemperli.

In 2020, Anaptys similarly filed a complaint against GSK regarding breaches of its obligations under the Collaboration Agreement. Those breaches at the time related to GSK’s planned clinical trial of Zejula, another of GSK’s oncology programs, in combination with Keytruda, without the consent of Anaptys. This planned trial violated Tesaro’s exclusivity obligations. This complaint resulted in a settlement that included a cash payment, a royalty on Zejula and a substantial increase in royalties on sales of Jemperli due to Anaptys.

While Anaptys had approached Tesaro to engage in good faith discussions to potentially resolve these claims, on Nov. 20, 2025, Tesaro, without notice, initiated a lawsuit against Anaptys. Tesaro’s complaint includes requests for injunctive relief, claiming that Anaptys has breached the Collaboration Agreement. Tesaro’s claim for breach is predicated on an allegation that Anaptys has improperly alleged that Tesaro had breached the Collaboration Agreement. Tesaro seeks to improperly restrain Anaptys from exercising its legal rights under the Collaboration Agreement in violation of Delaware’s anti-SLAPP statute and other legal protections. Anaptys contends that Tesaro’s claims are entirely without merit and intends to pursue all appropriate legal remedies against Tesaro, including dismissal of such claims at the earliest opportunity and the potential for additional litigation.

The parties have agreed to request an expedited schedule with the Delaware Chancery Court, with trial anticipated in July 2026.

Milestone and royalty payment obligations to Anaptys pursuant to the Collaboration Agreement continue to be due during the proceedings.

About the Collaboration and Exclusive License Agreement

In March 2014, Anaptys entered into the Collaboration Agreement with Tesaro, an oncology-focused biopharmaceutical company now a part of GSK. Currently, under the Collaboration Agreement, Tesaro is developing Jemperli (dostarlimab) as a monotherapy, and in combination with additional therapies, for various solid tumor indications.

Anaptys is eligible to receive royalties upon sales of Jemperli, equal to 8% of net sales below $1.0 billion, 12% of net sales between $1.0 billion and $1.5 billion, 20% of net sales between $1.5 billion and $2.5 billion and 25% of net sales above $2.5 billion. In Q4 2025, Anaptys anticipates accruing a one-time $75 million commercial sales milestone from Tesaro once Jemperli achieves $1 billion in worldwide net sales.

The royalty term under this collaboration extends at least through expiration of composition of matter coverage on the molecule which expires in 2035 in the U.S. and in 2036 in the EU.

Currently, Jemperli receivables from Tesaro are payable to Sagard as a result of prior capped non-recourse monetizations and will terminate once Sagard has received an aggregate of either $600 million by March 31, 2031, or $675 million any time thereafter. Anaptys estimates Sagard will have accrued $250 million in royalties and sales milestones through year end 2025¹ and anticipates the full paydown of $600 million between Q2 2027 and Q2 2028. 

About Anaptys

Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. The company’s pipeline includes rosnilimab, a pathogenic T cell depleter, which has completed a Phase 2b trial for rheumatoid arthritis; ANB033, a CD122 antagonist, in a Phase 1b trial for celiac disease with plans to expand development into an additional indication; and ANB101, a BDCA2 modulator, in a Phase 1a trial. Anaptys has also discovered and out-licensed in financial collaborations multiple therapeutic antibodies, including a PD-1 antagonist (Jemperli (dostarlimab-gxly)) to GSK and an IL-36R antagonist (imsidolimab) to Vanda Pharmaceuticals. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn.

Anaptys recently announced the intent to separate its biopharma operations from its substantial royalty assets by year-end 2026, enabling investors to align their investment philosophies and portfolio allocation with the strategic opportunities and financial objectives of each company. Learn more here.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the potential termination of the Collaboration Agreement, the timing and potential outcome of proceedings in Delaware Chancery Court, the return of Jemperli to the company, and the nature of the remedies we may obtain in such proceedings. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. 

Contact:
Nick Montemarano
Executive Director, Investor Relations
858.732.0178
investors@anaptysbio.com

^{1. Anticipate ~$250 million of Sagard accruals by YE 2025 including $143 million paid through June 30, 2025, approximately $75 million accrued in the third quarter of 2025 and assumes a ~15% quarter-over-quarter growth rate for Jemperli in Q4 2025}

BioAtla Enters into Agreements for up to $22.5 Million Flexible Financing




BioAtla Enters into Agreements for up to $22.5 Million Flexible Financing

• These agreements are designed to be a flexible financing solution to support operations while finalizing a strategic partnership
• Company is in advanced stages to finalize a strategic transaction with a potential partner, and it remains on track to complete the transaction by year end
• These agreements ensure BioAtla can maintain operational momentum while completing that process

SAN DIEGO, Nov. 21, 2025 (GLOBE NEWSWIRE) — BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that it has entered into Pre-paid Advance Agreements with an affiliate of Yorkville Advisors Global (Yorkville) and funds managed by of Anson Advisors Inc. to provide an aggregate $7.5 million advance to the Company. BioAtla also entered into a Standby Equity Purchase Agreement in which Yorkville has a commitment to buy, if the Company exercises its option, for up to a total of $15 million of common stock at a 3% discount to the then current market prices over three years, subject to certain conditions.

“These agreements provide us with financial flexibility and ensure BioAtla can maintain operational momentum as we work to finalize a strategic partnership that we believe will unlock significant value for BioAtla and our shareholders,” said Jay M. Short, Ph.D., Chairman, CEO and co-founder of BioAtla. “We remain on-track to complete this transaction by year end.”

Key terms of the pre-paid advance include $7.5 million purchased at 95% of face value for $7.125 million gross proceeds received at closing. This advance accrues interest at 4% and may be repaid in cash or converted into common stock based on a conversion price equal to the lower of $1.39 or 95% of the lowest daily VWAP over trading day look back period. The trading day look back period will begin no earlier than November 18, 2025.

Tungsten Advisors acted as the sole placement agent for these agreements.

A more detailed description of the agreements can be found in BioAtla’s Form 8-K filed with the U.S Securities and Exchange Commission (the “SEC”).

Legal Notice
The shares issuable under the Pre-Paid Advance Agreement and the Standby Equity Purchase Agreement are being offered by BioAtla pursuant to an effective shelf registration statement on Form S-3 (File No. 333-269148) previously filed with the SEC on January 6, 2023 and was declared effective on January 17, 2023. A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained from Tungsten Advisors, 767 Third Ave, 29th Floor, New York, NY 10017, by phone at (917) 268-1097 or email at prospectus@tungstenadv.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities offered under either agreement, 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 registration or qualification under the securities laws of any such state or other jurisdiction.

About BioAtla^®, Inc. 
BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary CAB platform technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB platform technology and products with greater than 780 active patent matters, more than 500 of which are issued patents. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. To learn more about BioAtla, Inc., visit www.bioatla.com.

About Ozuriftamab Vedotin (Oz-V)
Ozuriftamab vedotin (Oz-V), CAB-Platform-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a transmembrane receptor tyrosine kinase that is present across many different solid tumors including head and neck, lung, triple-negative breast cancer and melanoma. Overexpression of ROR2, a noncanonical wnt5A signaling receptor, is driven by oncoproteins associated with HPV infection and forms a cancer axis that is associated with poor prognosis and resistance to chemo- and immunotherapies. This Phase 3 ready clinical asset is targeting multiple solid tumor indications, including the treatment of patients with OPSCC who have previously experienced progression on PD-1/L1 therapies and platinum chemotherapy. The FDA granted Fast Track Designation to ozuriftamab vedotin for the treatment of patients with recurrent or metastatic SCCHN.

About CAB-EpCAM x CAB-CD3 Bispecific T-cell Engager Antibody
BioAtla is developing BA3182 as a potential anticancer therapy for patients with advanced adenocarcinoma. BA3182 is a (CAB) EpCAM x (CAB) CD3 bispecific T cell engager antibody that contains two binding sites for EpCAM and two binding sites for CD3ε. The binding sites for EpCAM and CD3ε have been designed to bind their respective targets specifically and reversibly under the conditions found in the TME and to have reduced binding outside of the TME. The CAB selective binding to both the CAB EpCAM and CAB CD3ε arms are required to activate the T cell engagement against the tumor, thus enabling the combined selectivity of each CAB binding arm in the bispecific antibody. BioAtla continues to advance the ongoing Phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of BA3182 in advanced adenocarcinoma patients.

Forward-looking Statements
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words. Examples of forward-looking statements include, among others, statements we make regarding BioAtla’s business plans and prospects; and the expected timing, benefits and outcomes of our strategic partnerships and transactions. Forward-looking statements are based on BioAtla’s current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: factors that raise substantial doubt about our ability to continue as a going concern and that we will need additional funding to continue development of our CAB technology platform and our CAB product candidates; the risk that preliminary or interim clinical results may not be indicative of results from later cohorts or larger populations; potential delays in clinical and preclinical trials; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the successful selection and prioritization of assets to focus development on selected product candidates and indications; our ability to form collaborations and partnerships with third parties and the success of such collaborations and partnerships; our reliance on third parties for the manufacture and supply of our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; potential adverse impacts due to geopolitical or macroeconomic events outside of our control, including health epidemics or pandemics; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 27, 2025, our Quarterly Reports on Form 10-Q filed with the SEC on May 6, 2025, August 7, 2025 and November 13, 2025 and our subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable laws. 

Internal Contact: 
Richard Waldron 
Chief Financial Officer 
BioAtla, Inc. 
rwaldron@bioatla.com
858.356.8945 

External Contact: 
Joyce Allaire
LifeSci Advisors, LLC 
jallaire@lifesciadvisors.com

Inhibikase Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock and Pre-Funded Warrants




Inhibikase Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock and Pre-Funded Warrants

WILMINGTON, Del., Nov. 20, 2025 (GLOBE NEWSWIRE) — Inhibikase Therapeutics, Inc. (NASDAQ: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of pulmonary arterial hypertension (“PAH”), today announced the pricing of its underwritten public offering of 46,091,739 shares of common stock and pre-funded warrants to purchase 22,873,779 shares of common stock. The shares of common stock are being sold at an offering price of $1.45 per share, and the pre-funded warrants are being sold at an offering price of $1.449 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. In addition, Inhibikase has granted the underwriters a 30-day option to purchase up to an additional 10,344,827 shares of its common stock at the public offering price, less underwriting discounts and commissions. The aggregate gross proceeds to Inhibikase from this offering are expected to be approximately $100.0 million, before deducting underwriting discounts and commissions and other offering expenses, excluding the exercise of any pre-funded warrants. All of the securities being sold in the offering are being offered by Inhibikase. The offering is expected to close on November 24, 2025, subject to the satisfaction of customary closing conditions.

Jefferies, BofA Securities and Cantor are acting as joint book-running managers for the offering. LifeSci Capital and Oppenheimer & Co. are acting as co-lead managers for the offering. H.C. Wainwright & Co. and Ladenburg Thalmann & Co. Inc. are acting as co-managers for the offering.

The securities described above are being offered by Inhibikase pursuant to a shelf registration statement on Form S-3 (No. 333-288213) that was previously filed with the Securities and Exchange Commission (“SEC”) and declared effective on June 27, 2025. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.   Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com; BofA Securities, Inc., Attention: Prospectus Department, 201 North Tryon Street, NC1-022-02-25 Charlotte, NC 28255- 0001, or by email at dg.prospectus_requests@bofa.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com.

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

About Inhibikase Therapeutics

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), that arise from aberrant signaling through the Abelson Tyrosine Kinase, and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate, for PAH which is an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “anticipates,” “plans,” or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, uncertainties related to market conditions and statements regarding the timing, size and expected proceeds of the offering, the satisfaction of customary closing conditions related to the offering and sale of securities, and Inhibikase’s ability to complete the offering. These forward-looking statements are based on Inhibikase’s current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase’s actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to execute clinical trials, including to evaluate IKT-001 as a treatment for PAH, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the SEC. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contacts:
Investor Relations:
Michael Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Seren Advanced Dentistry Oxnard Announces Implementation of Biomimetic Conservative Dentistry Led by Dr. Ette Ntekim




Seren Advanced Dentistry Oxnard Announces Implementation of Biomimetic Conservative Dentistry Led by Dr. Ette Ntekim

Oxnard, CA, Nov. 20, 2025 (GLOBE NEWSWIRE) — Seren Advanced Dentistry Oxnard today formally announced the introduction of biomimetic conservative dentistry as part of its restorative care offerings. The announcement marks a structured update to the practice’s clinical direction, led by Dr. Ette Ntekim, who has overseen the implementation of the approach following a series of internal protocol evaluations and training initiatives. This development expands treatment pathways available to individuals seeking a dentist in Oxnard, CA, and reflects the clinic’s continued effort to align with evolving methodologies in contemporary dental care.

Biomimetic conservative dentistry is an evidence-based philosophy focused on preserving natural tooth structure whenever feasible while reconstructing teeth using materials and techniques designed to mimic natural biomechanics. The approach centers on layered adhesive restorations, stress-reduction strategies, and diagnostic assessments aimed at minimizing unnecessary removal of healthy tooth material. With its adoption, Seren Advanced Dentistry Oxnard is making available a practice framework supported by established scientific literature and increasingly recognized across restorative disciplines.

Dr. Ntekim stated that the integration resulted from ongoing evaluation of advancements in minimally invasive dentistry. “Biomimetic conservative dentistry provides a structured method for approaching restorations to maintain as much of the natural tooth as possible,” Dr. Ntekim said. “Our team has dedicated substantial time to training and refining protocols so that the philosophy is applied consistently and responsibly. The intention behind this update is to offer a scientifically grounded treatment option to patients while adhering to standards that support long-term tooth integrity.”

According to the practice, the decision to formally adopt the biomimetic framework followed several months of preparation involving the selection of appropriate materials, the calibration of adhesive workflows, and the implementation of diagnostic procedures that support conservative treatment planning. The clinic noted that the update does not represent a replacement of existing restorative services but rather an additional pathway made available to patients seeking care aligned with conservation-oriented principles.

In explaining the rationale behind the transition, Seren Advanced Dentistry Oxnard highlighted an interest among patients in options that maintain natural tooth structure when possible. Although the clinic emphasized that treatment decisions continue to be guided by clinical assessment rather than preference alone, the inclusion of biomimetic practices allows for an alternative aligned with minimally invasive philosophies when appropriate. The practice clarified that the announcement is intended to inform the public about an expanded methodology rather than imply specific outcomes or advantages.

The adoption of biomimetic conservative dentistry also includes modifications to internal workflows. These changes involve stepwise reinforcement processes, updated adhesive strategies, and criteria-based selection of restorations that follow recognized stages of biomimetic classification. The practice indicated that its team has taken steps to ensure that integration remains consistent with credentialed research and accepted educational practices within the field.

In a statement included with the announcement, practice representative Amin Nassiri commented on the organizational significance of the update. “This initiative reflects our ongoing efforts to align our clinical environment with developments supported by research in restorative dentistry,” Nassiri said. “Introducing biomimetic conservative dentistry required coordinated planning, and our team approached the process with a focus on accuracy, training, and clarity. The announcement is intended to communicate a formal update to the services now available at the practice.”

Seren Advanced Dentistry Oxnard noted that additional information on the biomimetic principles now in use has been made available through the practice’s website, where patients can review general descriptions of the approach and its placement within standard restorative options. The practice further emphasized that biomimetic conservative dentistry is now fully integrated into its active clinical structure and will continue to be evaluated as new research and guidelines emerge.

The clinic reiterated that this announcement is not intended as promotional content but as a corporate update communicating an expansion in treatment methodologies recognized within the field of dentistry. All treatment decisions will continue to be determined through individual clinical evaluation performed by licensed professionals.

Individuals seeking further details may visit the practice’s official website at Dentist in Oxnard | Seren Advanced Dentistry Oxnard.

About Seren Advanced Dentistry Oxnard

Seren Advanced Dentistry in Oxnard is a dental practice offering a range of general and restorative services in Oxnard, CA. The practice maintains a commitment to aligning its care standards with widely accepted research-based methodologies. Additional information can be found on the clinic’s website.

Media Contact
Company Name: Seren Advanced Dentistry Oxnard
Contact Person: Amin Nassiri
Email: amin@dentistnerds.com
Phone: 310-592-6293
Country: United States
Website: https://serendentaloxnard.com/

CONTACT: Media Contact
Company Name: Seren Advanced Dentistry Oxnard
Contact Person: Amin Nassiri
Email: amin@dentistnerds.com
Phone: 310-592-6293
Country: United States
Website: https://serendentaloxnard.com/