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Rapport Therapeutics to Participate in Upcoming Investor Conferences

BOSTON and SAN DIEGO, Feb. 24, 2025 (GLOBE NEWSWIRE) — Rapport Therapeutics, Inc. (Nasdaq: RAPP), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients suffering from central nervous system (CNS) disorders, today announced that management will present at two upcoming investor conferences in March 2025.

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Annual Health Care Conference (Boston) – fireside chat on Tuesday, March 4, 2025, at 3:10-3:40pm EST.

Stifel 2025 Virtual CNS Forum – fireside chat on Wednesday, March 19, 2025, at 10:30-10:55am EST.

Interested parties may access the live and archived webcasts under the “Investors” section of the company’s website at: https://investors.rapportrx.com.

About Rapport Therapeutics

Rapport Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing small molecule precision medicines for patients suffering from central nervous system (CNS) disorders. The Company’s founders have made pioneering discoveries related to the function of receptor associated proteins (RAPs) in the brain. Their findings form the basis of Rapport’s RAP technology platform, which enables a differentiated approach to generate precision small molecule product candidates with the potential to overcome many limitations of conventional neurology drug discovery. Rapport’s precision neuroscience pipeline includes the Company’s lead clinical program, RAP-219, designed to achieve neuroanatomical specificity through its selective targeting of a RAP expressed in only discrete regions of the brain. The Company is currently advancing RAP-219 in clinical trials in focal epilepsy, diabetic peripheral neuropathic pain, and bipolar mania. Additional preclinical and late-stage discovery stage programs are also underway, targeting CNS disorders including chronic pain and hearing disorders.



Contact
Julie DiCarlo
Head of Communications & IR
Rapport Therapeutics
[email protected]

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Capital City Bank Establishes Chief Banking Officer; Names New Chief Lending Officer

Newly Created Chief Banking Officer Leadership Role Aims To Support Strategic Growth and Cohesion Across Lending and Deposit Functions

TALLAHASSEE, Fla., Feb. 24, 2025 (GLOBE NEWSWIRE) — Capital City Bank announces a newly created executive role of chief banking officer, providing comprehensive oversight of the lending and deposit functions of the Bank with a strategic focus on growth, efficiency and operational cohesion. The position has been filled by Ramsay Sims, a tenured member of the Company’s senior leadership team who brings broad expertise in financial services and effective leadership. Concurrently, William Smith has been promoted to chief lending officer, filling the vacancy left by Sims’ promotion to chief banking officer.

“Adding this new leadership role positions us for long-term success and sustained excellence as we continue to grow,” said Bill Smith, Capital City Bank Group Chairman, President and CEO. “With Ramsay’s extensive experience, proven track record and demonstrated ability to lead in diverse banking environments, he is well-equipped to drive the strategic goals and objectives of this critical role.”

As chief banking officer providing high-level oversight of both lending and deposit functions of the Bank, Sims will streamline the strategic direction of these areas, allowing for more efficient management and alignment of growth objectives. Smith will focus on driving the lending strategies of the Bank as chief lending officer under Sims’ direction.

Capital City Bank Group Chairman, President and CEO Bill Smith added, “Ramsay has been a key contributor to our success since he joined the Bank. I have consistently valued his expertise as a member of our executive leadership team. Likewise, William’s diverse background, impressive achievements and deep understanding of the market will add additional strength to our executive ranks. I am confident that these enhancements to our executive management team will provide a solid foundation for continued progress and future growth.”

Sims came to Capital City Bank in 2010 and served most recently as chief lending officer. He has amassed decades of experience serving corporations, governments and non-profit organizations in the financial sector. Before joining Capital City Bank, Sims spent five years in public finance with Merrill Lynch, three years in corporate tax-exempt finance with Banc of America Securities and six years with GE Capital. He holds a bachelor’s degree in economics from the University of the South (Sewanee) and a master’s in business administration from Florida State University.

Smith, who served most recently as North Florida Region executive overseeing an operational area that included Leon, Gadsden, Jefferson, Madison, Taylor and Wakulla counties in Florida and Grady County in Georgia, joined Capital City Bank in 2007 as a management trainee. Over his career, Smith has gained expertise in multiple specialties, including small business, commercial real estate, special assets and private banking. In 2020, he was appointed the market president overseeing Leon County and served three years in that role until being promoted to North Florida Region executive in 2023. Smith demonstrates a deep commitment to community advocacy through service on multiple non-profit boards, including Big Bend Hospice, where he holds the office of treasurer, and the Tallahassee Chamber of Commerce. He is also a member of the Tallahassee Entrepreneurs Organization and Florida Bankers Association Government Relations Council.

About Capital City Bank Group, Inc.

Capital City Bank Group, Inc. (NASDAQ: CCBG) is one of the largest publicly traded financial holding companies headquartered in Florida and has approximately $4.3 billion in assets. We provide a full range of banking services, including traditional deposit and credit services, mortgage banking, asset management, trust, merchant services, bankcards, securities brokerage services and financial advisory services, including the sale of life insurance, risk management and asset protection services. Our bank subsidiary, Capital City Bank, was founded in 1895 and now has 63 banking offices and 104 ATMs/ITMs in Florida, Georgia and Alabama. For more information about Capital City Bank Group, Inc., www.ccbg.com.

For Information Contact:

Brooke Hallock
[email protected]
850.402.8525

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/8d7d86ca-9eaa-4b27-a720-ce03ed405f6f

https://www.globenewswire.com/NewsRoom/AttachmentNg/93aea2c1-c40c-48d0-ba61-febe3f386283



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Axsome Therapeutics Announces SYMBRAVO® (meloxicam and rizatriptan) Achieves Primary Endpoint in the EMERGE Phase 3 Trial in Migraine Patients Experiencing Inadequate Response to Oral CGRP Inhibitors

SYMBRAVO demonstrated statistically significantly greater migraine treatment response compared to prior treatment with an oral CGRP inhibitor (p<0.001, mTOQ-4 total score, primary endpoint)

2-hour pain freedom for most attacks reported at least half the time by 47.9% of patients after SYMBRAVO versus 1.0% after oral CGRPs (p<0.001)

24-hour or greater sustained pain relief after a single dose reported by 47.9% of patients after SYMBRAVO versus 16.7% after oral CGRPs (p<0.001)

Ability to quickly return to normal activities reported by 51.0% of patients after SYMBRAVO versus 11.5% after oral CGRPs (p<0.001)

SYMBRAVO improved quality of life compared to after oral CGRPs (p<0.001, MSQ)

NEW YORK, Feb. 24, 2025 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the EMERGE Phase 3 trial of SYMBRAVO® (MoSEIC™ meloxicam and rizatriptan) in patients experiencing inadequate response to oral CGRP inhibitors met its primary endpoint, with SYMBRAVO demonstrating statistically significantly greater migraine treatment response compared to oral CGRP inhibitors, as measured by the Migraine Treatment Optimization Questionnaire (mTOQ-4). SYMBRAVO is a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack. In the trial, SYMBRAVO rapidly and substantially improved migraine pain and most bothersome symptoms.

EMERGE was an open-label trial that enrolled migraine patients who were undergoing treatment with an oral CGRP inhibitor for at least one month and experiencing an inadequate response to the oral CGRP inhibitor, with treatment response assessed using the mTOQ-4. Enrolled patients were switched to treatment with SYMBRAVO for their next four attacks. Treatment responses after the oral CGRP inhibitor treatment period and after the SYMBRAVO treatment period were compared. A total of 96 patients were enrolled and 365 migraine attacks were treated with SYMBRAVO in the trial.

EMERGE met the primary endpoint by demonstrating statistically significantly greater migraine treatment response with SYMBRAVO compared to treatment response with prior oral CGRP inhibitors, as assessed by the mTOQ-4 total score (5.2 versus 2.8, p<0.001). Statistically significantly greater proportions of patients achieved clinical response on the 2-hour pain freedom, sustained pain freedom, ability to return to normal activities, and ability to plan daily activities mTOQ-4 items with SYMBRAVO compared to oral CGRP inhibitors:

  • Pain freedom within 2 hours for most attacks was reported half the time or more by 47.9% of patients after treatment with SYMBRAVO, compared to 1.0% of patients after treatment with oral CGRPs (p<0.001).
  • Sustained relief of migraine pain for at least 24 hours following a single dose of medication was reported half the time or more by 47.9% of patients after treatment with SYMBRAVO, compared to 16.7% of patients after treatment with oral CGRPs (p<0.001).
  • The ability to quickly return to normal activities after taking their medication was reported half the time or more by 51.0% of patients after treatment with SYMBRAVO, compared to 11.5% of patients after treatment with oral CGRPs (p<0.001).
  • The proportion of patients who reported being comfortable enough with their medication to be able to plan daily activities half the time or more was 63.5% after treatment with SYMBRAVO, compared to 26.0% after treatment with oral CGRPs (p<0.001).

Further, SYMBRAVO treatment resulted in a statistically significant improvement in overall quality of life and daily functioning, as assessed by all three domains of the Migraine-Specific Quality of Life Questionnaire (MSQ), compared to after treatment with oral CGRP inhibitors (p=0.003 to <0.001).

Richard B. Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center, Albert Einstein College of Medicine, commented, “The results of the EMERGE study demonstrate significant improvements in migraine treatment response with SYMBRAVO for patients previously experiencing inadequate response to oral CGRPs based on the mTOQ-4. Migraine is a disabling neurological condition, and the multiple mechanisms of action of SYMBRAVO may be relevant to the complex and heterogenous nature of this serious condition. These data from the EMERGE study are compelling and provide further evidence for the utility of SYMBRAVO across a variety of migraine settings.”

In this population of patients with a prior inadequate response to an oral CGRP inhibitor, SYMBRAVO rapidly and substantially relieved migraine pain within 2 hours, with benefits sustained through 24 and 48 hours after a single dose. Across all treated attacks, pain relief 2 hours after dosing with SYMBRAVO was achieved by 50.0% of patients, with some patients experiencing pain relief as early as 30 minutes after dosing. The pain relief achieved 2 hours after dosing was sustained through 24 and 48 hours by 78% and 75% of patients respectively. Pain freedom and freedom from the most bothersome symptom 2 hours after dosing with SYMBRAVO was achieved by 22.5% and 26.6% of patients, respectively.

Overall improvement of migraine, measured using the Patient Global Impression of Change (PGI-C), was experienced early and in a substantial proportion of patients after treatment with SYMBRAVO. Overall improvement of their migraine was reported by 26.0% of patients 30 minutes post dose, and by 69.2% of patients 2 hours post dose.

SYMBRAVO was well tolerated with a safety profile that was consistent with what has been previously observed in prior studies. The most commonly reported adverse events (≥2%) were fatigue (3.1%), nausea (3.1%), vomiting (2.1%), muscle tightness (2.1%), and dizziness (2.1%).

Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics, said, “We’re pleased to share the results of the Phase 3 EMERGE trial, which further underscore the robust efficacy of SYMBRAVO and its potential to effectively treat migraine attacks across a range of patient populations with varying pain intensities and prior responses to acute treatments. We look forward to launching SYMBRAVO in the U.S. in the coming months and offering a new treatment option that could make a meaningful difference for patients suffering from this disabling condition.”

About the EMERGE Trial

EMERGE (Evaluating Outcomes of AXS-07 after Acute Gepant Failures) was a Phase 3, open-label, multicenter trial to evaluate the efficacy and safety of SYMBRAVO in the acute treatment of migraine in patients experiencing inadequate response to an oral calcitonin gene-related peptide (CGRP) inhibitor. Eligible patients must have been using an oral CGRP inhibitor for the acute treatment of migraine for at least 1 month prior to enrollment (having treated at least 4 migraines with an oral CGRP inhibitor) and have had an inadequate response to the oral CGRP inhibitor. An inadequate response was defined as a score of ≤7 on the Migraine Treatment Optimization Questionnaire (mTOQ-4), including a score of 1 (“less than half the time”) or 0 (“rarely” or “never”) on Question 2 (achievement of pain freedom 2 hours after taking migraine medication). Enrolled patients were switched from their oral CGRP inhibitor to SYMBRAVO and treated the next 4 migraine attacks with SYMBRAVO over a period of up to 8 weeks. A total of 96 patients were enrolled in the trial. The primary efficacy endpoint to assess treatment response with SYMBRAVO versus oral CGRP inhibitors was the change in the mTOQ-4 total score from the oral CGRP inhibitor treatment period to the SYMBRAVO treatment period.

About the Migraine Treatment Optimization Questionnaire (mTOQ-4)

The mTOQ-4 is a validated questionnaire that assesses the adequacy of migraine treatment efficacy based on four aspects of response to acute treatment: 2-hour pain freedom; sustained pain freedom; ability to quickly return to daily activities; and comfort planning daily activities. Each of the 4 items is scored, using frequency-based options, as never [0], rarely [0], less than half the time [1], and half of the time or more [2]. Total scores range from 0 to 8 with higher total scores corresponding to greater treatment optimization. A total score of 8 corresponds to maximum treatment efficacy, with total scores of 4-7 corresponding to moderate, 1-3 to poor, and 0 to very poor treatment optimization.1

About Migraine

Migraine is a serious neurological condition characterized by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea, sensitivity to light, and sensitivity to sound.2 It is estimated that over 39 million Americans suffer from migraine, and it is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation.3-5 Extensive surveys of migraine sufferers underscore the unmet need for therapies that work faster, more consistently, and result in less symptom recurrence.6,7 Over 70% of patients report experiencing an inadequate response to their oral, acute migraine treatment.8

About SYMBRAVO

SYMBRAVO is a novel, oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults. SYMBRAVO consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which enables the rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT1B/1D agonist. SYMBRAVO is designed to provide rapid, enhanced, and consistent migraine pain relief, and reduced symptom recurrence. The exact mechanism of action of SYMBRAVO in the treatment of acute migraine is unknown.

For more information, visit www.symbravo.com.

What is SYMBRAVO (sim-BRAH-voh)? SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a triptan). SYMBRAVO is an oral prescription medicine used to treat acute migraine headaches with or without aura in adults.

SYMBRAVO is not used to prevent or decrease the number of migraine headaches you have or for treatment of hemiplegic or basilar migraines. SYMBRAVO is not indicated as a treatment for cluster headaches or for use in children.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMBRAVO?

SYMBRAVO may increase the risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase with increasing doses, and longer use, of NSAIDs.

Do not take SYMBRAVO right before or after a heart surgery called a “coronary artery bypass graft” (CABG).

Avoid taking SYMBRAVO after a recent heart attack unless your healthcare provider (HCP) tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

Stop taking SYMBRAVO and get emergency help right away if you have any of the following symptoms which can be indicative of a heart attack or stroke:

  • discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or one side of your body
  • slurred speech

People with risk factors for heart disease should not take SYMBRAVO unless a heart exam is done and shows no problem. You have higher risk for heart disease if you:

  • have high blood pressure
  • have high cholesterol
  • smoke
  • are overweight
  • have diabetes or a family history of diabetes

SYMBRAVO can increase the risk of potentially life-threatening bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines that can occur anytime during use and without warning symptoms.

SYMBRAVO may cause serious allergic or skin reactions which can be life-threatening. Stop taking SYMBRAVO and get emergency help right away if you develop:

  • sudden wheezing or problems breathing or swallowing
  • rash or reddening of your skin with blisters or peeling
  • blisters or bleeding of your lips, eye lids, mouth, nose, or genitals
  • swelling of your lips, tongue, throat or body
  • fainting

SYMBRAVO already contains an NSAID (meloxicam). Do not use SYMBRAVO with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your HCP first, because they may contain an NSAID also.

Do not take SYMBRAVO if you:

  • have or had heart problems or right before or after heart bypass surgery
  • have or had a stroke or transient ischemic attack (TIA)
  • have or had blood vessel problems of your legs and arms, stomach (ischemic bowel disease), or kidneys
  • have or had hemiplegic or basilar migraines
  • have uncontrolled high blood pressure
  • take propranolol containing medicines
  • have taken other triptan or ergot-containing medicines within the last 24 hours
  • take an antidepressant medicine called monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the last 2 weeks
  • are allergic to meloxicam, rizatriptan, NSAIDs, or any of the ingredients in SYMBRAVO
  • have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs
  • have moderate to severe kidney problems and are at risk of kidney failure or if you are on dialysis

SYMBRAVO may cause serious side effects. These serious side effects include:

  • heartbeats that are too fast or too slow (arrhythmias)
  • new or worse high blood pressure
  • heart failure
  • life-threatening skin reactions
  • liver or kidney problems including organ failure
  • low red blood cell count (anemia)
  • asthma attacks in people who have asthma

Medication Overuse Headaches: Some people who use too many SYMBRAVO tablets may have worse headaches. If your headaches get worse, your HCP may decide to stop your treatment with SYMBRAVO.

Stop taking SYMBRAVO and get emergency help right away if you have any of the following:

  • Stomach and intestinal problems. Symptoms of gastrointestinal and colonic ischemic events may include sudden or severe stomach pains even after meals; sudden weight loss; severe nausea, vomiting, constipation, diarrhea; and bloody diarrhea.
  • Circulation problems to legs and feet. Symptoms of peripheral vascular ischemia may include cramping and pain in your legs and hips; heaviness or tightness in leg muscles; burning, aching, numbness, tingling, or weakness in your legs, feet, or toes; cold feelings or color changes in one or both legs or feet.
  • Serotonin syndrome. Can happen when taking SYMBRAVO with antidepressant medicines called SSRIs or SNRIs. Stop taking SYMBRAVO and call your doctor right away if you have any of the following symptoms:

    • mental status changes including agitation, hallucinations, or coma
    • fast heartbeat
    • changes in your blood pressure
    • increased body temperature
    • tight muscles
    • trouble walking

Stop taking SYMBRAVO and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • vomiting blood
  • more tired or weaker than usual
  • blood in your bowel movement or it is black and sticky like tar
  • diarrhea
  • itching, skin rash, or blisters with fever
  • unusual weight gain
  • your skin or eyes look yellow
  • indigestion or stomach pain
  • swelling of the arms, legs, hands, or feet
  • flu-like symptoms
  • tenderness in your right upper side
  • vision problems

COMMON SIDE EFFECTS

The most common side effects of SYMBRAVO include dizziness and tiredness.

These are not all the possible side effects of SYMBRAVO. Tell your doctor if you have any side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.

BEFORE USING

  • Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • It is important to tell your HCP if you are taking:

    • Propranolol containing medicines such as Inderal® LA or Innopran® XL
    • Aspirin or other anti-coagulants (blood thinners)
    • Medicines to help your mood including SSRIs and SNRIs
  • If you are unsure if you take any of these medicines, ask your HCP. They can tell you if it is safe to take SYMBRAVO with your other medicines.
  • Tell your HCP if you are pregnant or plan to become pregnant. SYMBRAVO is not recommended during pregnancy. Taking NSAIDs, including SYMBRAVO, at about 20 weeks of pregnancy or later may harm your unborn baby. NSAIDs, including SYMBRAVO, should not be taken after about 30 weeks of pregnancy.
  • Tell your HCP if you are breastfeeding or plan to breastfeed.

Tell your HCP about all your medical conditions, including if you:

  • have or have had heart problems, high blood pressure, chest pain, or shortness of breath
  • have any risk factors for heart or blood vessel problems
  • have kidney or liver problems
  • have asthma

Review the list below with your HCP. SYMBRAVO may not be right for you if:

  • take daily preventative aspirin
  • you are pregnant or plan to become pregnant
  • you are breastfeeding or plan to breastfeed

HOW TO TAKE

  • SYMBRAVO is available by prescription only.
  • Take SYMBRAVO exactly as instructed by your HCP.
  • The maximum daily dose of SYMBRAVO is 1 tablet. Talk to your HCP about what to do if your headache does not go away or comes back.
  • Take SYMBRAVO for the shortest time needed.
  • Swallow SYMBRAVO tablets whole. Do not crush, chew, or divide the tablets.
  • SYMBRAVO can be taken with or without food.
  • Do not give SYMBRAVO to other people.
  • If you take too much SYMBRAVO call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

LEARN MORE

For more information about SYMBRAVO, call 866-496-2976 or visit SYMBRAVO.com.

This summary provides basic information about SYMBRAVO but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about SYMBRAVO and how to take it. Your HCP is the best person to help you decide if SYMBRAVO is right for you.

SYM CON BS 01/2025

Please see full Prescribing Information, including Boxed Warning for risk of serious cardiovascular and gastrointestinal adverse events, and Medication Guide.

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit the Company’s website at www.axsome.com.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s Sunosi®, Auvelity®, and Symbravo® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of Sunosi, Auvelity, and Symbravo and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.

Investors:

Mark Jacobson
Chief Operating Officer
(212) 332-3243
[email protected]

Media:

Darren Opland
Director, Corporate Communications
(929) 837-1065
[email protected]

References

  1. Lipton RB, Fanning KM, et al. Ineffective acute treatment of episodic migraine is associated with new-onset chronic migraine. Neurology. 2015;84(7):688-695.
  2. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
  3. Ashina M, Katsarava Z et al. Migraine: epidemiology and systems of care. Lancet. 2021 Apr 17;397(10283):1485-1495.
  4. American Migraine Foundation. 2023.
  5. Steiner TJ et al. Migraine remains the second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137.
  6. Smelt AF, Louter MA et al. What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. PLoS One. 2014 Jun 16;9(6):e98933.
  7. Lipton RB, Stewart WF. Acute migraine therapy: do doctors understand what patients with migraine want from therapy? Headache. 1999;39(suppl 2):S20-S26.
  8. Lipton RB, Munjal S et al. Unmet Acute Treatment Needs From the 2017 Migraine in America Symptoms and Treatment Study. Headache. 2019 Sep;59(8):1310-1323.



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Ocular Therapeutix™ to Report Fourth Quarter and Full Year 2024 Results on March 3, 2025

BEDFORD, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) — Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a biopharmaceutical company committed to redefining the retina experience, today announced that it plans to host a conference call and webcast on Monday, March 3, 2025, at 8:00 AM ET to discuss recent business progress and financial results for the fourth quarter and full year ended December 31, 2024.

Conference Call and Webcast Information:

Date: Monday, March 3, 2025, at 8:00 AM ET

Participant Dial-In (U.S.): 1 (877) 407-9039

Participant Dial-in (International): 1 (201) 689-8470

Conference ID: 13750940

Webcast Access: Please click here

The live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcast will be archived for at least 30 days.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (axitinib intravitreal hydrogel, also known as OTX-TKI), Ocular’s product candidate for retinal disease, is based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD).

Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis, and in its product candidate PAXTRAVA™ (travoprost intracameral injection or OTX-TIC), which is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension.

Follow the Company on its website, LinkedIn, or X.

The Ocular Therapeutix logo and DEXTENZA® are registered trademarks of Ocular Therapeutix, Inc. AXPAXLI™, PAXTRAVA™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc.

Investors & Media

Ocular Therapeutix, Inc.
Bill Slattery
Vice President, Investor Relations
[email protected]



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Atea Pharmaceuticals Appoints Arthur S. Kirsch to Board of Directors

BOSTON, Feb. 24, 2025 (GLOBE NEWSWIRE) — Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the appointment of Arthur S. Kirsch to the Company’s Board of Directors, effective immediately. Mr. Kirsch has decades of experience in investment banking and capital markets, as well as extensive knowledge of the healthcare and life sciences industries.

Mr. Kirsch is currently a Senior Advisor with Alvarez & Marsal’s Life Sciences Industry Group, and over the course of his 30-year career has held numerous roles in mergers and acquisitions and equity capital markets at global investment banks. Over that time, he executed a wide range of strategic advisory assignments for clients in the healthcare and life sciences industries as well as numerous public and private financings.

“We are very pleased to have Arthur join our Board of Directors. His extensive financial and strategic advisory experience will further strengthen the Atea Board as we advance our strategic priorities,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea. “Arthur’s proven track record of executing and overseeing transactions will be invaluable as we pursue opportunities to enhance shareholder value, including the exploration of strategic partnerships related to our Phase 3 program, the combination of bemnifosbuvir and ruzasvir, a potentially best-in-class regimen for the treatment of hepatitis C virus.”

Since July 2019, Mr. Kirsch has served as a Senior Advisor with Alvarez & Marsal’s Life Sciences Industry Group. From June 2005 until June 2019, Mr. Kirsch served as a Managing Director and Senior Advisor for GCA Global, LLC, a global investment banking firm. From May 1994 to May 2004, he served as Head of Research at Vector Securities, LLC, a brokerage firm. Prior to that, Mr. Kirsch served as CEO of NatWest Securities Limited, where he was responsible for managing the global securities business. Mr. Kirsch began his career at Drexel Burnham Lambert, Inc., an investment banking firm.

Mr. Kirsch serves on the Board of Directors of Liquidia Technologies, Inc. (Nasdaq: LQDA). He previously served on the Board of Kadmon Holdings, Inc. (NYSE: KDMN), where he was a member of the Transaction Committee involved in overseeing its sale to Sanofi, as well as Immunomedics, POZEN Inc. and Aralez, Inc.

Mr. Kirsch received his B.A. in Finance from the University of Rhode Island and earned his MBA in Finance from Bernard M. Baruch College.

About Atea Pharmaceuticals

Atea is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Our lead program and current focus is on the development of the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor and ruzasvir, an NS5A inhibitor, to treat hepatitis C virus. For more information, please visit
www.ateapharma.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to statements regarding the contributions of Mr. Kirsch to the Atea Board of Directors and Atea’s opportunities to enhance shareholder value. When used herein, words including “expected,” “should,” “anticipated,” “believe.” “will,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, the important factors discussed under the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release.

Contacts

Jonae Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
[email protected]

Contacts

Jonae Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
[email protected]

Tim McCarthy
LifeSci Advisors
+1 917-679-9282
[email protected]



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Unity Announces Proposed $500.0 MillionOffering ofConvertible Senior Notes

Unity Announces Proposed $500.0 MillionOffering ofConvertible Senior Notes

SAN FRANCISCO–(BUSINESS WIRE)–
Unity Software Inc. (“Unity”) (NYSE: U), the leading platform to create and grow games and interactive experiences, today announced its intent to offer, subject to market conditions and other factors, $500.0 million aggregate principal amount of Convertible Senior Notes due 2030 (the “Notes”) in a private placement (the “Offering”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Unity also intends to grant the initial purchasers of the Notes an option to purchase, within a 13-day period beginning on, and including, the date on which the Notes are first issued, up to an additional $75.0 million aggregate principal amount of Notes.

The Notes will be general unsecured obligations of Unity and will accrue interest payable semiannually in arrears. Upon conversion, Unity will pay or deliver, as the case may be, cash, shares of Unity’s common stock or a combination of cash and shares of Unity’s common stock, at its election. The interest rate, initial conversion rate and other terms of the Notes will be determined at the time of pricing of the Offering.

Unity expects to use the net proceeds from the Offering to pay the cost of the capped call transactions described below and, together with cash on hand, if necessary, to repurchase for cash approximately, subject to market conditions, $500.0 million in aggregate principal amount of its 0% Convertible Senior Notes due 2026 (the “2026 Notes”) in the Note Repurchase Transactions (as described below). If the initial purchasers exercise their option to purchase additional Notes, Unity expects to use a portion of the net proceeds from the sale of the additional Notes to enter into additional capped call transactions. Unity expects to use any remaining net proceeds from the Offering for general corporate purposes, which may include additional repurchases of the 2026 Notes from time to time following the Offering, and acquisitions or strategic investments in complementary businesses or technologies (although Unity does not currently have any plans for any such acquisitions or investments), working capital, operating expenses and capital expenditures.

In connection with the pricing of the Notes, Unity expects to enter into capped call transactions with one or more of the initial purchasers or affiliates thereof and/or other financial institutions (the “Option Counterparties”). The capped call transactions will cover, subject to customary adjustments, the number of shares of Unity’s common stock initially underlying the Notes. The capped call transactions are expected generally to reduce the potential dilution to Unity’s common stock upon any conversion of Notes and/or offset any cash payments Unity is required to make in excess of the principal amount of converted Notes, as the case may be, with such reduction and/or offset subject to a cap.

In connection with establishing their initial hedges of the capped call transactions, Unity expects the Option Counterparties or their respective affiliates will enter into various derivative transactions with respect to Unity’s common stock and/or purchase shares of Unity’s common stock concurrently with or shortly after the pricing of the Notes, including with, or from, as the case may be, certain investors in the Notes. This activity could increase (or reduce the size of any decrease in) the market price of Unity’s common stock or the Notes at that time.

In addition, the Option Counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Unity’s common stock and/or purchasing or selling Unity’s common stock or other securities of Unity in secondary market transactions following the pricing of the Notes and prior to the maturity date of the Notes (and are likely to do so during the 40 trading day period beginning on the 41st scheduled trading day prior to the maturity date of the Notes, or, to the extent Unity exercises the relevant election under the capped call transactions, following any repurchase, redemption or conversion of the Notes). This activity could also cause or avoid an increase or a decrease in the market price of Unity’s common stock or the Notes which could affect a noteholder’s ability to convert the Notes and, to the extent the activity occurs during any observation period related to a conversion of Notes, it could affect the number of shares, if any, and value of the consideration that a noteholder will receive upon conversion of its Notes.

In addition, Unity expects to use a portion of the net proceeds from the offering together with cash on hand, if necessary, to repurchase for cash approximately, subject to market conditions, $500.0 million in aggregate principal amount of the 2026 Notes concurrently with the pricing of the offering in privately negotiated transactions effected through one of the initial purchasers or one of its affiliates (each, a “Note Repurchase Transaction”). The terms of each Note Repurchase Transaction will depend on a variety of factors, and each Note Repurchase Transaction will be subject to closing conditions that may not be consummated. No assurance can be given as to how many, if any, of the 2026 Notes will be repurchased or the terms on which they will be repurchased. This press release is not an offer to repurchase the 2026 Notes, and the offering of the Notes is not contingent upon the repurchase of the 2026 Notes.

In connection with any Note Repurchase Transaction, Unity expects that holders of the 2026 Notes who agree to have their 2026 Notes repurchased and who have hedged their equity price risk with respect to such Notes (the “Hedged Holders”) will unwind all or part of their hedge positions by buying Unity’s common stock and/or entering into or unwinding various derivative transactions with respect to Unity’s common stock. The amount of Unity’s common stock to be purchased by the Hedged Holders or the notional number of shares of Unity’s common stock underlying such derivative transactions may be substantial in relation to the historic average daily trading volume of Unity’s common stock. This activity by the Hedged Holders could increase (or reduce the size of any decrease in) the market price of Unity’s common stock, including concurrently with the pricing of the Notes, resulting in a higher effective conversion price for the Notes. Unity cannot predict the magnitude of such market activity or the overall effect it will have on the price of the Notes offered hereby or its common stock.

The Notes and any shares of Unity’s common stock issuable upon conversion of the Notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

Forward-Looking Statements

This press release contains “forward-looking” statements that involve risks and uncertainties regarding, among other things, the proposed Offering, including statements concerning the proposed terms and size, and the anticipated completion and timing, of the Notes, the capped call transactions, the Note Repurchase Transactions and any unwind transactions; the anticipated use of proceeds from the proposed Offering; and the potential impact of the forgoing or related transactions on dilution to holders of Unity’s common stock, the market price of our common stock or the trading price of the Notes or the conversion price of the Notes. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from Unity’s plans. These risks include, but are not limited to, market risks, trends and conditions, and those risks included in the section titled “Risk Factors” in Unity’s Securities and Exchange Commission (“SEC”) filings and reports, including its Annual Report on Form 10-K for the year ended December 31, 2024 and other filings that Unity makes from time to time with the SEC, which are available on the SEC’s website at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. Unity undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Source: Unity

Unity PR Contact:

Julianne Whitelaw

[email protected]

KEYWORDS: California North America United States Ireland United Kingdom Europe

INDUSTRY KEYWORDS: Software Technology Electronic Games Entertainment

MEDIA:

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Americas Gold & Silver Provides Galena Complex Operational and Exploration Update

Americas Gold & Silver Provides Galena Complex Operational and Exploration Update

TORONTO–(BUSINESS WIRE)–Americas Gold and Silver Corporation (“the Company”) (TSX: USA, NYSE American: USAS) is pleased to provide an update on its ongoing work programs at the Galena Complex (“Galena”) following the closing of the Galena consolidation and recapitalization transaction (the “Transaction”) closed on December 19, 2024 (see associated press release dated December 19, 2024).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250224871832/en/

Figures 1, 2, 3 & 4: New Equipment Ordered (Image credit: Americas Gold and Silver Corporation)

Figures 1, 2, 3 & 4: New Equipment Ordered (Image credit: Americas Gold and Silver Corporation)

Significant progress has been made in identifying opportunities and initiating action as part of the Company’s technical review and optimization work to ensure that the Galena Complex reaches its full production potential, underscoring the Company’s ongoing commitment to operational efficiency, safety, production growth, and maximizing value from existing assets. This progress includes initial work on the #3 shaft, a trade off study currently underway at the mine and the ordering of new mining equipment to boost productivity underground. The Company is also pleased to release new drilling results that continue to demonstrate the geologic prospectivity of the deposit and identify new veins that could be brought into production with further drilling. Lastly, as a result of an initial review of byproduct metallurgical performance, the Company has also initiated further test work to evaluate the potential to maximize recoveries of copper and antimony.

Key Highlights:

  • #3 Shaft Hoist Upgrades Underway – The Company has identified hoisting capacity as the primary bottleneck at the Galena Complex. A multi-step upgrade plan for the #3 Hoist includes increasing motor size, modifying the motor base, brake and control system improvements, and installing a down-rope shaft communication system. Completion is expected in Q4 2025​.
  • New Equipment Acquisition – To improve safety, efficiency, and productivity, the Company has ordered five new pieces of underground equipment, including one 4yd LHD, two 2yd LHDs, and two 20-ton haul trucks. Initial deliveries are expected in Q1 2025, with commissioning in Q2 2025.
  • Metallurgical Sampling in Progress – A metallurgical test program has been initiated to optimize concentrate sales by assessing by-product recovery and payability. 1,000 drill hole pulps from past Ag-Cu vein intersections have been shipped for multi-element analysis, and flotation testing is underway at SGS Laboratories in Lakefield, Canada to maximize recoveries of silver, copper, antimony, and gold​.
  • Discovery of the 049 Vein – A new high-grade silver-copper vein was intercepted while targeting the 072 vein. Notable results include up to 1,731 opt Ag (53,839 g/t) and 16.3% Cu over 0.15m true width. Three additional drill holes are in progress to further define the resource and integrate it into near-term production plans​.
  • 368 Vein Infill Drilling Program – Recent infill drilling in the 360 Complex has confirmed the continuity of economic mineralization and identified the shifting of higher grades shift into a parallel shear structure. The results support continued mining in this zone, with new development and resource conversion ongoing​.

Paul Huet, CEO of Americas Gold and Silver, commented: “The first two months of review and optimization work undertaken at the Galena Complex have been remarkably productive. I have been very impressed by the energized workforce and the tremendous potential of our primary silver asset. In my 35 years of mining, I have been fortunate to lead several operational improvement projects, and I am encouraged by both the opportunities and the commitments I have seen from the team at Galena during our first 60 days as part of the new Americas team.

Our review of the primary #3 hoisting shaft has yielded some strong near-term and longer-term upgrade projects. We have also ordered five new pieces of equipment, with initial deliveries this quarter. On the exploration front, the Galena Complex continues to demonstrate its exceptional exploration potential under the new leadership team. The discovery of the 049 Vein, along with the discovery of the new 181 & 182 Veins and the 368 Vein, reaffirms our confidence in the long-term sustainability of this asset. Finally, our review of metallurgical opportunities identified during our due diligence has led to immediate action with new sampling programs underway to optimize our concentrate by product potential by capturing previously untapped metal value.

As we move forward with these exciting programs, we remain committed to improving the productivity of the operation through a safety-focused approach. We look forward to sharing further progress on all of our initiatives in the coming months.”

Operational Revitalization through Technical Review and Optimization Projects

The Company is investing significantly both in terms of capital projects and equipment as well as management focus and operational team excellence with the aim to potentially return the Galena Complex back to historical production levels through growth and operational efficiency improvements.

Major projects already underway include:

  • Upgrades to #3 Hoist and Shaft

  • Acquisition of five new pieces of underground mobile equipment

  • Comprehensive mine-wide trade off studies

  • Metallurgical sampling program to identify by-product revenue optimization opportunities

Upgrades to #3 Hoist

Hoisting capacity has been identified as the primary bottleneck to increasing future production at the Galena Complex. Following technical review, the Company has developed a multi-step plan to begin improving productivity at the #3 Hoist, which is the primary production hoist. The project aims to boost total hoisting capacity significantly beyond the current 700tpd of total material hoisting. The four primary components to this capital improvement are:

  • Increasing motor size: The Company owns two 2,250HP motors that are currently being refurbished by a supplier in nearby Spokane, WA which will upgrade the current 1,750HP motor.
  • Upgrade the existing motor base for the new motors: A modest amount of construction work is required to modify the pedestal which holds the current motor.
  • Complete brake and Lilly upgrades: to allow for faster ascent and decent and improved operational control to optimize skip loading and hoisting cycle times.
  • Installing a down rope shaft communication system with load link: Modernizing the #3 Hoist by providing real time skip loading weights and improved hoisting controls with short interval control data collection for continual improvements to hoist safety and productivity.

The #3 hoist upgrades are expected to be complete during Q4 2025.

Equipment Acquisition & Trade Off Studies

The Company moved quickly in Q4 2024 to buy equipment and improve the existing mobile equipment fleet to provide immediate improvements to safety, efficiency, and productivity. This included securing five new pieces of equipment, further modernizing underground operations. Delivery of the equipment is expected during Q1 2025, with the equipment being rebuilt and commissioned underground in Q2 2025. The initial equipment purchase includes:

  • One 4yd LHD

  • Two 2yd LHDs

  • Two 20t Trucks

Comprehensive Mine Wide Trade Off Studies

The Company has begun a series of technical planning exercises and mine-wide trade off studies to comprehensively align the needs of mine production to the infrastructure and equipment required to unlock the improvements. These studies will utilize internal expertise as well as external consultants over the next several months and are expected to guide the Company on priority production areas, new infrastructure and upgrades to existing infrastructure. Further updates on the findings will be provided in the coming months.

Metallurgical Optimization

The Galena Complex continuously achieves excellent silver and lead recoveries; however, one of the early opportunities identified through a comprehensive audit of historical concentrate production is the opportunity to optimize concentrate sales by enhancing by-product recovery and payability. A historical analysis of shipped flotation concentrates from Galena since the year 2000 indicates significant payable by-products were present in past production. Since 2015, only a Pb/Ag concentrate has been sold, with no revenue realized for copper, antimony, or gold content. In order to better understand this opportunity, a metallurgical test program has been initiated to assess the potential of optimizing recoveries of all payable metals. The program involves:

  • 1,000 drill hole pulps from past Ag-Cu vein intersections have been shipped for multi-element analysis.

  • Flotation testing is underway at the industry leading SGS Laboratory in Lakefield, Canada, focused on:

    • Maximizing recoveries of silver, copper, antimony, and gold.

    • Evaluating the viability of differential flotation to generate separate Pb/Ag and Cu/Ag concentrates.

Results from the metallurgical study will be used to guide future mill process improvements providing potential revenue enhancements.

Operational Excellence

The management team and the board strongly believe in the full potential of the Galena Complex and are dedicated to unlocking its existing potential. This commitment has been evident since the closing of the Transaction with the continuous presence of the executive team on site and the addition of a number of new hires to both the corporate and management team on site providing real-time training support to mine leadership and operations. These early actions are necessary to create a step change in performance at the operation. The team has successfully improved data collection and reporting which has led to a number of modifications to existing procedures to improve task execution and efficiency. The new focused approach has generated several quick wins and has begun to build a culture of operational team excellence on site where all employees participate in idea generation and execution of new processes. The results and responses to date have been positive.

Exploration Update

Recent drilling campaigns have identified three new potentially economic veins as well as completing a successful infill program to de-risk near term production. The strong exploration results are reflective of the high exploration potential and geologic endowment at the Galena Complex, leading to the discovery of the 049, 181 and 182 veins. The 368 vein has also been successfully infill drilled ahead of production.

Discovery of 049 Vein at 5500 Galena Diamond Drill Station

A previously undiscovered vein was intercepted while targeting the 072 vein. The new 049 vein has returned exceptional silver and copper grades. Geologic modeling identified eight additional intercepts along the vein structure as outlined in the results below. Three additional drill holes are in progress to further define the potential resource and to create mining plans to add this high-grade area into near term production. New high-grade silver veins continue to be discovered at Galena, reinforcing the long-term potential of the operation. The most significant intercepts through the 049 vein are:

  • Hole 52-514: 6,246 g/t (200.8 opt) silver, 1.7% copper over 0.49 m true width[1]
  • Hole 52-550: 7,853 g/t(252.5 opt) silver, 2.3% copper over 0.27 m true width[1]
  • Hole 52-553: 53,839 g/t (1,731.0 opt) silver, 16.3% copper over 0.15 m true width[1]

The 049 vein was initially encountered in a previously reported interval on January 23, 2024 in hole 52-507 containing:

  • Hole 52-507: 6442.1 g/t (207.2 opt) silver and 1.8% copper over 0.37 m true width[1]

181 & 182 Vein Discovery

Drilling from the 49-132 Loop 5 diamond drill station identified two new parallel silver-lead (Ag/Pb) veins situated near the 4900 Ramp system, approximately 15 meters (50 feet) northeast of the drill station. Development access has since crosscut these veins, and initial mining has commenced. Mining plans have been adjusted to incorporate this discovery as a new production stope and development is in progress.

The 181/182 veins were discovered in 2024 and the geology was immediately identified as having a positive significant impact on mining and production. The veins are open at depth and above with both extensional and infill drilling scheduled for later this year. From the next drill station on 4600L, which is located in an actively producing mining area. The Company is confident in the potential to extend the size of these two prospective vein areas.

368 Vein Infill Drilling Program

The 360 Complex is an active mining area in the eastern portion of the mine currently accessed from the 4900L. The 360 Complex has contributed profitable tons over the past several years as the ramp system has developed up towards the 4600L. An infill program confirmed the continuation of economic mineralization following the structure up dip of the 360 Vein, with higher grades appearing to jump to a parallel vein structure within a broader shear zone which is currently an active significant production area. Highlighted drill results include:

  • Hole 49-768: 353 g/t (10.3 opt) silver, 9.8% lead over 2.65 m true width[1]
  • Hole 49-764: 302 g/t (8.8 opt) silver, 9.2% lead over 2.04 m true width[1]

Ongoing infill drilling to convert resources also demonstrate grade increases to the west of the current mining area. Current forecasted grade and tons represents a significant source of feed material to support the planned increase in mined and milled tons as part of the planned revitalization of Galena.

A full table of drill results can be found at: https://americas-gold.com/site/assets/files/4297/dr20250224.pdf

About Americas Gold and Silver Corporation

Americas Gold and Silver is a growing precious metals mining company with multiple assets in North America. The Company owns and operates the Cosalá Operations in Sinaloa, Mexico, and in December 2024, the Company acquired 100% ownership in the Galena Complex (located in Idaho, USA) in a transaction with Eric Sprott and a Paul Huet-led management team, further strengthening its position as a leading silver producer. Eric Sprott is now the largest shareholder in the company, holding a ~20% interest. Additionally, the Company owns the San Felipe development project in Sonora, Mexico. With these strategically positioned assets, Americas Gold and Silver is striving to become one of the top North American silver-focused producers with an objective of over 80% of its revenue generated from silver by the end of 2025.

Technical Information and Qualified Persons

The scientific and technical information relating to the operation of the Company’s material operating mining properties contained herein has been reviewed and approved by Chris McCann, P.Eng., VP Technical Services of the Company. The Company’s current Annual Information Form and the NI 43-101 Technical Reports for its other material mineral properties, all of which are available on SEDAR at www.sedar.com, and EDGAR at www.sec.gov, contain further details regarding mineral reserve and mineral resource estimates, classification and reporting parameters, key assumptions and associated risks for each of the Company’s material mineral properties, including a breakdown by category.

The diamond drilling program used NQ-size core and BQ-size core. The Company’s standard QA/QC practices were utilized to ensure the integrity of the core and sample preparation at the Galena Complex through delivery of the samples to the assay lab. The drill core was stored in a secure facility, photographed, logged and sampled based on lithologic and mineralogical interpretations. Standards of certified reference materials, field duplicates and blanks were inserted as samples shipped with the core samples to the lab.

Analytical work was carried out by American Analytical Services Inc. (“AAS”) located in Osburn, Idaho. AAS is an independent, ISO-17025 accredited laboratory. Sample preparation includes a 30-gram pulp sample analyzed by atomic absorption spectrometry (“AA”) techniques to determine silver, copper, and lead, using aqua regia for pulp digestion. Samples returning values over 514g/t Ag are re-assayed using fire-assay techniques for silver. Additionally, samples returning values over 23% Pb are re-assayed using titration techniques.

Duplicate pulp samples were sent out quarterly to ALS Global, an independent, ISO-17025 accredited laboratory based in Reno, Nevada to perform an independent check analysis. A conventional AA technique was used for the analysis of silver, copper and lead at ALS Global with the same industry standard procedures as those used by AAS. The assay results listed in this report did not show any significant contamination during sample preparation or sample bias of analysis.

All mining terms used herein have the meanings set forth in National Instrument 43-101 – Standards of Disclosure for Mineral Projects (“NI 43-101”), as required by Canadian securities regulatory authorities. These standards differ from the requirements of the SEC that are applicable to domestic United States reporting companies. Any mineral reserves and mineral resources reported by the Company in accordance with NI 43-101 may not qualify as such under SEC standards. Accordingly, information contained in this news release may not be comparable to similar information made public by companies subject to the SEC’s reporting and disclosure requirements.

Cautionary Statement on Forward-Looking Information:

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information includes, but is not limited to, Americas expectations, intentions, plans, assumptions and beliefs with respect to, among other things, estimated and targeted production rates and results for gold, silver and other metals, the expected prices of gold, silver and other metals, as well as the related costs, expenses and capital expenditures; Company’s technical review and optimization work at the Galena Complex; operational improvements and production from the Galena Complex, including the expected production levels and anticipated improvements through production growth and operational efficiency, and potential additional mineral resources thereat; the expected timing and completion of the Galena hoist and shaft improvements, mine-wide trade-off studies and equipment upgrades and the expected operational and production results therefrom, including the anticipated improvements to total capacity and operational efficiency, to the cash costs per silver ounce and all-in sustaining costs per silver ounce at the Galena Complex following completion; opportunities relating to the optimization of concentrate sales by enhancing by-product recovery and payability; and the timing and results of its metallurgical sampling program to identify by-product revenue optimization opportunities and the anticipated improvements therefrom; and the initial results and expectations arising out of the Company’s exploration and drilling programs at the Galena Complex. Often, but not always, forward-looking information can be identified by forward-looking words such as “anticipate”, “believe”, “expect”, “goal”, “plan”, “intend”, “potential’, “estimate”, “may”, “assume” ‘ensure” and “will” or similar words suggesting future outcomes, or other expectations, beliefs, plans, objectives, assumptions, intentions, or statements about future events or performance. Forward-looking information is based on the opinions and estimates of Americas as of the date such information is provided and is subject to known and unknown risks, uncertainties, and other factors that may cause the actual results, level of activity, performance, or achievements of Americas to be materially different from those expressed or implied by such forward-looking information. With respect to the business of Americas , these risks and uncertainties include risks relating to widespread epidemics or pandemic outbreak; interpretations or reinterpretations of geologic information; unfavorable exploration results; inability to obtain permits required for future exploration, development or production; general economic conditions and conditions affecting the industries in which the Company operates; the uncertainty of regulatory requirements and approvals; potential litigation; fluctuating mineral and commodity prices; the ability to obtain necessary future financing on acceptable terms or at all; the ability to operate the Company’s projects; and risks associated with the mining industry such as economic factors (including future commodity prices, currency fluctuations and energy prices), ground conditions, illegal blockades and other factors limiting mine access or regular operations without interruption, failure of plant, equipment, processes and transportation services to operate as anticipated, environmental risks, government regulation, actual results of current exploration and production activities, possible variations in ore grade or recovery rates, permitting timelines, capital and construction expenditures, reclamation activities, labor relations or disruptions, social and political developments, risks associated with generally elevated inflation and inflationary pressures, risks related to changing global economic conditions, and market volatility, risks relating to geopolitical instability, political unrest, war, and other global conflicts may result in adverse effects on macroeconomic conditions including volatility in financial markets, adverse changes in trade policies, inflation, supply chain disruptions and other risks of the mining industry. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated, or intended. Readers are cautioned not to place undue reliance on such information. Additional information regarding the factors that may cause actual results to differ materially from this forward‐looking information is available in Americas filings with the Canadian Securities Administrators on SEDAR and with the SEC. Americas does not undertake any obligation to update publicly or otherwise revise any forward-looking information whether as a result of new information, future events or other such factors which affect this information, except as required by law. Americas does not give any assurance (1) that Americas will achieve its expectations, or (2) concerning the result or timing thereof. All subsequent written and oral forward‐looking information concerning Americas are expressly qualified in their entirety by the cautionary statements above.

1 Meters represent “True Width” which is calculated for significant intercepts only and is based on orientation axis of core across the estimated dip of the vein.

For further information, please contact:

Maxim Kouxenko – Manager, Investor Relations

M: +1(647) 888-6458

E: [email protected]

W: americas-gold.com

KEYWORDS: Idaho United States North America Canada

INDUSTRY KEYWORDS: Mining/Minerals Natural Resources

MEDIA:

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Figures 1, 2, 3 & 4: New Equipment Ordered (Image credit: Americas Gold and Silver Corporation)
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Figure 5: Long section of Galena Complex (Image credit: Americas Gold and Silver Corporation)
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Figure 6: 049 Vein Cross Section (Image credit: Americas Gold and Silver Corporation)
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Figure 7: 181 & 182 Veins Section View (Image credit: Americas Gold and Silver Corporation)
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AN2 Provides Strategic Update for Phase 3 EBO-301 Trial in Treatment Refractory MAC Lung Disease

AN2 Provides Strategic Update for Phase 3 EBO-301 Trial in Treatment Refractory MAC Lung Disease

AN2 Selects QOL-B as New Phase 3 Primary Efficacy Endpoint

Goal to Accelerate Unblinding Phase 3 Data in Q2 2025 Ahead of Potential FDA Meeting

MENLO PARK, Calif.–(BUSINESS WIRE)–
AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, today announced its submission of an amended statistical analysis plan to the FDA selecting the Quality of Life – Bronchiectasis (QOL-B) respiratory domain patient reported outcome (PRO) instrument as the primary efficacy endpoint for the Phase 3 part of the EBO-301 trial. The Company will evaluate whether the Phase 3 data supports the Phase 2 findings, where potential clinical proof-of-concept was shown. The Company plans to review both Phase 2 and Phase 3 results with the FDA and discuss potential registrational pathways.

“In Phase 2, we observed potentially meaningful clinical improvement in a highly refractory population. The FDA has made it clear that the primary bar for NTM drug approval is patient-reported improvement in NTM symptoms. Our recent statistical analysis plan submission provides the opportunity to seek FDA input on our selection of QOL-B as the new primary efficacy endpoint prior to unblinding the Phase 3 data and requesting a formal meeting,” said Eric Easom, Co-Founder, President and Chief Executive Officer. “Should the Phase 3 data confirm the Phase 2 findings, we plan to meet with the FDA to discuss potential registrational pathways in this highly refractory population with minimal to no treatment options.”

QOL-B Respiratory Domain PRO as Revised Primary Endpoint Follows Recent Precedent of Arikayce Confirmatory ENCORE Study

Based on the results of the Phase 2 study, the Company has updated the Phase 3 portion of the statistical analysis plan to designate the QOL-B respiratory domain PRO score change from baseline to treatment at month 6 (least squares mean analysis) as the primary Phase 3 endpoint. The Company believes that this approach aligns with current FDA Guidance for Industry on NTM drug development regarding the use of a clinical outcome measure as the sole primary endpoint and, it also follows the precedent established by Insmed’s confirmatory study of Arikayce in treatment-naïve MAC patients, where the same QOL-B instrument has been reported as the primary efficacy measure. The Company intends to release topline Phase 3 results in the second quarter of 2025, subject to the timing of any potential FDA response.

About the QOL-B Respiratory Domain PRO Endpoint

FDA’s 2023 Guidance for Industry on NTM drug development recommends PRO-based clinical outcome measures as the primary efficacy endpoint in registrational trials. The primary purpose of the Phase 2 part of the EBO-301 study was to test the validity of multiple patient-reported outcome tools in a treatment refractory population, with the goal of identifying a PRO-based primary endpoint for the Phase 3 portion of the trial.

Using QOL-B as a continuous measure of clinical improvement, epetraborole showed nominal statistical superiority versus placebo in change from baseline to month 6 in the Phase 2 portion of the trial (prespecified secondary endpoint, difference in least squares mean change from baseline: 6.90, p=0.0365). Furthermore, a post-hoc analysis of the MACrO2 PRO using a 100-point continuous scale similar to QOL-B, showed a comparable nominally statistically superior result for the epetraborole arm versus the placebo arm (difference in least squares mean change from baseline: 5.81, p=0.0433). Blinded psychometric analyses incorporating the data from both treatment arms of the Phase 2 study demonstrated strong evidence for the reliability, validity, ability to detect change (responsiveness), and clinically meaningful within-patient changes in both the QOL-B respiratory domain score and the post hoc MACrO2 total scaled score, suggesting that the scores measured from either PRO may be fit-for-purpose in evaluating response to treatment in patients with treatment-refractory NTM lung disease.

The Company reported Phase 2 topline results in August 2024, where it also announced termination of the ongoing Phase 3 portion of the trial. The Company also initiated a full review of the Phase 2 data and an assessment of pathways for continued development in TR-MAC. Ninety-seven subjects completed treatment in Phase 3, the data for which remains blinded and available for analysis as a Phase 3 dataset.

For more information about the EBO-301 study, please visit: www.clinicaltrials.gov (NCT05327803).

About AN2 Therapeutics, Inc.

AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, NTM, and melioidosis, along with early-stage programs focused on targets in infectious diseases and oncology. For more information, please visit our website at www.an2therapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: changes to the primary efficacy endpoint for the Phase 3 part of the EBO-301 trial; regulatory meetings and pathways and alignment with and interpretations of FDA guidance; the Company’s plans to unblind and release top-line results from the Phase 3 data in the second quarter of 2025; the potential of the Company’s boron chemistry platform and early-stage pipeline programs; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: future trials and data readouts of epetraborole in NTM-MAC and the ability to show clinical efficacy consistent with PRO-based data observed in prospective and post-hoc analyses to date; potential disruptions related to AN2’s ability to implement its plans for its internal boron chemistry platform and early-stage pipeline programs; timely enrollment of patients in AN2’s existing and future clinical trials; disruptions at the FDA and other government agencies caused by funding shortages, staff reductions and statutory, regulatory and policy changes; AN2’s ability to procure sufficient supply of its product candidates for its existing and future clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; continued funding by the National Institute of Allergy and Infectious Disease (NIAID) of AN2’s development program for melioidosis; AN2’s ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading “Risk Factors” in AN2’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, and AN2’s other reports filed with the U.S. Securities and Exchange Commission(SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.

COMPANY CONTACT:

Lucy O. Day

Chief Financial Officer

[email protected]

INVESTOR AND MEDIA CONTACT:

Anne Bowdidge

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Health FDA Infectious Diseases Clinical Trials

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PepGen Announces Positive Initial Results, Including Robust Splicing Correction, from Ongoing FREEDOM-DM1 Trial in Patients with DM1

PepGen Announces Positive Initial Results, Including Robust Splicing Correction, from Ongoing FREEDOM-DM1 Trial in Patients with DM1

– Significant mean splicing correction of 29.1% following a single dose of PGN-EDODM1 at 10 mg/kg –

– PGN-EDODM1 observed to have favorable emerging safety profile –

– Conference call scheduled today at 8:00 a.m. ET –

BOSTON–(BUSINESS WIRE)–
PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced initial positive clinical data from the 5 and 10 mg/kg dose cohorts in the ongoing FREEDOM-DM1 Phase 1 trial investigating PGN-EDODM1 in myotonic dystrophy type 1 (DM1).

“These results far exceeded our expectations for splicing correction following a single dose of PGN-EDODM1. Mis-splicing is the underlying cause of DM1 pathology, and we believe the mean splicing correction observed at 28 days following a single dose of PGN-EDODM1 at 10 mg/kg in the FREEDOM clinical trial surpasses those reported to date in multi-dose clinical trials of up to nine months in duration in patients with DM1. We believe this is a strong indicator of our EDO technology’s potential to deliver therapeutic oligonucleotides to the nucleus and PGN-EDODM1’s potential to address the underlying cause of disease,” said James McArthur, PhD, President and CEO of PepGen. “We believe these results provide initial validation of PGN-EDODM1’s ability to selectively bind the pathogenic CUG-repeat DMPK RNA and we look forward to evaluating PGN-EDODM1 with more doses over longer time periods in our FREEDOM2-DM1 multiple ascending dose study. Based on these initial results, we aim to build on the significant correction of mis-splicing observed in this single-dose study to potentially provide improved functional benefit for patients who currently have no available approved therapeutic options.”

FREEDOM Results for the 5 mg/kg (n=8) and 10 mg/kg (n=8) Dose Cohorts

Splicing, Muscle Tissue Concentration and Functional Data:

  • Mean splicing correction from evaluable participants was 12.3% and 29.1% at 5 mg/kg (n=6) and at 10 mg/kg (n=4)1,2, respectively, as measured by the 22-gene panel3 at 28 days post-dosing.

  • Dose-dependent increase in muscle tissue concentrations of PGN-EDODM1 was observed at 5 mg/kg (n=6) and at 10 mg/kg (n=5)1 at day 28.

  • While single-dose studies have not demonstrated improved functional outcomes in DM1 patients, the Company collected data from these cohorts and believes these data showed positive early trends in some functional outcome measures. The Company believes robust splicing correction with PGN-EDODM1 has the potential to lead to meaningful functional improvements with repeat dosing over time.

Safety and Tolerability Data:

  • PGN-EDODM1 was observed to have a favorable emerging safety profile in the 5 and 10 mg/kg cohorts through the data cut-off date of December 3, 2024, which has continued through the date of this release. There were no adverse events related to electrolytes or renal biomarkers. Most of the treatment emergent adverse events were mild or moderate in severity.

  • There was one treatment-related serious adverse event of abdominal pain in the 10 mg/kg cohort that was potentially confounded by use of a prohibited, off-label drug taken on the morning of PGN-EDODM1 dosing.

“These initial results from the FREEDOM clinical trial are highly encouraging. The emerging safety profile is very promising. The dose-dependent splicing correction may suggest that the drug gets into the muscle and effectively binds to the target. Mis-splicing is central to the cause of DM1, and correcting mis-splicing may improve functional outcomes for DM1 patients over time. With this in mind, I am particularly excited by the levels of splicing correction seen after only a single dose of PGN-EDODM1. Based on previous work, I believe that these effects could be stronger as levels of the drug build up with repeat dosing,” said Dr. Johanna Hamel, Associate Professor of Neurology, Pathology and Laboratory Medicine at the University of Rochester Medical Center.

The Company expects to report results from the FREEDOM 15 mg/kg cohort in the second half of 2025 and from the FREEDOM2 5 mg/kg cohort in the first quarter of 2026.

Conference Call Details

PepGen will host a conference call and webcast today at 8:00 a.m. ET to review the FREEDOM data. To access the call, please dial (800) 218-2154 and provide the Conference ID 8807881. A live webcast of the presentation will be available on the Events & Presentations section of the PepGen investor website, investors.pepgen.com.

About PGN-EDODM1

PGN-EDODM1, PepGen’s investigational candidate in development for the treatment of DM1, utilizes the Company’s proprietary EDO technology to deliver a therapeutic oligonucleotide that is designed to restore the normal splicing function of MBNL1, a key RNA splicing protein. PGN-EDODM1 is designed to directly address the deleterious effects of cytosine-uracil-guanine (CUG) repeat expansion in the dystrophia myotonica protein kinase (DMPK) transcripts which sequester MBNL1, by binding to the pathogenic CUG trinucleotide repeat expansion present in the DMPK transcripts, disrupting the binding between the CUG repeat expansion and MBNL1. We believe this mechanism will allow the DMPK transcripts to continue performing their normal function within the cell, while also liberating MBNL1 to correct downstream mis-splicing events. We believe that this innovative therapeutic approach has considerable advantages over oligonucleotide modalities that rely on knockdown or degradation of the DMPK transcripts. The U.S. Food and Drug Administration has granted PGN-EDODM1 both Orphan Drug and Fast Track Designations for the treatment of patients with DM1.

About the FREEDOM Clinical Program

FREEDOM-DM1 is a multinational, randomized, double-blind, placebo-controlled Phase 1 single ascending dose study, enrolling up to approximately 32 adult participants with DM1 in multiple geographies including the United States, the United Kingdom and Canada, to evaluate the safety and tolerability of PGN-EDODM1. Per the protocol, PGN-EDODM1 was administered at starting doses of 5 mg/kg and 10 mg/kg with subsequent dose escalation to 15 mg/kg, and potentially in the future to 20 mg/kg, based upon evaluation by a safety committee of safety data from the prior dose cohort(s). Muscle biopsies are being conducted at baseline, at day 28 and at week 16. In addition to safety and tolerability, oligonucleotide muscle concentrations, splicing correction and functional outcome measures are being assessed at day 28 and at week 16 following a single dose of PGN-EDODM1.

FREEDOM2-DM1 is a Phase 2 randomized, double-blind, placebo-controlled, multiple ascending dose clinical trial evaluating PGN-EDODM1 in approximately 24 adult participants with DM1 in Canada, the United Kingdom, and potentially other geographies, including the United States, subject to regulatory clearances.

About Myotonic Dystrophy Type 1

Myotonic dystrophy type 1 is a monogenic, autosomal dominant, progressive disorder that primarily affects skeletal, cardiac and smooth muscles, with central nervous system symptoms also being evident. Globally, the prevalence of DM1 is estimated to be 1 in 8,000 people, with approximately 40,000 patients in the United States, 75,000 patients in Europe and 15,000 patients in Japan.

DM1 patients can suffer from various manifestations of disease including myotonia, or a temporary rigidity due to the inability to relax muscles, muscle weakness, cardiac abnormalities, respiratory problems, fatigue, gastrointestinal complications, early cataracts, and cognitive and behavioral impairments. For patients with more severe forms of DM1, life expectancy is reduced due to increased mortality rates resulting from pulmonary and cardiac complications.

About PepGen

PepGen Inc. is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.

For more information, please visit www.pepgen.com. Follow PepGen on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the therapeutic potential and safety profile of PGN-EDODM1, including as it relates to data from the 5 and 10 mg/kg cohorts of the FREEDOM-DM1 study, the potential of our EDO platform to deliver higher levels of oligonucleotide to the nuclei, our expectations regarding the potential for significant correction of mis-splicing with more doses of PGN-EDODM1 over a longer treatment period to potentially provide improved functional benefit for patients with DM1, the expected timing for additional data reports from our FREEDOM trial and the initial data report from our FREEDOM2-DM1 trial, any functional improvements that may result from robust splicing correction with PGN-EDODM1, dose-dependent increases in splicing suggesting that PGN-EDODM1 is getting into the muscle and effectively binding to the target, and ongoing and planned regulatory interactions.

Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to risks related to: delays or failure to successfully initiate or complete our ongoing and planned development activities for our product candidates, including PGN-EDODM1; our ability to enroll patients in our clinical trials, including FREEDOM and FREEDOM2; that our interpretation of clinical and preclinical study results may be incorrect, or that we may not observe the levels of therapeutic activity in clinical testing that we anticipate based on prior clinical or preclinical results; our product candidates, including PGN-EDODM1, may not be safe and effective or otherwise demonstrate safety and efficacy in our clinical trials; adverse outcomes from our regulatory interactions, including delays in regulatory review, clearance to proceed or approval by regulatory authorities with respect to our programs, including clearance to commence planned clinical studies of our product candidates, or other regulatory feedback requiring modifications to our development programs, including in each case with respect to our FREEDOM and FREEDOM2 programs; changes in regulatory framework that are out of our control; unexpected increases in the expenses associated with our development activities or other events that adversely impact our financial resources and cash runway; and our dependence on third parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning PepGen’s programs and operations are described in our most recent annual report on Form 10-K that is filed with the SEC. PepGen explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

This release discusses PGN-EDODM1, an investigational therapy that has not been approved for use in any country, and is not intended to convey conclusions about its efficacy or safety. There is no guarantee that PGN-EDODM1 or any other investigational therapy will successfully complete clinical development or gain regulatory authority approval.

  1. One participant’s biopsy was not collected at day 28 due to pseudoaneurysm in connection with the biopsy procedure.

  2. One participant’s sample showed a splicing index outside the pre-specified assay range at both baseline and day 28 (no detectable mis-splicing) and was excluded from the analysis.

  3. Provenzano et al., The Splice Index as a prognostic biomarker of strength and function in myotonic dystrophy type 1, J Clin. Invest. 2025

 

Investor Contact

Dave Borah, CFA

SVP, Investor Relations and Corporate Communications

[email protected]

Media Contact

Julia Deutsch

Lyra Strategic Advisory

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Health Neurology Clinical Trials Research Science Biotechnology

MEDIA:

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NMG to Present at BMO’s Global Metals, Mining and Critical Minerals Conference

NMG to Present at BMO’s Global Metals, Mining and Critical Minerals Conference

MONTRÉAL–(BUSINESS WIRE)–
Nouveau Monde Graphite Inc.’s (“NMG” or the “Company”) (NYSE: NMG, TSX: NOU) leadership team is participating this week in BMO’s 34th Global Metals, Mining and Critical Minerals Conference in Hollywood, Florida, to position its integrated graphite operation in capital markets. NMG’s ore-to-active-anode-material Phase 2, comprised of the future Matawinie Mine and Bécancour Battery Material Plant, is key to North America’s effort to reshore production of critical minerals for the energy sector.

BMO Capital Markets’ 34th annual Global Metals, Mining & Critical Minerals Conference attracts some 600 capital providers. Founder, President and CEO Eric Desaulniers will be presenting to institutional investors on Tuesday, February 25, at 11:00 a.m. EST. The presentation will be webcasted live and made available shortly thereafter for on-demand viewing on NMG’s website (Investing section).

About Nouveau Monde Graphite

Nouveau Monde Graphite is an integrated company developing responsible mining and advanced processing operations to supply the global economy with carbon-neutral active anode material to power EV and renewable energy storage systems. The Company is developing a fully integrated ore-to-battery-material source of graphite-based active anode material in Québec, Canada. With enviable ESG standards and structuring partnerships with anchor customers, NMG is set to become a strategic supplier to the world’s leading lithium-ion battery and EV manufacturers, providing high-performing and reliable advanced materials while promoting sustainability and supply chain traceability. www.NMG.com

Subscribe to our news feed: https://bit.ly/3UDrY3X

CautionaryNoteRegardingForward-LookingInformation

This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable securities legislation (collectively, “forward-looking statements”), including, but not limited to, statements relating to future events or future financial or operating performance of the Company and reflect management’s expectations and assumptions regarding the Company’s growth, results, performance and business prospects and opportunities. Such forward-looking statements reflect management’s current beliefs and are based on information currently available to it. These forward-looking statements include, but are not limited to, the Company’s ability to develop a fully integrated ore-to-battery-material source of graphite-based active anode material in the Province of Québec, to become a strategic supplier to the world’s leading lithium-ion battery and EV manufacturers, to provide high-performing and reliable advanced materials while promoting sustainability and supply chain traceability, and to position its integrated graphite operation in capital markets, the Company’s future role in supporting North America’s efforts to reshore critical mineral production, reducing dependency on foreign supply chains and strengthening the continent’s energy transition, the expected results of the initiatives described in this press release, and those statements which are discussed under the “About Nouveau Monde” paragraph and elsewhere in the press release which essentially describe the Company’s outlook and objectives.

Forward-looking statements are based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions are not guarantees of future performance and may prove to be incorrect. Moreover, these forward-looking statements are based upon various underlying factors and assumptions, including the current technological trends, the business relationship between the Company and its stakeholders, the ability to obtain sufficient financing for the development of the Matawinie Mine and the Bécancour Battery Material Plant, the Company’s ability to provide high-performing and reliable advanced materials while promoting sustainability and supply chain traceability, the consumers demand for components in lithium-ion batteries for EVs and energy storage solutions, the ability to operate in a safe and effective manner, the timely delivery and installation at estimated prices of the equipment supporting the production, assumed sale prices for graphite concentrate, the accuracy of any Mineral Resource estimates, future currency exchange rates and interest rates, political and regulatory stability, prices of commodity and production costs, the receipt of governmental, regulatory and third party approvals, licenses and permits on favorable terms, sustained labor stability, stability in financial and capital markets, availability of equipment and critical supplies, spare parts and consumables, the various tax assumptions, CAPEX and OPEX estimates, all economic and operational projections relating to the project, local infrastructures, the Company’s business prospects and opportunities and estimates of the operational performance of the equipment.

Forward-looking statements are subject to known or unknown risks and uncertainties that may cause actual results to differ materially from those anticipated or implied in the forward-looking statements. Risk factors that could cause actual results or events to differ materially from current expectations include, among others, delays in the scheduled delivery times of the equipment, the ability of the Company to successfully implement its strategic initiatives and whether such strategic initiatives will yield the expected benefits, the availability of financing or financing on favorable terms for the Company, the dependence on commodity prices, the impact of inflation on costs, the risks of obtaining the necessary permits, the operating performance of the Company’s assets and businesses, competitive factors in the graphite mining and production industry, changes in laws and regulations affecting the Company’s businesses, political and social acceptability risk, environmental regulation risk, currency and exchange rate risk, technological developments, the impacts of the global COVID-19 pandemic and the governments’ responses thereto, and general economic conditions, as well as earnings, capital expenditure, cash flow and capital structure risks and general business risks. A further description of risks and uncertainties can be found in NMG’s Annual Information Form dated March 27, 2024, including in the section thereof captioned “Risk Factors”, which is available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Unpredictable or unknown factors not discussed in this Cautionary Note could also have material adverse effects on forward-looking statements.

There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.

Further information regarding the Company is available in the SEDAR+ database (www.sedarplus.ca), and for United States readers on EDGAR (www.sec.gov), and on the Company’s website at: www.NMG.com

MEDIA

Julie Paquet

VP Communications & ESG Strategy

+1-450-757-8905 #140

[email protected]

INVESTORS

Marc Jasmin

Director, Investor Relations

+1-450-757-8905 #993

[email protected]

KEYWORDS: Florida United States North America Canada

INDUSTRY KEYWORDS: EV/Electric Vehicles Other Energy Mining/Minerals Batteries Alternative Energy Energy General Automotive Technology Automotive Natural Resources Automotive Manufacturing Manufacturing

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