Vaxxas Secures TGA Licence to Manufacture Therapeutic Goods




Vaxxas Secures TGA Licence to Manufacture Therapeutic Goods

Milestone enables GMP manufacturing to accelerate clinical trials and transform global vaccine delivery

BRISBANE, Australia and CAMBRIDGE, Mass., Dec. 14, 2025 (GLOBE NEWSWIRE) — Australian biotechnology pioneer Vaxxas Pty Ltd, has been granted a licence by the Therapeutic Goods Administration (TGA) to manufacture the Company’s proprietary high-density microarray patch (HD-MAP) for clinical trials at its state-of-the-art biomedical facility in Brisbane.

This achievement strengthens Vaxxas’ leadership in next-generation vaccine delivery and follows installation of the Company’s first robotic lines for aseptic (sterile) manufacture.

The TGA licence provides Vaxxas with clear competitive advantage placing the Company and its global partners in a strong position to transform vaccine delivery.

Designed to deliver all major vaccine types to the skin using a simple, easy-to-use applicator, the HD-MAP has the potential to be a universal delivery solution for vaccine self-administration.

The manufacturing licence for aseptic (sterile) production includes principles and procedures to ensure the vaccines are of the necessary high quality, as defined by the TGA and Good Manufacturing Practice (GMP) standards.

Vaxxas Chair Sarah Meibusch said, “The TGA manufacturing licence marks a significant milestone for Vaxxas as we progress toward commercialising our HD-MAP technology. By reducing cold-chain requirements and enabling self-administration, this innovation addresses key barriers to vaccine access and uptake worldwide.”

Vaxxas Chief Technology Officer Dr Angus Forster added, “This licence unlocks the way forward for Vaxxas to continue developing our world-leading HD-MAP technology. We are proud to contribute to Queensland’s growing biotech sector and to advance sovereign manufacturing capabilities that translate cutting-edge research to address real-world health solutions.”

About Vaxxas
Vaxxas is a biotechnology company pioneering HD-MAP technology for vaccine delivery. The HD-MAP has been administered to more than 750 participants across early-stage (first-in-human) clinical trials, showing strong safety, tolerability, and robust immune responses. Preclinical and clinical data demonstrate the technology’s ability to deliver all major vaccine types positioning the platform as a potential universal delivery solution. By targeting immune cells just beneath the skin, the HD-MAP has the potential to achieve stronger protection with smaller doses, while reducing cold-chain requirements and enabling self-administration.

Vaxxas has completed six first-in-human clinical trials to date with support from global partners including SK bioscience, the US Government, the Wellcome Trust and Gates foundation to assess the potential of the Company’s HD-MAP technology to vaccinate against COVID-19, seasonal and pre-pandemic influenza, and measles and rubella.

With the potential to disrupt the multibillion-dollar global vaccine market by improving access, reducing costs, and expanding vaccination coverage, Vaxxas is advancing its lead programs toward commercialisation, including the recent installation of the Company’s first robotic lines for aseptic (sterile) manufacture at its state-of-the-art biomedical facility in Brisbane.

About HD-MAP
The Vaxxas high-density microarray patch (HD-MAP) is comprised of thousands of microscopic projections moulded into a small patch. Each microprojection is ‘printed’ with a small dose of vaccine in a dried formulation. When applied to the skin, the patch delivers the vaccine to the abundant immune cells that naturally reside immediately below the skin surface.

HD-MAP vaccine delivery has the potential to overcome challenges faced by traditional needle and syringe delivery of vaccines. The HD-MAP delivery of the vaccine has been shown in early clinical studies to be more stable at higher temperatures than vaccines in liquid formulations, potentially reducing the need for cold-chain storage and distribution. Previous studies have also shown the safety and tolerability of Vaxxas’ HD-MAP for use in vaccine delivery and inducing equal or greater immune responses to injected vaccines at lower doses. HD-MAP vaccines are designed to be self-administered in the future to enable home delivery.

The Vaxxas HD-MAP delivered vaccines are under investigation and available only for investigational uses. They are not available anywhere in the world for sale or purchase. As such, Vaxxas makes no claim that the vaccines are reliable, durable, dependable, safe, or effective, and makes no claim that it is superior to any other vaccine or vaccine delivery technology.

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/50e467aa-d9b5-4794-8ff2-592ad10617e7
https://www.globenewswire.com/NewsRoom/AttachmentNg/6ba1f458-9b0f-4119-834d-00db34fb1b1a

CONTACT: For all media enquiries, please contact:

Amy Miller, We. Communications
+61 431 072 422
amymi@wecommunications.com

InnoCare Announces Achievement of Primary Endpoint in Phase IIb Study of Orelabrutinib for SLE and Approval of Phase III Clinical Trial




InnoCare Announces Achievement of Primary Endpoint in Phase IIb Study of Orelabrutinib for SLE and Approval of Phase III Clinical Trial

BEIJING, Dec. 14, 2025 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the phase IIb clinical study of novel BTK inhibitor orelabrutinib has met the primary endpoint in patients with systemic lupus erythematosus (SLE). InnoCare has also received approval from the Center for Drug Evaluation (CDE) to conduct a phase III registrational clinical trial.

Orelabrutinib demonstrated outstanding efficacy and well-tolerated safety profile in patients with SLE who had received 48 weeks of treatment in the phase IIb study. A total of 187 patients were enrolled and randomized (1:1:1) into three groups: orelabrutinib 75 mg once-daily (QD), orelabrutinib 50 mg QD, and placebo.

The primary endpoint of this study was the SLE Response Index-4 (SRI-4) response rate at week 48. At week 48, the orelabrutinib 75 mg QD group achieved a statistically significant improvement in SRI-4 response rate compared with placebo (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. Additionally, the efficacy of the orelabrutinib 75 mg QD group was better than that of the 50 mg QD group, indicating a dose-dependent improvement trend in efficacy.

At week 48, the orelabrutinib 75 mg QD group demonstrated significantly higher SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates compared to the placebo group (p < 0.05), meeting the secondary endpoint.

In the subgroup of patients with baseline BILAG ≥1A or ≥2B, the placebo-adjusted difference in SRI-4 response rate for orelabrutinib 75 mg QD was 35%. In the subgroup of patients with baseline BILAG ≥1A or ≥2B and a clinical SLEDAI-2K score ≥4, the placebo-adjusted difference in SRI-4 response rate for orelabrutinib 75 mg QD was 43%.

The study showed that orelabrutinib was well tolerated in SLE patients. The safety profile was consistent with the mechanism of action of BTK inhibition and the underlying disease biology of SLE.

Orelabrutinib is the first BTK inhibitor to demonstrate significant efficacy in a phase II clinical trial for SLE. Phase IIa clinical data on orelabrutinib for SLE was previously presented as a late breaking oral presentation at the European Union Congress of Rheumatology (EULAR). Orelabrutinib is expected to become a first-in-class oral BTK inhibitor for the treatment of SLE.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, “SLE patients have huge unmet clinical needs, requiring long-term or even lifelong medication that severely impact their quality of life. We are happy to see that the phase IIb study of orelabrutinib for SLE has met its primary endpoint with outstanding efficacy and has received approval to conduct phase III registrational trial. We will continuously accelerate clinical development to provide better treatment options for patients with SLE and other autoimmune diseases.”

SLE is a systemic autoimmune disease that often leads to damage to multiple organs, particularly the kidneys and musculoskeletal system, nervous system, skin, blood system, and respiratory system; almost all systems can be affected. According to Frost & Sullivan, there are approximately 8 million people with SLE worldwide. According to the “China SLE Development Report 2020”, there are approximately 1 million SLE patients in China, ranking first globally in total number and second in incidence rate. Most SLE patients are young and middle-aged women, requiring long-term management for years or even decades, resulting in huge unmet medical needs.

About InnoCare

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

InnoCare Forward-looking Statements

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

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Milestone Receives FDA Approval of CARDAMYST™ (etripamil) as First and Only Self-Administered Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)




Milestone Receives FDA Approval of CARDAMYST™ (etripamil) as First and Only Self-Administered Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)

• First FDA approved treatment in 30+ years for more than 2 million Americans with PSVT 
• Novel nasal spray designed to rapidly resolve episodes of PSVT and restore sinus rhythm
• FDA approval in PSVT enables development of AFib-RVR under sNDA pathway
• Milestone well-capitalized to launch and commercialize CARDAMYST with existing capital and royalty financing
• Conference call and webcast December 15, 8:00 a.m. ET

MONTREAL and CHARLOTTE, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) — Milestone^® Pharmaceuticals Inc.  (Nasdaq: MIST) today announced that the U.S. Food and Drug Administration (FDA) approved its first commercial product, CARDAMYST™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. This approval marks the first time that more than two million Americans with PSVT will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. CARDAMYST is expected to be available in retail pharmacies in the first quarter of 2026.

CARDAMYST nasal spray is a novel and rapid-acting calcium channel blocker delivered when needed to treat often highly symptomatic and unpredictable episodes of PSVT. With CARDAMYST, adults with PSVT can be prepared wherever and whenever episodes occur, providing them with active management and a greater sense of control of their condition.

“CARDAMYST is a novel at-the-ready treatment option that addresses the unpredictable impact of PSVT by offering patients the freedom to manage episodes anytime and anywhere,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “The FDA approval of CARDAMYST is a watershed moment for Milestone and a gratifying event for our team members, patients, clinical investigators, and health care providers who participated in the development program, all of whom I sincerely thank for their dedication, counsel, and collaboration toward this important achievement.”

“Some people with PSVT have endured years of anxiety, fearing their next episode and the stress and disruption of emergency department visits,” said James Ip, M.D., FACC, FHRS, an etripamil investigator. “CARDAMYST will give many of them the ability to administer a medication themselves that can quickly stop their PSVT episode and potentially avoid a hospital trip or a call to emergency services.”

CARDAMYST Clinical Data

The FDA approval of CARDAMYST is supported by a robust clinical trial program based on safety data from more than 1,800 participants and more than 2,000 episodes of PSVT. This includes the successful Phase 3 RAPID trial, a global, randomized, double-blind comparison of CARDAMYST vs. placebo, published in The Lancet in 2023. In clinical studies, participants using CARDAMYST were two times more likely to convert symptomatic PSVT to sinus rhythm and did so more than three times faster compared with placebo. The RAPID trial achieved its primary endpoint with 64% of those who self-administered CARDAMYST (N=99) converting from supraventricular tachycardia (SVT) to sinus rhythm within 30 minutes compared to 31% on placebo (N=85) (HR = 2.62; p<0.001). At one hour, the benefit was demonstrated in 73% of participants. In addition, significant reductions in time to conversion in those who took CARDAMYST were evident early and durable, with a median time to conversion of 17 minutes (95% CI: 13.4, 26.5) for those treated with CARDAMYST vs. 54 minutes (95% CI: 38.7, 87.3) for those treated with placebo.

A consistent safety profile and treatment effects were observed across all subgroups, including participants concurrently on beta blockers or calcium channel blockers. The most frequent adverse events occurring in ≥5% of participants in randomized clinical trials were mild-to-moderate and transient in nature, including local-site nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis. Less than 2% of trial participants discontinued therapy due to adverse events.

For more safety information about CARDAMYST, please see Important Safety Information below. For the latest information about the product availability, please see https://milestonepharma.com/.

PSVT, also called SVT, is characterized by episodes of abnormally fast heart rate. Most people with PSVT experience multiple sustained episodes that require treatment on an annual basis. Until now, successful treatment options typically required IV administration in healthcare settings, creating stress and costs for patients and their insurers. CARDAMYST offers a new approach to treat episodes of PSVT, enabling adults to self-administer the medication at the onset of symptoms. For more information, please visit SVTHearttoHeart.com.

“Our goal is that CARDAMYST will become a trusted and essential solution for healthcare providers and their patients,” said Lorenz Muller, Chief Commercial Officer of Milestone. “Our team is focused on making CARDAMYST available to adults with PSVT as quickly as possible, including actively working to secure insurance coverage and begin the distribution of the product through retail pharmacies.”

Annette Greene, CARDAMYST clinical trial participant and administrator of the Supraventricular Tachycardia Group on Facebook, with more than 30,000 members, said, “Adults with SVT have been waiting a long time for the day when they can confidently self-administer CARDAMYST to treat their SVT episodes. It is very exciting that the day has become a reality.”

Regarding future R&D, Milestone is poised to enter a Phase 3 program in atrial fibrillation with rapid ventricular rate (AFib-RVR), particularly on the strength of the successful ReVeRA Phase 2 trial in AFib-RVR, results of which were published in Circulation: Arrhythmia and Electrophysiology. Incorporating FDA’s guidance, Milestone has developed a Phase 3 registrational program to evaluate self-administered etripamil as a potential treatment for patients with AFib-RVR. When completed, the Company will be following a supplemental New Drug Application (sNDA) regulatory approval pathway for a potential second indication for etripamil in AFib-RVR. As such, Milestone will leverage the approved PSVT indication and the PSVT program data, along with a single pivotal Phase 3 study in patients with AFib-RVR.

About Paroxysmal Supraventricular Tachycardia

An estimated two million people in the United States are currently diagnosed with PSVT, a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing people with PSVT to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety and negatively impact the day-to-day life between episodes of people with PSVT. The impact and morbidity from an attack can be especially detrimental in people with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options with people with PSVT, often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures.

About Atrial Fibrillation with Rapid Ventricular Rate

An estimated ten million Americans suffer from atrial fibrillation (AFib), a common arrhythmia marked by an irregular, disruptive and often rapid heartbeat. A subset of patients with AFib experience episodes of abnormally high heart rate most often accompanied by palpitations, shortness of breath, dizziness, and weakness. While these episodes, known as AFib-RVR, may be treated by oral calcium channel blockers and/or beta blockers, patients frequently seek acute care in the emergency department to address symptoms. In 2016, nearly 800,000 patients were admitted to the emergency department due to AFib symptoms where treatment includes medically supervised intravenous administration of calcium channel blockers or beta blockers, or electrical cardioversion. With little available data for AFib-RVR, Milestone’s initial market research indicates that 30% to 40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a target addressable market of approximately three to four million patients in 2030 for etripamil in patients with AFib-RVR.

Indication

CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

IMPORTANT SAFETY INFORMATION FOR CARDAMYST (etripamil)

What is CARDAMYST?:

CARDAMYST is a prescription medicine used to help restore normal heart rhythm in adults who have symptoms of sudden episodes of fast heartbeat called paroxysmal supraventricular tachycardia (PSVT).

It is not known if CARDAMYST is safe and effective in children.

Do use CARDAMYST if you:

• are allergic to CARDAMYST or any of its ingredients. See the Patient Information for a complete list of ingredients in CARDAMYST.
• have limitations in activities due to heart failure (moderate to severe heart failure).
• have Wolff-Parkinson-White (WPW) syndrome, Lown-Ganong-Levine syndrome, or an abnormal heart rhythm pattern called pre-excitation (delta wave) on an electrocardiogram (ECG).
• have sick sinus syndrome without a permanent pacemaker.
• have second degree or higher atrioventricular (AV) block.

Before using CARDAMYST, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of fainting.
• have low blood pressure.
• are pregnant or plan to become pregnant. It is not known if CARDAMYST will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if CARDAMYST passes into your breast milk. You should stop breastfeeding for 12 hours after treatment with CARDAMYST. During this time, pump and throw away your breast milk. Talk to your healthcare provider about the best way to feed your baby after using CARDAMYST.

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

What are the possible side effects of CARDAMYST?

CARDAMYST may cause serious side effects, including:

• Fainting due to CARDAMYST effects on blood pressure, heart rate, and electrical activity of the heart. CARDAMYST may cause dizziness and fainting, especially in people with a history of fainting and certain heart problems, or people with a history of fainting during an episode of PVST. Use CARDAMYST while sitting in a safe area where you will not fall if you become dizzy or lightheaded. Lie down if you feel dizzy or lightheaded after using CARDAMYST. If fainting occurs after using CARDAMYST, caregivers should place you on your back and seek medical help.

The most common side effects of CARDAMYST include:

These are not all of the possible side effects for CARDAMYST. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information https://milestonepharma.com/etripamilprescribinginformation.pdf for CARDAMYST.

Milestone Well-Capitalized to Launch and Commercialize CARDAMYST

Milestone is well-capitalized to launch and commercialize CARDAMYST with existing capital and royalty financing. As of September 30, 2025, Milestone had cash, cash equivalents, and short-term investments of $82.6 million. In addition in March 2023, Milestone entered into the Royalty Purchase Agreement with RTW Investments, LP and certain of its affiliates (RTW), pursuant to which RTW agreed to purchase, following the FDA approval (subject to certain conditions) of etripamil on or prior to September 30, 2025 (Approval Date), the right to receive a tiered royalty payments on the annual net product sales of etripamil in the United States, in exchange for a purchase price of $75.0 million. On July 10, 2025, Milestone amended its Royalty Purchase Agreement (the Amendment) to provide for a three-month extension of the Approval Date.

Pursuant to the Amendment, in order to receive the $75.0 million purchase price, Milestone must receive marketing approval of etripamil from the FDA on or prior to December 31, 2025, and satisfy the other customary closing conditions. Milestone anticipates that the FDA approval announced today will satisfy the requirements for Milestone to receive the $75.0 million purchase price.

Conference Call and Live Webcast

Milestone management will host a conference call and live audio webcast with slides at 8:00 a.m. ET on Monday, December 15, 2025, to discuss the FDA approval of CARDAMYST. To access the call, please dial 1-877-407-0792 (domestic) or 1-201-689-8263 (international) and refer to conference ID 13756738, or click on Call me™ link and request a return call. The Call me™ link will be made active 15 minutes prior to scheduled start time. The webcast and slides can be accessed live on this link and also on the “News & Events” page of the Milestone Corporate Website at https://milestonepharma.com/. The archived webcast will also be available on Milestone’s website following the call.

About Milestone Pharmaceuticals

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST™ (etripamil) nasal spray, a novel calcium channel blocker, which is FDA approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in development for the treatment of symptomatic episodic attacks associated with AFib-RVR.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will”, “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: expectations on the timing of CARDAMYST for PSVT being available to patients in retail pharmacies; CARDAMYST’s potential as a novel treatment option to help patients with PSVT; Milestone’s ability to make CARDAMYST quickly available to PSVT patients following FDA approval; the success of Milestone’s launch infrastructure; the timing of patient enrollment in the Phase 3 study of etripamil for AFib-RVR and expectations regarding the Phase 3 study in patients with AFib-RVR; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended September 30, 2025, in each case under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact: 

Investor Relations 
Kevin Gardner, kgardner@lifesciadvisors.com 

Media Relations 
Rebecca Novak, rnovak@milestonepharma.com  

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1cd3bcec-2019-4e39-b90e-aab21bcd97ac.

Accelerating Patient Recruitment and Research Excellence: TrialWire® Supports Endpoints Clinical Trials Day NYC 2025




Accelerating Patient Recruitment and Research Excellence: TrialWire® Supports Endpoints Clinical Trials Day NYC 2025

NEW YORK, Dec. 12, 2025 (GLOBE NEWSWIRE) — TrialWire^®, the industry’s fastest, intelligent patient recruitment engine breaking the bottleneck in clinical development, proudly supported Endpoints News’ 2025 Clinical Trials Day in New York City. The event gathered leaders from across the biopharma ecosystem to discuss the evolution of clinical research and how technology continues to improve patient access and study efficiency.

“Getting a new drug through the clinical trials gauntlet is more complex than ever. Costs are higher, competition is intense, and despite the innovation of the past decades, timelines are still long and success rates are low,” said Endpoints.

Watch videos from the day here

Topics include: Why clinical trials stay costly in the US – and cheap in China

The global clinical trial technology market is projected to reach USD 22.7 billion by 2030, expanding at a compound annual growth rate (CAGR) of 8.3%. Within this, AI-enabled patient recruitment solutions are expected to play a major role as sponsors seek faster enrollment, increased trial diversity, and improved retention outcomes.

“As the pace of innovation accelerates, biotechs must future-proof their development strategies,” said Susan Fitzpatrick-Napier, CEO TrialWire. “Patient recruitment technologies are more than a rescue function. By embedding an AI-powered engine like TrialWire at the beginning of the trial, sponsors can avoid costly delays and bring life-changing treatments to patients faster. TrialWire’s success-based fee model further supports operational cost control.”

TrialWire’s intelligent technology-driven approach aligns with growing industry recognition that AI and digital innovation will transform clinical development. By integrating recruitment intelligence technology early, sponsors and CROs improve readiness, optimize timelines, ensure their programs are resilient in increasingly complex regulatory and competitive environments, and reduce operational cost.

Endpoints’ Clinical Trials Day has become a pivotal event recognizing progress, collaboration, and innovation in global clinical research—highlighting the importance of companies like TrialWire in shaping the next generation of trial efficiency and patient engagement.

About TrialWire^®
TrialWire, the industry’s fastest, intelligent patient recruitment engine, can activate within 24 hours. TrialWire’s solutions including RapidStart™ and RapidRescue™ accelerate enrollment through our award-winning platform to quickly reach, engage and pre-screen participants to meet development timelines. All on a success-based fee model. Designed for biotech and trial sites TrialWire has a track record in accelerating study timelines. Powered by Salesforce Health Cloud and fully HIPAA & GDPR compliant, our system ensures world-class security and data integrity. With locations in San Francisco, New York, Sydney, Singapore and Paris TrialWire operates globally to deliver rapid recruitment continuity for every client. For more information, visit www.trialwire.com.

CONTACT: Media Contact

team@trial-wire.com

Genesis Healthcare Remains Committed to Securing Longterm Stability




Genesis Healthcare Remains Committed to Securing Longterm Stability

The skilled nursing, assisted and senior living provider reiterates dedication to a financial restructuring process centered around current and future patients, residents and staff

KENNETT SQUARE, Pa., Dec. 12, 2025 (GLOBE NEWSWIRE) — Following a court ruling on Thurs., Dec. 11 to reopen the auction process in Genesis Healthcare, Inc.’s (Genesis) and its affiliates’ ongoing chapter 11 bankruptcy proceedings, David Harrington, Executive Chairman of the Board of Genesis, reiterated the company’s commitment to securing long-term stability through the court-supervised chapter 11 proceedings, clarified inaccuracies in public conversations surrounding the process, and called on all interested parties to recognize – and respect – the hard work and dedication of the Genesis employees who are continuing to deliver services to the elderly and frail residents and patients that they serve during this protracted restructuring process.

“Genesis has significantly strengthened our operational performance, especially in the past two years, by investing in, designing and implementing a forward-looking, enterprise-wide shift from centralized to local market-based operations,” said Harrington. “The Genesis board, in alignment with the company’s executive leadership team – which has been completely transformed in the past three years – identified the Chapter 11 process as the necessary path to maintain and grow that momentum for years to come to benefit our current and future patients, residents and staff. That belief has not changed.”

As has been widely covered by the media, this is not the first time Genesis has considered bankruptcy proceedings. In 2021, Genesis was actively preparing to file for Chapter 11 bankruptcy. Some of the notable voices weighing in on this week’s proceedings were heavily – and vocally – opposed to a filing in 2021, which was ultimately avoided due to ReGen Healthcare’s $100 million investment into Genesis.

“Much has been made – and alleged – about Joel Landau’s association with Genesis, which did not begin until ReGen’s investment in 2021, which enabled Genesis to avert bankruptcy, as many in the public realm were demanding,” said Harrington. “Prior to 2021, ReGen Healthcare (ReGen) and Mr. Landau had no affiliation with or control over Genesis. The investment by ReGen provided Genesis with a lifeline to try to restructure the company outside of bankruptcy and enabled Genesis to completely revamp its executive leadership team, beginning its ongoing transformation to a nimble, market-based model dedicated to prioritizing resident and patient care.”

Some interested parties have called attention to decisions made by Genesis Healthcare to transfer its owned skilled nursing facilities to Welltower, Inc. in 2011 – fully 10 years prior to ReGen’s investment or Mr. Landau’s affiliation with Genesis (which began in 2021) – and simultaneously to enter into a master lease with Welltower, allowing Genesis to continue operating those facilities.

“I hope everyone will understand that none of the current officers or Board members that were with Genesis in 2011, when the decision was made to transfer real estate ownership to Welltower are still with Genesis today,” said Harrington.

Genesis shares interested parties’ focus on patients, residents and staff, and the importance of safeguarding access to high-quality post-acute care in the communities served by the more than 170 skilled nursing centers and assisted and senior living communities across 17 states operated by Genesis.

“I am proud of how, despite the potential for distraction during this restructuring process, our staff continues to put our mission into action by improving the lives we touch through the delivery of high-quality healthcare and everyday compassion,” said Harrington. “Decisions being made by the bankruptcy court regarding the ultimate purchaser of Genesis do not have anything to do with our commitment to our day-to-day operations, and I hope people will remember that as they continue to weigh in on this process. We are confident that entering into chapter 11 and engaging in fulsome restructuring efforts was and still is in the best interest of our current and future patients, residents and staff, and we take issue with those questioning the integrity of our frontline team members who have dedicated themselves to helping others.”

An independent third party engaged by Genesis to conduct patient satisfaction surveys in 2025 has reported:

• 91% favorable rating for relationship with staff members
• 89% favorable rating for leadership taking important measures to keep them safe
• 87% favorable rating for the amount of interaction with staff

Additionally, Genesis has reduced its overall employee turnover year-over-year by 6%, and is maintaining an overall Google rating of 4.3 out of 5 stars for all Genesis Healthcare, Inc.

Genesis would welcome local, state and federal legislative parties interested in learning more about the care provided at our facilities to contact us to schedule a tour.

Court filings and additional information related to the proceedings, which include a proposed transaction involving a current affiliate, are available at https://dm.epiq11.com/Genesis. Those with questions can call (toll-free in the US) 888-861-3979.

Advisors
McDermott Will & Schulte LLP is serving as legal counsel, Ankura Consulting is providing financial restructuring and Chief Restructuring Officer services (Russell A. Perry and Louis E. Robichaux IV, Co-CROs), and Jefferies is serving as investment banker.

ABOUT GENESIS HEALTHCARE, INC.
Genesis Healthcare, Inc. is a holding company with affiliates that operate skilled nursing facilities and assisted/senior living communities. Its subsidiaries also specialize in contract rehabilitation therapy, respiratory therapy, physician services, and accountable care, collectively referred to as Genesis HealthCare. To learn more, visit www.genesishcc.com.

CONTACT: MEDIA CONTACT
mediainquiry@genesishcc.com

Extendicare Announces December 2025 Dividend of C$0.042 per Share




Extendicare Announces December 2025 Dividend of C$0.042 per Share

MARKHAM, Ontario, Dec. 12, 2025 (GLOBE NEWSWIRE) — Extendicare Inc. (“Extendicare” or the “Company”) (TSX: EXE) announced that it has declared a cash dividend of C$0.042 per common share of the Company for the month of December 2025, which is payable on January 15, 2026 to shareholders of record at the close of business on December 31, 2025. This dividend is designated as an “eligible dividend” within the meaning of the Income Tax Act (Canada).

About Extendicare

Extendicare is a leading provider of care and services for seniors across Canada, operating under the Extendicare, ParaMed, Extendicare Assist, and SGP Purchasing Network brands. We are committed to delivering quality care to meet the needs of the growing seniors’ population, inspired by our mission to provide people with the care they need, wherever they call home. We operate a network of 99 long-term care homes (59 owned, 40 under management contracts), deliver approximately 13.5 million hours of home health care services annually, and provide group purchasing services to third parties representing approximately 152,100 beds across Canada. Extendicare proudly employs approximately 28,000 qualified, highly trained and dedicated team members who are passionate about providing high-quality care and services to help people live better.

Forward-looking Statements

Information provided by Extendicare from time to time, including this release, contains or may contain forward-looking statements concerning anticipated future events, results, circumstances, economic performance or expectations with respect to Extendicare and its subsidiaries, including, without limitation: statements regarding its dividend levels, business operations, business strategy, growth strategy, results of operations and financial condition. Forward-looking statements can often be identified by the expressions “anticipate”, “believe”, “estimate”, “expect”, “intend”, “objective”, “plan”, “project”, “will”, “may”, “should” or other similar expressions or the negative thereof. These forward-looking statements reflect the Company’s current expectations regarding future results, performance or achievements and are based upon information currently available to the Company and on assumptions that the Company believes are reasonable. These statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of the Company to differ materially from those expressed or implied in the statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on Extendicare’s forward-looking statements. Further information can be found in the disclosure documents filed by Extendicare with the securities regulatory authorities, available at www.sedarplus.ca and on Extendicare’s website at www.extendicare.com. Except as required by applicable securities laws, the Company assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Extendicare contact:

Jillian E. Fountain

Vice President, Investor Relations
T: (905) 470-5534
E: jfountain@extendicare.com
www.extendicare.com

Teva to Host Conference Call to Discuss Fourth Quarter 2025 Financial Results at 8 a.m. ET on January 28, 2026




Teva to Host Conference Call to Discuss Fourth Quarter 2025 Financial Results at 8 a.m. ET on January 28, 2026

TEL AVIV, Israel, Dec. 12, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will issue a press release on its fourth quarter 2025 financial results on Wednesday, January 28, 2026, at 7:00 a.m. ET. Following the release, Teva will conduct a conference call and live webcast on the same day, at 8:00 a.m. ET.

In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin.

A live webcast of the call will be available on Teva’s website at: https://ir.tevapharm.com/Events-and-Presentations.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva’s website.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This Document and the presentation at the conferences may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Teva Media Inquiries
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries
TevaIR@Tevapharm.com

Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease




Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease

NEW YORK, Dec. 12, 2025 (GLOBE NEWSWIRE) — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer’s disease, Parkinson’s disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today provides an update on the regulatory review in the EU for blarcamesine to treat early Alzheimer’s disease.

As per previous communication, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had informed Anavex about a negative trend-vote following its oral examination in November. As expected, the CHMP has adopted a negative opinion on the marketing authorisation application for blarcamesine to treat Alzheimer’s disease. The Company intends to request a re-examination of the CHMP opinion. The EMA procedures adopted by the CHMP allow an applicant to request re-examination of its decision, which would be undertaken by a different set of reviewers that conduct a new examination, independent from the first opinion.

We believe that the initiated dialogue reinforced our shared commitment to addressing the urgent unmet need in Alzheimer’s disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Our team is committed to continue working in partnership with regulatory bodies in order to advance science and potentially new oral treatment options for patients and their families.”

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

About Alzheimer’s disease

Alzheimer’s disease is the most common cause of dementia, accounting for 60-80% of all dementia cases worldwide. Dementia is a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer’s disease is a progressive disease, where symptoms gradually worsen over time. Each stage of the disease presents different challenges for those living with the disease and their care partners. There is a significant unmet need for new treatment options that can slow down the progression of Alzheimer’s disease and reduce the overall burden on people affected and on society.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com

Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com

GRI Bio Announces Closing of $8.0 Million Public Offering




GRI Bio Announces Closing of $8.0 Million Public Offering

LA JOLLA, CA, Dec. 12, 2025 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the closing of its previously announced public offering of an aggregate of 10,666,667 shares of its common stock (or common stock equivalents in lieu thereof), Series F warrants to purchase up to 10,666,667 shares of common stock (the “Series F Warrants”), at a combined public offering price of $0.75 per share (or per common stock equivalent in lieu thereof) and accompanying Series F Warrant. The Series F Warrants have an exercise price of $0.75 per share and are exercisable immediately upon issuance and will expire on the fifth anniversary of the initial issuance date.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering were approximately $8.0 million before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the Series F Warrants, if fully exercised on a cash basis, will be approximately $8.0 million. No assurance can be given that any of the Series Warrants will be exercised. The Company intends to use the net proceeds from this offering for its product candidate development, working capital and general corporate purposes.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-291999), as amended, which was declared effective by the Securities and Exchange Commission (the “SEC”) on December 11, 2025. The offering was made only by means of a prospectus forming part of the effective registration statement relating to the offering. Electronic copies of the final prospectus may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

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

About GRI Bio, Inc.

GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of NKT cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 diverse NKT agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline.

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. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the anticipated use of proceeds from the offering; the exercise of the Series F Warrants prior to their expiration; the Company’s ability to maintain compliance with the Nasdaq listing requirements; the Company’s expectations with respect to development and commercialization of the Company’s product candidates; the timing of initiation or completion of clinical trials and availability of resulting data, the potential benefits and impact of the Company’s clinical trials and product candidates and any implication that the data or results observed in preclinical trials or earlier studies or trials will be indicative of results of later studies or clinical trials. Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) market and other conditions; (2) the inability to maintain the listing of the Company’s common stock on Nasdaq and to comply with applicable listing requirements; (3) changes in applicable laws or regulations; (4) the inability of the Company to raise financing in the future; (5) the success, cost and timing of the Company’s product development activities; (6) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (7) the inability of the Company to identify, in-license or acquire additional technology; (8) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (9) the size and growth potential of the markets for the Company’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (10) the failure to achieve any milestones or receive any milestone payments under any agreements; (11) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (12) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (13) other risks and uncertainties indicated from time to time in the Company’s filings with the SEC, including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 14, 2025 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
GRI@jtcir.com

CAMP4 Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




CAMP4 Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

CAMBRIDGE, Mass., Dec. 12, 2025 (GLOBE NEWSWIRE) — CAMP4 Therapeutics Corporation (“CAMP4” or “the Company”) (Nasdaq: CAMP), a clinical-stage biopharmaceutical company developing a pipeline of regulatory RNA-targeting therapeutics designed to upregulate gene expression with the goal of restoring healthy protein levels to treat a broad range of genetic diseases, today announced that on December 11, 2025 (the “Grant Date”), the Company’s Board of Directors granted non-qualified stock options to purchase an aggregate of 92,000 shares of the Company’s common stock to four newly hired employees of the Company, each as an inducement material to each employee’s entry into employment with the Company, in accordance with Nasdaq Listing Rule 5635(c)(4) (the “Inducement Grants”).

The Inducement Grants each have a ten-year term and an exercise price per share of $6.01, which is equal to the closing price of CAMP4’s common stock on the Grant Date. The Inducement Grants will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of the employee’s first day of employment with the Company, and thereafter the remainder of the option will vest in 36 equal monthly installments, subject to the employee’s continued service with CAMP4 through the applicable vesting dates. Each Inducement Grant was granted pursuant to, and is subject to, the terms and conditions of an Inducement Option Award Agreement.

About CAMP4 Therapeutics 
CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (regRNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAP Platform® enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. For more information, visit camp4tx.com. 

Contacts

Investor Relations:
Sara Michelmore
Milestone Advisors
sara@milestone-advisorsllc.com

Media:
Jason Braco, Ph.D.
LifeSci Communications
jbraco@lifescicomms.com