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I won't be too surprised if ICCM
eod in the green.
Well, that's a good start anyway, and the market
sure is positively noticing the company as the
rising sp indicates.
Time will tell if RDHL sp momentum continues!
I for one am cautiously optimistic!
$RDHL RedHill Biopharma
https://finance.yahoo.com/news/three-undiscovered-gems-united-states-150814759.html
Overview: RedHill Biopharma Ltd. is a specialty biopharmaceutical company that primarily focuses on gastrointestinal and infectious diseases, with a market cap of $256.99 million.
Operations: RedHill Biopharma Ltd. derives its revenue from the sale of specialty biopharmaceutical products targeting gastrointestinal and infectious diseases. The company has a market cap of $256.99 million.
RedHill Biopharma, a small cap stock, recently reported a significant one-off gain of US$54.6M for the year ending December 31, 2023. The company is debt-free and has maintained this status for over five years. Despite becoming profitable last year, its share price has been highly volatile over the past three months. Recent developments include the launch of Talicia in the UAE and positive results from studies on opaganib for Type 2 diabetes treatment.
9.26 +0.73 (+8.66%)
As of 10:13 AM EDT. Market Open
Cool.
Talicia® Launched in the United Arab Emirates
https://finance.yahoo.com/news/talicia-launched-united-arab-emirates-110000964.html
In this article:
RedHill's Talicia, the first approved low-dose rifabutin-containing all-in-one combination treatment for H. pylori, is now available on prescription to treat adults with H. pylori infection in the United Arab Emirates (UAE)
The commercial launch of Talicia triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales
Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[1] for the treatment of H. pylori, a bacterial infection that affects 41% of the UAE population[2] and over 50% of the world's adult population[3]
RALEIGH, N.C., Aug. 21, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the launch of Talicia (omeprazole magnesium, amoxicillin and rifabutin)[4] in the United Arab Emirates (UAE) – making it available by prescription to treat adults with Helicobacter pylori (H. pylori) infection. The commercial launch of Talicia in the UAE triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales. Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori.
"We are delighted with the commercial launch of Talicia in the UAE, bringing this important medicine to patients in the region," said Rick Scruggs, President, RedHill Biopharma Inc. & Chief Commercial Officer. "As one of the strongest risk factors for gastric cancer, H. pylori is a major public health concern. With 41% of the UAE population infected by H. pylori and the alarming failure rates of clarithromycin-based therapies[5],[6], there is a significant medical need for a highly effective first-line H. pylori therapy. Our efforts to make Talicia available to patients in more countries continue as we work to explore additional opportunities with existing and potential partners."
Clarithromycin-based triple therapy continues to wane in effectiveness. A 2021 study demonstrated only 68.5% eradication with traditional clarithromycin-based triple therapy, which declined further to 32% in patients harboring resistant H. pylori organisms[7]. Clarithromycin-based treatment efficacy can also be negatively impacted by patient obesity or diabetic status, neither of which impact Talicia's safety or efficacy, according to data from post-approval post-hoc analysis[8],[9].
About H. pylori
H. pylori is a bacterial infection that affects approximately 35%[10] of the U.S. population, with an estimated two million patients treated annually[11]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[12] and a major risk factor for peptic ulcer disease[13] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[14]. More than 27,000 Americans are diagnosed with gastric cancer annually[15]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[16].
About Talicia
Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[17] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[18].
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION
Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.
Talicia is contraindicated in patients receiving rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia.
Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (=1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for Talicia is available at www.Talicia.com
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[19], and Aemcolo®, for the treatment of travelers' diarrhea in adults[20]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
More information about the Company is available at www.redhillbio.com / twitter.com/RedHillBio.
8.21 +0.18 (+2.22%)
As of 1:46 PM EDT. Market Open.
This i did not expect!!!
Indeed we do. Hopefully it is a Marathon run.
7.98 -0.05 (-0.59%)
As of 11:36 AM EDT. Market Open.
Now, that is a very pleasant surprise.
If/when FDA aaproval achieved, it is possible.
Until then, hopefuly sales will continue growing,
othewise some sort of partnership from BP will
serve a good enough sp catalyst.
Unless some good news, RDHL
is doomed!
0.7266 +0.0866 (+13.6722%)
As of 10:39 AM EDT. Market Open.
Volume 920,551
Avg. Volume 423,164
https://ih.advfn.com/stock-market/NASDAQ/biolinerx-BLRX/stock-news/94408736/form-6-k-report-of-foreign-issuer-rules-13a-16
Item 3
3.To approve an increase in the Company’s authorized share capital, and to amend the Company’s Articles of Association accordingly
For an eventual offering?!
IceCure Medical Reports 20% Growth in ProSense® System and Probe Sales for the First Half of 2024; Reflects Continued Adoption in the U.S. and Other Global Markets
https://finance.yahoo.com/news/icecure-medical-reports-20-growth-123000882.html
Near-term regulatory and operating catalysts have potential to accelerate adoption of ProSense® for treatment of early-stage, low risk breast cancer
Conference call to be held today at 10:00 am Eastern Time
CAESAREA, Israel, Aug. 20, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure," "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today reported financial results as of and for the six months ended June 30, 2024.
Significant Near and Short Term Value Enhancing Catalysts
U.S. Food and Drug Administration ("FDA") Medical Device Advisory Committee expected Q4 2024. The purpose of the meeting is to obtain independent expert advice on scientific, technical, and policy matters related to the Company's De Novo Marketing Clearance Request for a minimally invasive alternative treatment for women diagnosed with early-stage, low risk breast cancer.
The FDA will review and evaluate the recommendation of the Medical Device Advisory Committee and is expected to have a final decision regarding marketing clearance of ProSense® in early-stage, low risk breast cancer by early 2025.
Data from interim results of the Company's ICESECRET, a prospective, multicenter, single-arm clinical trial of ProSense® in the treatment of kidney cancer, is expected to be presented by December 2024.
The Company's partner in Japan, Terumo Corporation, is expected to file for regulatory approval of ProSense® for early-stage low risk breast cancer with endocrine therapy in Japan in the first quarter of 2025, with the aim of receiving clearance and making the Company's cryoablation system more commercially available to physicians and patients alike in Japan.
With 15 ongoing independent studies being performed globally, the Company expects additional third-party data on ProSense® will be published in medical journals and presented at prestigious medical conferences.
"We have achieved all of our primary objectives for the first half of 2024, and we are now in the process of preparing for the FDA Medical Device Advisory Committee, which we expect to be scheduled for Q4," stated IceCure Medical's CEO, Eyal Shamir. "The data from the ICE3 study has been overwhelmingly positive, and with a reported 100% patient and physician satisfaction rate, our goal is to highlight these results and leverage the expert testimony to secure a favorable recommendation from the committee to treat women diagnosed with early-stage, low risk breast cancer, and to ensure we maintain the forward momentum through year-end and into 2025 upon potential clearance from the FDA.
"The U.S. is the largest healthcare market in the world, and as a patient-centric company, we believe it's critically important to offer patients a safe and proven non-surgical procedure with a system that is cleared in 15 countries, including in the U.S. Moreover, we strongly believe that our first half 2024 system and probe sales growth of 20%, notwithstanding the revenue recognition from Terumo, is primarily due to women and their physicians making a conscious choice to use ProSense® and avoid a surgical procedure because it's a win-win scenario for patient, physician, health provider, and payor."
Second Quarter and Recent ProSense® Efficacy & Safety Data Reported by Independent Researchers
ProSense® Destroyed 100% of Breast Cancer Tumors in Independent Study of Patients Who Chose Cryoablation Instead of Surgery: The aim of the study titled "Acceptance and results of cryoablation for the treatment of early breast cancer in non-surgical patients" published in the British Journal of Radiology was to evaluate the acceptance of percutaneous cryoablation treatment by patients with early-stage breast cancer who choose not to have surgery. Of the 45 patients offered cryoablation with ProSense®, 43 patients, or 95.6% accepted. 36 of these, representing 39 malignant tumors (median size 24mm), proceeded to undergo cryoablation. The median age of patients treated with cryoablation was 87, with a range of 60-96. After a median follow-up of 16 months, the complete ablation rate in luminal A and B breast cancer with tumors = 25mm was 100%. No major complications were seen.
Zero (0%) Breast Cancer Local Recurrence 5 Years Following Treatment in Japan with ProSense®: Data from a study performed in Japan was published in an article titled "Percutaneous ultrasound-guided cryoablation for early-stage primary breast cancer: a follow-up study in Japan," in the journal Breast Cancer. Eighteen early-stage breast cancer patients, with a mean age of 59.0 [±9.0 years], with a mean tumor size of 9.8 ±2.3 millimeters, who underwent treatment with ProSense® were followed for a mean of 44.3 months. No patients had local recurrence or distant metastasis in the 5-year follow-up. No serious adverse events were reported. Cosmetic outcomes were excellent and the overall patient satisfaction level and patient quality of life improved post-cryoablation.
European Study Provided More Evidence Supporting ProSense® Treatment for Metastatic and Recurrent Breast Cancer: Data published in the highly influential peer-reviewed journal, Cancers, concluded cryoablation with ProSense® is a safe, local treatment for breast cancer with a low complication rate, high complete ablation rate and satisfactory overall survival (OS), progression free survival (PFS) and local tumor control. The recurrence rate was 8.9% in a population of 45 patients who had previously received various therapies before cryoablation including surgery, radiation therapy, or chemotherapy with tumor sizes of up to 4 centimeters in diameter. Of those patients, 11 had recurrent tumors and 21 had metastatic disease. This higher-risk population contrasts with the early-stage breast cancer patient subjects in IceCure's U.S. ICE3 trial. The European study titled "CT-Guided Percutaneous Cryoablation of Breast Cancer: A Single-Center Experience" was conducted at Goethe University in Germany.
99.74% Recurrence Free Rate for Women with Breast Cancer Treated with ProSense® in Japan: From April 2014 through August 2020, 389 breast cancer patients with tumor lesions of less than 15 millimeters in diameter were treated with ProSense®. The ipsilateral breast tumor recurrence rate (IBTR) was 0.26%, resulting in a 99.74% recurrence free rate. These data were presented at 32nd Annual Meeting of the Japanese Breast Cancer Society, where the demand for minimally invasive breast cancer treatment was an overarching theme.
Financial Results for the Six Months Ended June 30, 2024
Sales of ProSense® systems and disposable probes for the six months ended June 30, 2024 grew by 20% to $1,654,000 compared to $1,373,000 for the six months ended June 30, 2023. The growth was primarily attributable to sales in Europe, the U.S., Japan and other territories in Asia which were partially offset by a decrease in sales in China. Total Revenue for the six months ended June 30, 2024, grew to $1,754,000 from $1,647,000 for the six months ended June 30, 2023 due to an increase in the sale of ProSense® systems and disposables, which was partially offset by a decrease in revenue recognition and other services in Japan of $100,000 and $274,000 in the first six months of 2024 and 2023, respectively.
Gross profit for the six months ended June 30, 2024 grew to $799,000 from $754,000 for the six months ended June 30, 2023. Gross margin for the six months ended June 30, 2024 and for the six months ended June 30, 2023 was 46%. Non-GAAP gross profit for the six months ended June 30, 2024 increased to $699,000 from $480,000 for the six months ended June 30, 2023, an increase of $219,000 or 46%. Non-GAAP gross margin for the six months ended June 30, 2024 grew to 42% from 35% for the six months ended June 30, 2023. The increase in non-GAAP gross profit and non-GAAP gross margin, which exclude revenue from the exclusive distribution agreements and other services in Japan, was attributable to the increase of 20% in revenue from sales of ProSense® systems. Non-GAAP gross profit and non-GAAP gross margin are financial measures that may be defined as "non-GAAP financial measures" by the U.S. Securities and Exchange Commission ("SEC"). For a reconciliation of these non-GAAP financial measures to the nearest comparable GAAP measure, see Appendix A to this press release.
Research and development expenses for the six months ended June 30, 2024 were $3,536,000 compared to $4,190,000 for the six months ended June 30, 2023. The decrease was primarily due to a reduction in development expenses for the XSense™ System, which received FDA clearance in June 2024, and a decrease in clinical and regulatory costs as the Company concluded the ICE3 study in March 2024 and submitted the application to the FDA in April 2024. Sales and marketing expenses for the six months ended June 30, 2024 were $2,296,000 compared to $2,253,000 million for the six months ended June 30, 2023. General and administrative expenses for the six months ended June 30, 2024, narrowed to $1,845,000 from $2,349,000 for the six months ended June 30, 2023.
Total operating expenses for the six months ended June 30, 2024 decreased to $7,677,000 from $8,792,000 for the six months ended June 30, 2023. The decrease in operating expenses was attributable to reductions in research and development, and general and administrative expenses, due to the Company's initiative to reduce non-critical operating expenses which were partially offset by an increase in sales and marketing expenses.
Net loss for the six months ended June 30, 2024 narrowed to $6,690,000 million, or $0.14 per share compared to a net loss of $7,657,000 million, or $0.17 per share, for the same period last year.
As of June 30, 2024, the Company had cash and cash equivalents, including short-term deposits, of approximately $10.5 million, compared to $11 million as of December 31, 2023. As of July 31, 2024, the Company had cash and cash equivalents of approximately $10.3 million. During the first half of 2024, the Company raised $4.7 million in net proceeds from the sale of 3,787,976 ordinary shares under its at-the-market ("ATM") offering facility.
Use of Non-U.S. GAAP Measures
In addition to disclosing financial results prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP), this press release contains certain financial measures which may be defined as "non-GAAP financial measures" by the SEC. The Company defines non-GAAP gross profit as gross profit less revenue from exclusive distribution agreements and other services. The Company has provided non-GAAP gross profit in this press release because it is a key measure used by management and the board of directors as an indication of our gross profit from sales of our systems and disposables and management believes that it is useful to investors' understanding and assessment of the Company's gross profit without the impact of revenue recorded from the Company's exclusive distribution agreements and other services. The Company has provided a reconciliation below of non-GAAP gross profit and non-GAAP gross margin to the most directly comparable financial measure calculated and presented in accordance with U.S. GAAP. The non-GAAP financial measures disclosed by the Company should not be considered in isolation or as a substitute for, or superior to, financial measures calculated in accordance with U.S. GAAP and the financial results calculated in accordance with U.S. GAAP and reconciliations to those financial results should be carefully evaluated.
Conference call & webcast info:
Tuesday, August 20, 2024, at 10:00 am EDT
US: 1-888-407-2553
Israel/International: +972-3-918-0696
A live webcast will be available at: https://Veidan.activetrail.biz/IcecureQ2-2024
A recording of the webcast will be available at: ir.icecure-medical.com
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.
RedHill Announces Positive Obesity and Diabetes Results with Opaganib
https://finance.yahoo.com/news/redhill-announces-positive-obesity-diabetes-110000454.html
The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034[1] – largely driven by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk's Ozempic® and Wegovy® and Eli Lilly's Trulicity® and Mounjaro® and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim's Jardiance®
Positive results from multiple in vivo studies show the impact of sphingosine kinase-2 (SPHK2) inhibition in various models of metabolic disease, supporting the potential of opaganib therapy for diabetes and obesity-related disorders
With multiple U.S. government collaborations ongoing, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection
TEL-AVIV, Israel and RALEIGH, N.C., Aug. 19, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive results from multiple in vivo studies, undertaken by RedHill's partner, Apogee Biotechnology Corporation, showing the impact of opaganib[2] on weight gain and glucose tolerance in a high fat diet (HFD) model, supporting the potential clinical use of opaganib for the prevention and therapy of Type 2 diabetes and other obesity-related disorders.
"Sphingolipid metabolism is implicated in insulin resistance, ß-cell disruption, adipocyte function, inflammation and immune regulation, vascular complications and energy metabolism – all significant components of obesity, diabetes and their associated complications," said Charles D. Smith, Ph.D. Founder and CEO of Apogee Biotechnology Corporation. "Opaganib's ability to modulate multiple signaling pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells provides a strong rationale for evaluation of opaganib in obesity-related disorders."
The studies were designed to examine some of the most fundamental aspects of diabetes and obesity-related disease. The encouraging outcomes showed the benefit of opaganib therapy in suppression of HFD-induced body weight gain, loss of glucose tolerance and fat deposition. Additionally, opaganib treatment reduced weight gain and restored glucose tolerance in an already obese HFD model, suggesting its potential for treating, not just preventing, obesity-related disorders.
"Sphingolipid metabolism is a key pathway in many diseases, including obesity, but has not been adequately examined as a therapeutic target for human therapy," said Dr. Mark Levitt, Chief Scientific Officer at RedHill. "Opaganib, which acts as a sphingosine competitor, is the first clinical drug to target three key enzymes in this pathway."
The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034 – largely driven by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk's Ozempic and Wegovy (semaglutide) and Eli Lilly's Trulicity (dulaglutide) and Mounjaro (tirzepatide) and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim's Jardiance (Empagliflozin).
RedHill Biopharma Announces Plan to Implement ADS Ratio Change
https://finance.yahoo.com/news/redhill-biopharma-announces-plan-implement-110000303.html
TEL AVIV, Israel and RALEIGH, N.C., Aug. 16, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it plans to implement a ratio change of the Company's American Depositary Shares (ADSs) to its non-traded ordinary shares from the current ratio of one (1) ADS representing four hundred (400) ordinary shares to a new ratio of one (1) ADS representing ten thousand (10,000) ordinary shares. The anticipated first date of the ratio change is on or about August 20, 2024, and the Company's ADSs will continue to be traded on the Nasdaq Capital Market ("Nasdaq") under the symbol "RDHL" with a new CUSIP Number 757468301.
For ADS holders, the ratio change will have the same effect as a one-for-25 reverse ADS split. No new ADSs will be issued in connection with the change in the ADS ratio. ADS holders will not be required to take any action and, on the effective date, the Bank of New York Mellon, the depositary bank for RedHill's ADS program, will arrange for the exchange of every twenty-five (25) existing ADSs held for one (1) new ADS.
No fractional new ADSs will be issued in connection with the change in the ADS ratio. Instead, fractional entitlements to new ADSs will be aggregated, and the depositary bank will attempt to sell them with the net cash proceeds from the sale of the fractional ADS entitlements to be distributed to the applicable ADS holders by the depositary bank.
On March 14, 2024, the Company reported that it had received notification from the Nasdaq Capital Market, LLC that it did not comply with the minimum bid price requirements set forth in Nasdaq Listing Rule 5450(a)(2) for continued listing on Nasdaq. The Company anticipates that after the ratio change, the price of its ADSs will increase proportionally and meet the Nasdaq minimum bid price requirement, however there can be no assurance that such an increase will occur.
BioLineRx Ltd. (BLRX) Q2 2024 Earnings Call Transcript
Aug. 15, 2024 3:03 PM ETBioLineRx Ltd. (BLRX) Stock
Q2: 2024-08-15 Earnings Summary
EPS of $0.00 beats by $0.14 | Revenue of $5.39M beats by $2.45M
BioLineRx Ltd. (NASDAQ:BLRX) Q2 2024 Earnings Conference Call August 15, 2024 8:30 AM ET
Company Participants
John Lacey - Head of IR and Corporate Communications
Phil Serlin - CEO
Holly May - President of BioLineRx USA
Mali Zeevi - CFO
Ella Sorani - Chief Development Officer
Conference Call Participants
John Vandermosten - Zacks
Operator
Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2024 Financial Results Conference Call. [Operator Instructions]. Following management's formal presentation, instructions will be given for the question-and-answer session.
I would now like to hand the call over to John Lacey, Head of Investor Relations, and Corporate Communications. John, please go ahead.
John Lacey
Thank you, operator. Welcome, everyone. Thank you for joining us on our second quarter 2024 results conference call. Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K.
I'd like to remind you that certain statements we make during the call will be forward-looking. Because such statements deal with future events, and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks, and uncertainties, please review our annual report on Form 20-F and our quarterly reports on Form 6-K that are filed with the U.S. Securities and Exchange Commission. On the call today, we will have Phil Serlin, Chief Executive Officer of BioLineRx; Holly May, President of BioLineRx USA; and Mali Zeevi, our Chief Financial Officer. In addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A.
At this time, it is now my pleasure to turn the call over to Phil.
Phil Serlin
Thank you, John, and good morning, everyone, and thank you for joining us on today's call.
Following our strong second quarter 2024 performance and the encouraging progress of APHEXDA to launch to date. I wanted to highlight that today's BioLineRx is a fully integrated leader in stem cell mobilization with promising label expand opportunities. This is a stark change from last year, and we are well positioned to deliver value to all of our stakeholders. I will begin with a brief update on the important progress that we are making on our APHEXDA launch then turn the call over to Holly who'll go into our commercialization and life cycle management progress in more detail.
Mali will review our financial results, and then I will give a brief summary of our upcoming milestones. We will then open up all for your questions. Let me begin with an effect to commercialization update. Last quarter, we set an important goal. We said that among our targeted top 80 transplant centers, by the end of the second quarter, we would secure formulary placement at institutions managing 35% of stem cell transplant procedures.
And I'm happy to say that we surpassed this goal by June 30 with formulary placement at institutions managing 37% of transplant procedures. We continue to make steady progress on this most important launch metric and remain on track to achieve our year-end target of 60%.
Additionally, last quarter, we achieved formulary status at two of the largest transplant centers in the U.S., and we also doubled the number of centers ordering product. We are pleased with this continued positive momentum in only the second full quarter of our commercialization program. Each week, we learn about patients who have failed to collect enough stem cells on other mobilization agents putting their path to transplant at risk.
These patients were then given APHEXDA and they achieved their stem cell mobilization goals, many in a single apheresis session. Transplant centers are seeing the tremendous efficacy that APHEXDA can provide in this new era for multiple myeloma patients, where patients more often are older and increasingly received quad induction therapy which can increase mobilization risk.
In July, the FDA granted approval of an important quad therapy approach for transplant eligible, newly diagnosed multiple myeloma patients, including daratumumab and lenalidomide which can negatively impact stem cell yields. The approval was based on the tremendous efficacy results seen in the PERSEUS trial, which compared the quad therapy to the leading triple therapy. The quad therapy lowered the risk of disease progression or death by 60%.
Physicians have been treating patients with quad therapies prior to this approval. However, we believe that the data from this trial and the subsequent FDA approval will accelerate the process of quad therapy becoming the new standard of care, which, while beneficial to patients has the potential to further increase the need for APHEXDA. Our team is excited to be introducing a new standard of care for the mobilization of stem cells for multiple myeloma in this new era of care for patients.
At this point, I'd like to turn the call over to Holly May, President of BioLineRx U.S., to discuss our commercialization efforts and some of our life cycle management initiatives. Holly, please go ahead.
Holly May
Thank you, Phil.
Last quarter, I discussed APHEXDA benefits on center efficiency and economics, and in conversations with transplant center key decision-makers, including physicians, pharmacists and apheresis unit Managing Directors. These two factors continue to be a significant determinant in transplant center formulary adoption.
We launched effect into a mobilization agent market that included generic plerixafor which had just entered generic status a few months before our approval. At the same time, transplant centers were realizing the impact that new induction therapy approaches have on stem cell collection yields.
These factors quite naturally created many questions for centers, centers that have, for many years, had long-standing protocols. It is within this changing landscape that institutions have also come to understand effective innovative benefits for patients and are actively studying how our product can benefit their center and members of our field force are supporting them in this effort with our efficiency modeling tools.
Additionally, we are publishing important health economic data and continues to work on additional research. Our health economic presentations in April at the American Society for Apheresis Annual Meeting and at the International Society for Pharmacoeconomics and Outcomes Research demonstrated the economic advantages for centers using G-CSF plus APHEXDA over G-CSF alone or G-CSF plus plerixafor. Given the efficacy, efficiency and economic benefits that APHEXDA provides, we believe that key decision-makers will continue to move toward our best-in-class mobilizer.
Let me transition now to our life cycle management efforts. Our vision is to maximize the potential of APHEXDA in its current indication and to expand into key areas with high unmet need. There is significant interest by independent investigators to evaluate APHEXDA across a number of areas associated with myeloma, including mobilization studies in patients treated with quad therapies or for post-CAR T cytopenia management.
We are also actively speaking with physician researchers across a number of additional disease states that have high unmet need in the area of stem cell mobilization. One critical area that continues to make progress is evaluating APHEXDA's stem cell mobilization potential in patients with sickle cell disease undergoing gene therapy.
This type of gene therapy is an area where I have significant experience based on my prior roles. The two currently approved gene therapies for sickle cell disease require significant quantities of stem cells to produce the therapies. And in speaking with leaders in the field using a mobilization agent that could speed the collection process would be a great advantage for patients. Our two ongoing sickle cell disease Phase 1 investigator-initiated studies with Washington University in St. Louis and St.
Jude's Children's Research Hospital in Memphis, were designed by significant key opinion leaders in this research area. We anticipate early data from the Washington collaboration in the second half of this year and the first patient dosed in the St. Jude study in September. Overall, in the next 12 months, we anticipate several independent investigators to initiate studies that will provide BioLine with critical data and insights to aid our ongoing life cycle management efforts.
Now let me turn the call over to Mali to provide a financial update.
Mali Zeevi
Thank you, Holly.
As is our practice, I will only go over the most significant items in our financial statements. Revenues, cost of revenues research and development expenses, sales and marketing expenses, net profit and cash. I invite you to review the filings we made this morning, which contain our financials and press release.
Total revenue for the three months ended June 30, 2024, was $5.4 million. We did not record any revenue during the second quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million as well as $1.8 million of net revenue from product sales of APHEXDA in the U.S. Cost of revenue for the three months ended June 30, 2024, was $0.9 million. We did not record any cost of revenue during the second quarter of 2023.
Cost of revenue for the quarter primarily reflects the amortization of intangible assets royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales. Research and development expenses for the three months ended June 30, 2024, were $2.2 million compared to $3 million for the same period in 2023.
The decrease resulted primarily from lower expenses related to motixafortide activities the termination of the development of AGI-134 and the decrease in share-based compensation. Sales and marketing expenses for the three months ended June 30, 2024, were $6.4 million compared to $5.6 million for the same period in 2023.
The increase resulted primarily from the ramp-up in head count costs associated with fully hired field team. Net income for the three months ended June 30, 2024, was $0.5 million compared to a net loss of $18.5 million for the same period in 2023. The net income for the 2024 period included $7.8 million in nonoperating income compared to nonoperating expenses of $7.7 million for the same period in 2023, both mainly related to the noncash revaluation of warrants.
As of June 30, 2024, the company had cash, cash equivalents and short-term bank deposits of $40.1 million. The company anticipates that this amount will be sufficient to fund operations as currently planned into 2025.
And with that, I'll turn the call over to Phil.
Phil Serlin
Thank you, Mali.
In closing, as is our custom, I would like to take a few moments to summarize our upcoming milestones. We anticipate first patient dosed in the St. Jude sickle cell disease gene therapy Phase 1 trial in September. The Phase 1 clinical trial is an open-label multicenter study evaluating the safety, tolerability and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ hematopoietic stem cells in 12 patients, aged 18 and older with sickle cell disease.
We anticipate the initiation of the bridging study by collaboration partner, Gloria Biosciences to support approval of APHEXDA in stem cell mobilization for multiple myeloma in China in the second half of this year. Also in the second half of this year, as Holly mentioned, we anticipate a presentation on early data from the wash use sickle cell disease gene therapy Phase 1 trial, evaluating motixafortide as a monotherapy and in combination with natalizumab for stem cell mobilization.
Additionally, working with Gloria Bio, we completed the study design of the Phase 2b combination study evaluating motixafortide in first-line pancreatic cancer. We anticipate that Gloria will submit the study designed for regulatory review in 2024 with the study initiating in 2025.
Finally, we continue recruitment in the CheMo4METPANC IIb randomized clinical trial in first-line metastatic pancreatic cancer sponsored by Columbia University and in partnership with Regeneron. We anticipate that this trial, which had very encouraging pilot phase data published at ASCO this quarter will be fully enrolled by 2027.
With that, we have now concluded the formal part of our presentation. Operator, we will now open the call up for questions.
Question-and-Answer Session
Operator
[Operator Instructions] The first question is from John Vandermosten of Zacks. Please go ahead.
John Vandermosten
Great. Thank you. So the summer is usually known to have kind of negative seasonal effects for both, I guess, therapy use and with hospital staff, especially in academic settings. And I'm wondering if you could comment on how you expect seasonally the effort to go with sales of APHEXDA. Do you anticipate a strong pickup activity in September? And was this summer, I guess it's not over yet, but I guess was this summer as you had expected?
Phil Serlin
Yes. So John, good morning, and thanks for the question and joining the call. So I'll turn it over to Holly in a moment. But our results are through June 30. So we're talking now about the second quarter, which is really the spring. I would like to, again, mention that we doubled our sales in Q2 from Q1. And so I'm not sure the results at this point really reflect any kind of slowdown -- seasonal slowdown in the summer. We're looking -- things are looking very, very good at the moment. I'll let Holly expand on that, if she'd like.
Holly May
Yes. Thanks, Phil, and good morning John. So we have actually analyzed some of the seasonality on a month-to-month basis. because this is indicated for multiple myeloma, and it's very dependent on patients needing to get timely transplants. We don't necessarily see those same kind of seasonality effects with a product like APHEXDA as you may with others. That's a very general answer, but that is not something that we are terribly concerned about and have huge downturns built into any kind of forecasting for that reason. Does that answer your question?
John Vandermosten
Yes, it does. And how would you characterize the reorder rate? It seems like based on kind of a top-down view that it's fairly good. Would you characterize it that way as well?
Phil Serlin
Holly, you want to take that?
Holly May
Yes, I would love to. So yes, so once -- I think we've spoken about this before. Once a product is on formulary, that's the biggest hurdle to begin utilization -- adoption and utilization and an uptake in sales. And so our field teams are continuing to do both things to onboard institutions that have approved us for formulary through their P&T. So that is a significant part of future growth as well as then working on institutions where we already have formulary acceptance and continuing to do selling efforts in those hospitals to increase the quantities where we are on formulary.
So the team very early on, the field teams very early on were singularly focused on assuring the readiness of P&T committees to put us on formulary. That work continues, but now we are also looking at selling efforts in those institutions that have us on formulary to increase there. So we see revenues from both sources, new accounts and existing accounts as we move throughout the year.
John Vandermosten
Okay. And final question on sickle cell and gene therapy. I guess I was surprised to see two studies in the same gene therapy indication. And I guess that's because -- maybe you can tell me why that is. And then are there any other gene therapy indications that would also be kind of the next place to go for using motixafortide to collect the proper number of cells?
Phil Serlin
Yes. So let me ask Ella, maybe you can talk about the differences between the two studies a little bit.
Ella Sorani
Yes. I'm sorry, but -- the design of the St. Jude study is not -- I don't think that we have disclosed it yet. The design -- there is a difference between the two studies in terms of ...
Phil Serlin
Yes. I guess you're right. Yes, perhaps you can't disclose that yet. I mean are there different -- they're -- I'm wondering if -- I just don't remember whether we've disclosed that. You're sure we haven't disclosed it? Yes. So John, I'm sorry about that.
There are differences in the studies based on whether there are single administrations or multiple administrations and the size of the studies -- but I don't think, like as Ellen said, I don't think that we've spoken about the design yet. There are publication and embargoes and those kind of things that we can't really discuss it at this point. I apologize.
John Vandermosten
Okay. And well -- and then I guess are there any other kind of gene therapy indications that would be equally addressed from sponsors to use motixafortide to collect enough cells? Because I assume that's why the sickle cell was chosen compared to others, they just need more cells.
Phil Serlin
Yes. Well, it's more complicated than that. I mean, I'll turn it over to Holly, but I'll just say one of the reasons why mobilization is so difficult in sickle cell patients is because the underlying mobilization agent G-CSF is contraindicated in sickle cell patients. And therefore, they can only get what you'd call in air quotes, a booster, plerixafor or like APHEXDA. So they can't get the underlying G-CSF, which is given to patients like multiple myeloma before they're given booster agent, so to speak.
So that's one of the main reasons why this is an area that is extreme that has a clear unmet medical need in mobilization. But Holly, if you'd like to expand on that, please feel free.
Holly May
Yes, I'm happy to talk about that a little bit. So there are different types of gene therapy, some like AV therapy that do not require hematopoietic stem cells and others, like the sickle cell approved therapies right now by Bluebird and Vertex that do require stem cells in order to complete the gene therapy.
And so certainly, sickle cell based on the things that Phil just said is the ideal place to begin using a product like APHEXDA for the mobilization of stem cells to complete that type of gene therapy. But we do see that there could be other types of gene therapies that do require CD34 stem cells, which could very easily benefit from APHEXDA in the future. But currently, we are focused on generating the data in sickle cell because of the high unmet.
John Vandermosten
Understood. Thank you, Holly.
Holly May
Yes. Thanks John.
Operator
[Operator Instructions] The next question is from John Vandermosten of Zacks. Please go ahead.
John Vandermosten
Great. Thanks for allowing me a follow-up. Have there been any inquiries from investigators for use that APHEXDA outside of multiple myeloma, expanding more into some other leukemias?
Phil Serlin
As Holly mentioned, and I think I'll let her expand on it a little bit. We have a number of requests from investigators to perform investigate initiated studies in potentially different indications, et cetera? Holly, do you maybe want to expand on that a little bit?
Holly May
Yes. I guess I'm looking for some guidance here as sort of what I can and can't say. Some we are in the process of these ISSs. We are in the process of signing for what I would call kind of indication enhancing data and other investigators are very interested in other areas of study and investigation where mobilization of stem cells is required.
So I think the easiest way to say this is we have a very active IFS program that we have launched here since that we have initiated since launch, and we continue to review all of those proposals, but there does seem to be a lot of interest in motixafortide to be studied in areas to improve on things like multiple myeloma and then in other indications as well.
John Vandermosten
Okay, great. Thank you.
Holly May
Thanks John.
Operator
There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1 (888) 295-2634. In Israel, please call 03-925-5904. Internationally, please call 972-3-955-904.
Mr. Serlin, would you like to make your concluding statement?
Phil Serlin
Yes, I would. Thank you, operator. In closing, we are progressing through 2024 with significant momentum both with the ongoing commercial ramp-up of APHEXDA as well as the advancement of our development programs in sickle cell disease and pancreatic cancer. I'm excited to what we are poised to accomplish over the remainder of the year and next.
Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in November. Be safe, and have a good day.
Operator
This concludes BioLineRx second quarter 2024 conference call. Thank you for your participation. You may now go ahead and disconnect.
MediWound Announces U.S. Food and Drug Administration Approval of NexoBrid® for the Treatment of Pediatric Patients with Severe Thermal Burns
https://finance.yahoo.com/news/mediwound-announces-u-food-drug-201500706.html
Approval Helps Solidify NexoBrid’s Position in the U.S. as a Safe and Effective Non-Surgical Burn Treatment for All Ages
YAVNE, Israel, Aug. 15, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. With this FDA approval, NexoBrid is now authorized for use in the U.S. for all age groups, aligning with its approvals in the European Union and Japan.
“Today's announcement marks a significant milestone in our mission to improve burn care with NexoBrid,” said Ofer Gonen, Chief Executive Officer of MediWound. “Pediatric burn victims represent over 30% of the total burn population, and the current surgical standard of care can be extremely traumatic for both patients and their families. Since NexoBrid's initial approval, we have been dedicated to expanding its use to children, reflecting our long-term commitment to revolutionizing burn care.”
The submission was supported by the results of a global Phase III clinical trial, Children Innovation Debridement Study (CIDS), which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase III and Phase II studies conducted during the clinical development of NexoBrid. Of note, the CIDS trial was funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services.
Close to no revenue and rs coming soon,
small wonder.
BioLineRx Reports Second Quarter 2024 Financial Results and Recent Corporate and Portfolio Updates
https://finance.yahoo.com/news/biolinerx-reports-second-quarter-2024-110000860.html
- Secured APHEXDA® formulary placement among top 80 transplant centers representing ~37% of stem cell transplant procedures performed, surpassing stated goal for quarter; on-track to reach goal of ~60% by end of Q4 -
- Doubled the number of centers ordering APHEXDA during the second quarter -
- Entered into clinical trial agreement with St. Jude Children's Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease -
- Management to host conference call today, August 15, at 8:30 am EDT -
TEL AVIV, Israel, Aug. 15, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the second quarter ended June 30, 2024, and provided recent corporate and portfolio updates.
"We continue to demonstrate positive commercial launch momentum with APHEXDA, our best-in-class stem cell mobilization agent," said Philip Serlin, Chief Executive Officer of BioLineRx. "Importantly, among our targeted top 80 transplant centers, we've secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, surpassing our stated goal. Additionally, we doubled the number of transplant centers ordering APHEXDA during the second quarter, which is a strong leading indicator and, we believe, reflects centers' growing recognition of the value that APHEXDA offers relative to other mobilization agents. Our goal is to achieve formulary placement at institutions representing approximately 60% of procedures by the end of year, which will support continued revenue growth and ease burdens on patients, caregivers, and transplant centers.
"Our vision is to maximize the potential of APHEXDA by expanding into key areas with high unmet need. To that end, we announced our second clinical trial collaboration, with St. Jude Children's Research Hospital, evaluating APHEXDA for stem cell mobilization in patients with sickle cell disease (SCD) seeking gene therapy. This new collaboration complements the ongoing SCD stem cell mobilization Phase 1 trial at Washington University in St. Louis (Wash U.). APHEXDA has the potential to support the collection of the immense amount of stem cells needed for these complex gene therapies in a more predictable and condensed timeline for patients. The companies launching these new gene therapies for SCD report continued expansion of authorized treatment centers and increased numbers of patients initiating cell collection. We look forward to seeing early data from the Wash U. Phase 1 trial later this year."
APHEXDA Launch Updates
Among top 80 transplant centers, secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, exceeding the company's stated goal for the quarter; on track to achieve ~60% by year-end 2024
Saw double the number of centers ordering APHEXDA during the second quarter as compared to the first quarter, which contributed to quarter-over-quarter net revenue growth of 100%
Clinical Portfolio Updates
Motixafortide
Multiple Myeloma
Presented a poster at the American Society for Apheresis (ASFA) 2024 Annual Meeting on April 17, 2024, demonstrating that transplant centers (averaging, for example, 20 transplants per month), when switching to G-CSF plus APHEXDA, could increase capacity by 52.0 patient days per month versus G-CSF alone, or by 12.3 patient days per month versus G-CSF in combination with plerixafor
Presented a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on April 6, 2024, showing that even with APHEXDA's higher drug acquisition cost compared to other mobilization regimens, specifically G-CSF alone or G-CSF plus generic plerixafor, the combination of G-CSF plus APHEXDA may confer a similar or better overall financial impact while providing centers and patients with an improved mobilization experience
Collaboration partner Gloria Biosciences' stem cell mobilization bridging study IND was filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate initiation of pivotal clinical trial in 2H 2024
Sickle Cell Disease (SCD) & Gene Therapy
Entered into clinical trial agreement with St. Jude Children's Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease. The Phase 1 clinical trial is an open-label, multi-center study evaluating the safety, tolerability, and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ HSCs in 12 patients (aged 18 and older) with SCD. Anticipate first patient dosed in September 2024 and initial data in 2025
Reported continuing enrollment of patients into a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial, in collaboration with Washington University School of Medicine in St. Louis, has been expanded from five to 10 patients. Anticipate initial data in 2H 2024
Pancreatic Ductal Adenocarcinoma (mPDAC)
Presented positive biopsy data from the completed pilot phase of the ongoing CheMo4METPANC Phase 2b clinical trial collaboration with Columbia University at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting held on June 1, 2024 in Chicago, IL. New analyses of paired pre- and on-treatment biopsy samples demonstrated a statistically significant increase in CD8+ T-cell density in tumors from all 11 patients treated with the combination therapy approach (P=0.007). Enrollment in the randomized trial targeting 108 patients continues with full enrollment anticipated in 2027
Completed design of Phase 2b randomized clinical trial in China with collaboration partner Gloria Biosciences intended to assess motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer. Anticipate clinical trial initiation in 2025
Second Quarter 2024 Financial Results
Total revenue for the three months ended June 30, 2024 was $5.4 million. The Company did not record any revenue during the second quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million, as well as $1.8 million of net revenue from product sales of APHEXDA in the U.S.
Cost of revenue for the three months ended June 30, 2024 was $0.9 million. The Company did not record any cost of revenue during the second quarter of 2023. Cost of revenue for the quarter primarily reflects the amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S., and cost of goods sold on product sales
Research and development expenses for the three months ended June 30, 2024 were $2.2 million, compared to $3.0 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide New Drug Application (NDA) supporting activities, termination of the development of AGI-134 and a decrease in share-based compensation
Sales and marketing expenses for the three months ended June 30, 2024 were $6.4 million, compared to $5.6 million for the same period in 2023. The increase resulted primarily from the ramp-up in headcount costs associated with a fully hired field team
General and administrative expenses for the three months ended June 30, 2024 were $1.6 million, compared to $1.3 million for the same period in 2023. The increase resulted primarily from an increase in legal and certain other expenses
Net income for the three months ended June 30, 2024 was $0.5 million, compared to net loss of $18.5 million for the same period in 2023. The net income for the 2024 period included $7.8 million in non-operating income, compared to non-operating expenses of $7.7 million for the same period in 2023, both primarily related to the non-cash revaluation of warrants
As of June 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $40.1 million. The Company anticipates that this amount will be sufficient to fund operations, as currently planned, into 2025
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until August 19, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
biolinerx Q2 Earnings Preview
Aug. 14, 2024 11:17 AM ET
BioLineRx Ltd. (BLRX) Stock
By: Pranav Ghumatkar, SA News Editor
biolinerx (NASDAQ:BLRX) is scheduled to announce Q2 earnings results on Thursday, August 15th, before market open.
The consensus EPS Estimate is -$0.14 and the consensus Revenue Estimate is $2.94M.
Over the last 2 years, BLRX has beaten EPS estimates 25% of the time and has beaten revenue estimates 25% of the time.
IceCure's ProSense® Destroyed 100% of Breast Cancer Tumors in Independent Study of Patients Who Chose Cryoablation Instead of Surgery
https://finance.yahoo.com/news/icecures-prosense-destroyed-100-breast-123000650.html
After a median follow-up of 16 months, the complete ablation rate in Luminal A and B breast cancer tumors ≤ 25mm was 100%
Study concluded that most non-surgical patients with early-stage breast cancer accepted cryoablation when the treatment was offered and that cryoablation is a safe, effective alternative to surgery and well-tolerated as an out-patient procedure
CAESAREA, Israel, Aug. 14, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the publication of an independent study titled "Acceptance and results of cryoablation for the treatment of early breast cancer in non-surgical patients" in the British Journal of Radiology, a publication of the British Institute of Radiology. The single-site study, led by Lucia L. Garna Lopez, PhD, was conducted by researchers in the radiology, oncology, and surgery departments at Hospital Lucus Augusti in Lugo, Spain.
The aim of the study was to evaluate the acceptance of percutaneous cryoablation treatment by patients with early-stage breast cancer who choose not to have surgery. Of the 45 patients offered cryoablation with ProSense®, 43 patients, or 95.6% accepted. 36 of these, representing 39 malignant tumors (median size 24mm), proceeded to undergo cryoablation.
"This study is a good case in point that when women who elect not to have surgery, or are not eligible for surgery, are given the option, they overwhelmingly choose cryoablation to treat their breast cancer," stated IceCure CEO Eyal Shamir. "In addition to providing excellent data on the safety and efficacy of ProSense® in patients who chose not undergo surgery, the study's authors also point to the correlation between a larger aging population, increased risk of breast cancer with age, and the fact that most patients who elect not to have surgery or are not eligible are elderly patients. These factors, we believe, point to increasing demand for ProSense® when it is presented as an option."
The median age of patients treated with cryoablation was 87, with a range of 60-96. After a median follow-up of 16 months, the complete ablation rate in luminal breast cancer with tumors ≤ 25mm was 100%. No major complications were seen.
The study investigators concluded that most non-surgical patients with early-stage breast cancer accepted cryoablation when the treatment was offered and that cryoablation is safe, effective, and well-tolerated as an outpatient procedure. The published article went on to state that outcomes suggest cryoablation could be an alternative to surgery for the management of breast cancer in this group of patients and pointed to financial, physical, and cosmetic benefits.
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.
Kamada Reports Strong Second Quarter and First Half 2024 Financial Results with Year-Over-Year 6-Month Top-Line Growth of 18% and a 68% Increase in Profitability
https://finance.yahoo.com/news/kamada-reports-strong-second-quarter-110000469.html
Revenues for Second Quarter of 2024 were $42.5 Million, up 13% Year-over-Year; First Half 2024 Total Revenues were $80.2 Million, up 18% Year-over-Year
Second Quarter 2024 Adjusted EBITDA of $9.1 Million, Representing 51% Increase Year-over-Year; First Half 2024 Adjusted EBITDA of $16.6 Million, up 68% Year-over-Year
Robust First Half 2024 Performance and Expectation for Similar Cadence of Financial Results for Second Half of the Year Supports Reiteration of Full-Year Revenue Guidance of $158 Million-$162 Million and Adjusted EBITDA of $28 Million-$32 Million
Conference Call and Live Webcast Today at 8:30 AM ET
REHOVOT, Israel and HOBOKEN, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced financial results for the three and six months ended June 30, 2024.
“Our strong financial performance is indicative of the successful execution of our growth strategy as we continue to effectively leverage our multiple diverse commercial catalysts, including our six FDA-approved products,” said Amir London, Kamada’s Chief Executive Officer. “With total revenues for the first half of 2024 of $80.2 million, which represents year-over-year growth of 18%, adjusted EBITDA of $16.6 million, up 68% year-over-year and representing a 21% margin of revenues, we achieved the top- and bottom-line profitable growth anticipated in our business. In addition, during the first six months of the year, we generated $15.0 million of cash provided by operating activities, which demonstrates our ability to convert our reported adjusted EBITDA to operational cash flow.”
“Based on our continued strong performance and expectation for a cadence of financial results in the second half of 2024 consistent with those achieved in the first six months of the year, we are reiterating our full-year 2024 revenue guidance of $158 million to $162 million, and our adjusted EBITDA guidance of $28 million to $32 million. Importantly, we continue to pursue compelling new business development opportunities, leveraging our financial strength. These opportunities are expected to support continued growth at double-digit rates beyond 2024,” added Mr. London.
“Patient enrollment continues in our ongoing pivotal Phase 3 InnovAATe clinical trial for the inhaled Alpha-1 Antitrypsin therapy. Last quarter, we filed an IND amendment with the FDA consisting of a revised Statistical Analysis Plan (SAP) and study protocol, which, if approved, may allow for the acceleration of the program. We continue to expect further FDA feedback before the end of this year,” concluded Mr. London.
Financial Highlights for the Three Months Ended June 30, 2024
Total revenues were $42.5 million in the second quarter of 2024, a 13% increase from the prior year comparable quarter. The increase in revenues was primarily attributable to increased sales of KEDRAB due to increased market share in the U.S., as well as increased sales of CYTOGAM due to increased demand in the U.S. market.
Gross profit and gross margins were $19.0 million and 45%, respectively, in the second quarter of 2024, compared to $14.4 million and 39%, respectively, reported in the prior year comparable quarter.
Operating expenses, including R&D, S&M, G&A and other expenses, totaled $13.3 million in the second quarter of 2024, as compared to $11.8 million in the second quarter of 2023. The increase in operating expenses was primarily attributable to an increase in S&M costs associated with the marketing activities in the U.S., as well as increased R&D costs, primarily due to advancing the Inhaled AAT clinical trial.
Net income was $4.4 million, or $0.08 per share, in the second quarter of 2024, as compared to net income of $1.8 million, or $0.04 per share, in the second quarter of 2023.
Adjusted EBITDA, as detailed in the tables below, was $9.1 million in the second quarter of 2024, a 51% increase as compared to $6.0 million in the second quarter of 2023.
Cash provided by operating activities was $14.0 million in the second quarter of 2024, as compared to cash provided by operating activities of $1.8 million in the second quarter of 2023.
Financial Highlights for the Six Months Ended June 30, 2024
Total revenues for the first six months of 2024 were $80.2 million, an 18% increase from the $68.2 million generated in the first six months of 2023. The increase in revenues was primarily attributable to increased sales of KEDRAB due to increased market share in the U.S., as well as increased sales of CYTOGAM due to increased demand for the product in the U.S. market.
Gross profit and gross margins for the first six months of 2024 were $35.7 million and 45%, respectively, compared to $26.3 million and 39%, respectively, in the first half of 2023.
Operating expenses, including R&D, S&M, G&A and other expenses, totaled $26.0 million in the first six months of 2024, as compared to $23.4 million in the first half of 2023. The increase in operating expenses was primarily attributable to an increase in S&M costs associated with the marketing activities in the U.S., as well as increased R&D costs, primarily due to advancing the Inhaled AAT clinical trial.
Net profit for the first six months of 2024 was $6.8 million, or $0.12 per share, as compared to net profit of $3,000 or less than one cent per share, in the first six months of 2023.
Adjusted EBITDA, as detailed in the tables below, was $16.6 million in the first six months of 2024, a 68% increase as compared to $9.9 million in the first six months of 2023.
Cash provided by operating activities during the first six months of 2024 was approximately $15.0 million, as compared to cash used in operating activities of $1.0 million during the first six months of 2023. The change was correlated to the changes in the Company’s working capital.
Balance Sheet Highlights
As of June 30, 2024, the Company had cash, cash equivalents, and short-term investments of $56.5 million, as compared to $55.6 million on December 31, 2023.
Fiscal Year 2024 Guidance
Kamada continues to expect to generate fiscal year 2024 total revenues in the range of $158 million to $162 million, and adjusted EBITDA in the range of $28 million to $32 million, representing double digit top- and bottom-line growth year-over-year.
Conference Call
Kamada management will host an investment community conference call on Wednesday, August 14, 2024, at 8:30am Eastern Time to present the Company’s results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-877-407-0792 (from within the U.S.) or 1-809-406-247 (from Israel) or 1-201-689-8263 (International) using conference ID 13747542. The call will also be webcast live on the Internet at:
https://viavid.webcasts.com/starthere.jsp?ei=1678713&tp_key=b3f21d48c3.
MediWound Reports Second Quarter 2024 Financial Results and Provides Company Update
https://finance.yahoo.com/news/mediwound-reports-second-quarter-2024-110000628.html
Completed Construction of New NexoBrid® Manufacturing Facility
€16.25 Million EIC Funding Expedites EscharEx® Development for Diabetic Foot Ulcers, Significantly Expanding the Addressable Market; Phase III Study for Venous Leg Ulcers to Begin in H2 2024
$25 Million Strategic Investment Led by Mölnlycke Health Care
Conference Call Today, August 14 at 8:30am Eastern Time
YAVNE, Israel, Aug. 14, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the second quarter ended June 30, 2024, and provided a corporate update.
“This has been another strong quarter for MediWound as we continue to successfully execute our strategic plan,” said Ofer Gonen, Chief Executive Officer of MediWound. “We have completed construction of our new GMP-compliant, state-of-the-art manufacturing facility for NexoBrid® addressing the growing global demand for this product. We are well on track to achieving our two remaining key goals: accelerating NexoBrid's revenue growth and initiating the Phase III clinical trial for EscharEx.
In addition to these strategic milestones, we secured €16.25 million in funding from the European Innovation Council (EIC) to expand EscharEx’s indications to include diabetic foot ulcers, significantly increasing the product’s total addressable market. Furthermore, we raised $25 million in financing led by Mölnlycke Health Care, an industry leader, demonstrating confidence in our technology and further strengthening our financial position.”
Second Quarter 2024 Highlights, Recent Developments and Upcoming Milestones:
NexoBrid
Construction of our new, state-of-the-art GMP-compliant manufacturing facility is complete. Commissioning will begin soon, aiming for full operational capacity in 2025. This expansion will increase manufacturing capacity sixfold.
U.S. launch by Vericel continues to build momentum. Approximately 70 burn centers have completed submissions to Pharmacy and Therapeutics (P&T) committees, with 40+ centers already obtaining approval, and nearly all of those placing initial product orders. Vericel reported a notable increase in hospital orders and the number of patients treated, driving a revenue growth of 76% over prior quarter.
Results from the U.S. NexoBrid Expanded Access Protocol (NEXT) were positive and aligned with the findings from Phase III studies. Conducted at 29 burn centers across the U.S. with 239 patients enrolled, and designed to ensure continuous availability until commercialization, NEXT reaffirmed NexoBrid's proven safety and efficacy in eschar removal, significantly reducing the need for surgical procedures in burn patients.
U.S. Food and Drug Administration (FDA) approval of the pediatric indication is expected in the third quarter of 2024.
EscharEx
Phase III study of EscharEx for treating venous leg ulcers (VLUs) is scheduled to start in the second half of 2024, as planned.
€16.25 million in funding from the EIC will accelerate the clinical development of EscharEx for treating diabetic foot ulcers (DFUs). This will expedite MediWound's DFU program, and its associated revenue projections by four years. DFUs are more prevalent than VLUs, with a higher percentage of them requiring debridement. Preparations for the DFU Phase II/III study are currently underway.
Results of EscharEx Phase II ChronEx study were published in THE LANCET’s eClinicalMedicine journal. EscharEx outperformed non-surgical SOC in debridement and promotion of healthy granulation tissue.
Corporate Developments
Secured $25 million in a strategic private investment in public equity with several new and existing investors. Mölnlycke Health Care, a global leader in innovative wound care solutions, led the PIPE and has entered into a collaboration agreement with MediWound.
Company included in the Russell 3000® Index, as part of the 2024 Russell indexes annual reconstitution.
Second Quarter 2024 Financial Highlights
Revenue: Revenue for the second quarter of 2024 was $5.1 million, up from $4.8 million in the same period of 2023. The increase is primarily attributed to revenue from Vericel.
Gross Profit: Gross profit for the second quarter of 2024 was $0.4 million, representing 9% of total revenue, compared to $1.1 million, representing 24% of total revenue in the second quarter of 2023. The decrease in gross margin is mainly due to changes in the revenue mix and nonrecurring production costs.
Expenditures:
Research and Development: R&D expenses for the second quarter of 2024 were $1.9 million, compared to $2.0 million in the same period of 2023.
Selling, General, and Administrative: SG&A expenses for the second quarter of 2024 were $3.0 million, compared to $3.1 million in the second quarter of 2023.
Operating Results: Operating loss for the second quarter of 2024 was $4.5 million, compared to an operating loss of $4.0 million in the second quarter of 2023.
Net Profit (Loss): Net loss for the second quarter of 2024 was $6.3 million, or $0.68 per share, compared to a net profit of $0.9 million, or $0.10 per share, in the second quarter of 2023. This change is primarily due to financial expenses driven by the revaluation of warrants.
Non-GAAP Adjusted EBITDA: Adjusted EBITDA for the second quarter of 2024 was a loss of $3.4 million, compared to a loss of $3.0 million in the same period of 2023.
Year-to-Date 2024 Financial Highlights
Revenue: Total revenues for the first half of 2024 were $10.0 million, up from $8.6 million in the first half of 2023. The increase is mainly attributed to revenue from Vericel and new contracts with the U.S. Department of Defense (DoD).
Gross Profit: Gross profit for the first half of 2024 was $1.1 million, or 11% of total revenue, compared to $2.0 million, or 23% of total revenue, in the first half of 2023.
Expenditures:
Research and Development: R&D expenses for the first half of 2024 were $3.4 million, compared to $4.1 million in the first half of 2023. This decrease is primarily due to the completion of the EscharEx Phase II study.
Selling, General, and Administrative: SG&A expenses for the first half of 2024 were $5.9 million, down from $6.2 million in the first half of 2023.
Operating Results: Operating loss for the first half of 2024 was $8.2 million, compared to an operating loss of $8.4 million in the same period of 2023.
Net Loss: Net loss for the first half of 2024 was $16.0 million, or $1.73 per share, compared to a net loss of $2.8 million, or $0.32 per share, in the first half of 2023. The increase in net loss is primarily attributable to financial expenses from the revaluation of warrants, which amounted to $8 million, driven by a 53% increase in the Company’s share price.
Adjusted EBITDA: Adjusted EBITDA for the first half of 2024 was a loss of $6.2 million, compared to a loss of $6.4 million in the first half of 2023.
Balance Sheet Highlights
As of June 30, 2024, the Company had cash and cash equivalents, restricted cash, and deposits totaling $29.7 million, compared to $42.1 million as of December 31, 2023. In the first half of 2024, the Company received $0.6 million from the exercise of Series A warrants. The Company utilized $12.9 million to fund its activities in the first half of 2024, including $4.3 million allocated to CAPEX primarily for facility scale-up.
On July 15, the Company successfully raised $25 million through a PIPE offering. Following the PIPE, the issued and outstanding shares of NIS 0.07 par value were 10,786,423.
Conference Call
MediWound management will host a conference call for investors on Wednesday, August 14, 2024, beginning at 8:30 a.m., Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-833-630-1956 (in the U.S.), 1-80-921-2373 (Israel), or 1-412-317-1837 (outside the U.S. & Israel). The call will be available via webcast by clicking HERE or on the Events & Presentations page of Company’s website.
A replay of the call will be available on the Company’s website at www.mediwound.com.
Can-Fite Announces Exercise of Warrants for Approximately $5.0 Million in Gross Proceeds
https://finance.yahoo.com/news/fite-announces-exercise-warrants-approximately-230100301.html
RAMAT GAN, Israel, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 2,857,143 American Depositary Shares (ADSs), having an exercise price of $1.75 per ADS, issued by Can-Fite in January 2023 and November 2023. The ADSs representing ordinary shares issuable upon exercise of the warrants are registered pursuant to effective registration statements on Form F-3 (File No. 333-276000) and Form F-1 (File No. 333-269485). The closing of the offering is expected to occur on or about August 12, 2024, subject to satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
In consideration for the immediate exercise of the warrants for cash, Can-Fite will issue new unregistered warrants to purchase up to 5,714,286 ADSs. The new warrants will have an exercise price of $2.25 per ADS, will be immediately exercisable until the five-year anniversary from the date of issuance with respect to 2,987,012 new warrants and the twenty-month anniversary from the date of issuance with respect to 2,727,274 new warrants.
The gross proceeds to Can-Fite from the exercise of the warrants are expected to be approximately $5.0 million, prior to deducting placement agent fees and offering expenses. The Company intends to use the net proceeds for funding research and development and clinical trials and for other working capital and general corporate purposes.
The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act"), and, along with the ADSs issuable upon exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Can-Fite has agreed to file a registration statement with the SEC covering the resale of the shares of ADSs issuable upon exercise of the new warrants.
BioLineRx to Report Second Quarter 2024 Results on August 15, 2024
Management to Hold Conference Call at 8:30 a.m. EDT
TEL AVIV, Israel, Aug. 8, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it will release its unaudited financial results for the second quarter ended June 30, 2024 on Thursday, August 15, 2024, before the U.S. markets open.
The Company will host a conference call at 8:30 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer.
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until August 19, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
In effect a 1:25 R/S ?
0.5418 +0.0685 (+14.4729%)
As of 11:02 AM EDT. Market Open.
Negotiations underway?
The gain was indeed short lived.
MediWound Announces Positive Results from the U.S. NexoBrid® Expanded Access Protocol (NEXT)
https://finance.yahoo.com/news/mediwound-announces-positive-results-u-113000398.html
.
NEXT Confirms NexoBrid's Proven Safety and Efficacy in Eschar Removal, Significantly Reducing Surgical Procedures for Burn Patients
YAVNE, Israel, Aug. 05, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced the positive results of the NEXT—an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid® in burn centers until its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this life-saving treatment, and facilitated the accumulation of real-world safety and clinical data for NexoBrid.
Jeremy Goverman, MD, FACS, Associate Professor of Surgery at Harvard Medical School, commented, “The NEXT results reaffirm the significant benefits of NexoBrid in managing severe burns. This enzymatic debridement agent accelerates the debridement process and reduces the need for surgical interventions, ultimately enhancing patient outcomes. The findings from NEXT are consistent with data from the DETECT and CIDS Phase III trials, reinforcing the critical role that NexoBrid should play in standard burn care protocols.”
NEXT, an open-label, single-arm treatment protocol was conducted at 29 burn centers across the U.S. 239 patients, including 215 adults and 24 children, with deep partial and full-thickness thermal burns covering up to 30% of the total body surface area (TBSA) were treated with NexoBrid.
Key Results of the NEXT Protocol Include:
Efficacy (findings were consistent with Phase III studies results):
94.9% of adults and 100% of children achieved complete debridement.
Only 4.2% of adults required surgical excision for eschar removal after NexoBrid treatment, and none in the pediatric group.
The mean (± SD) percent of wound area surgically excised for adults was 3.6% (±18.33), and 0% for children.
The time to complete eschar removal was less than one day for both adults and children.
Healing and Hospitalization:
The median time to wound closure was 22 days (95% CI: 22, 23) for adults and 28 days (95% CI: 18, 32) for children.
The median time of hospitalization duration was 10 days (95% CI: 8, 11) for adults and 10 days (95% CI: 5, 14) for children.
Safety: The safety data was consistent with the established safety profile of NexoBrid, and no new safety concerns were identified by the Data Safety and Monitoring Board (DSMB).
Benefit-Risk Ratio: The overall benefit-to-risk ratio of NexoBrid treatment remains favorable.
About NexoBrid
NexoBrid® is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid® is approved in over 40 countries, including the United States, European Union, and Japan. It has been designated as an orphan biologic drug in all these territories.
NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access protocol (NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.
A partner and/or a stockpiling contract by Barda
might just do it.
MediWound to Report Second Quarter 2024 Financial Results
https://finance.yahoo.com/news/mediwound-report-second-quarter-2024-120000328.html
Conference Call and Webcast Scheduled for Wednesday, August 14th at 8:30 am Eastern Time
YAVNE, Israel, Aug. 02, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the second quarter ended June 30, 2024 on Wednesday, August 14, 2024.
Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates, and answer questions.
Dial-in and call details are as follows:
Conference Call & Webcast Details
Toll-Free:
1-833-630-1956
Israel:
1-80-921-2373
International:
1-412-317-1837
Webcast:
Click HERE
To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call. An archived version of the webcast will be available for replay on the Investors section of the MediWound website.
Methinks that 4 companies are checking RDHL's data:
Abbvie, Janssen, BMS and PFE.
Hope some sort of coop is to materialize soon by any one of them.
NexoBrid Revenue Growth of 76% Over Prior Quarter
NexoBrid launch progressing with approximately 70 Pharmacy and Therapeutics (P&T) committee submissions, more than 40 burn centers obtaining approval and approximately 40 centers placing initial orders
FDA approval of pediatric indication for NexoBrid expected in the third quarter of 2024
All above from
https://finance.yahoo.com/news/vericel-reports-second-quarter-2024-115500147.html