BLRX - A sad sight to see.
Does anybody see any possibility of recovery?
Comments appreciated.
Tia.

Improvement in Patient with Decompensated Liver Cirrhosis Upon Treatment with Namodenoson
Can-Fite BioPharma Ltd.

Liver cirrhosis treatment global market is estimated to reach $29.2 billion by 2030

Ramat Gan, Israel, July 01, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, announced today that a patient with liver decompensated cirrhosis who was treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use showed an improvement in liver indices. This drug candidate is currently used in a pivotal Phase III study for patients with advanced liver cancer and a Phase IIb study for MASH (metabolic dysfunction-associated steatohepatitis).

Decompensated cirrhosis is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression.

In the past year Can-Fite has initiated a compassionate use program at the Soroka Medical Center, Beersheva, Israel, for the treatment of decompensated patients with Namodenoson. The first patient, a 63-year-old female with a history of decompensated primary biliary cirrhosis is now treated for one year with Namodenoson. Prior to the treatment with Namodenoson and despite best medical care for her underlying disease, she developed ascites and was admitted to the hospital with acute variceal bleeding. Currently, the patient shows improvement in liver function tests hematological parameters and FibroScan values and has not experienced any event of decompensation since starting treatment with Namodenoson. Namodenoson is known to induce liver protective effects in other liver pathologies, and Phase IIa data in patients suffering from MASH (metabolic dysfunction-associated steatohepatitis), responded positively to the drug, showing anti-inflammatory, anti-steatotic, and antifibrotic effects with a very favorable safety profile.

Ohad Etzion, MD, Director, Department of Gastroenterology and Liver Diseases at the Soroka Medical Center, Beer Sheva, Israel, the Investigator and Initiator of this study commented, “We were very much encouraged by the response of the first patient with decompensated liver cirrhosis who showed a rapid and sustained response to the drug with an improvement with liver indices. We plan to treat more patients and hopefully see an improvement of liver function in this devastating disease.

Decompensated cirrhosis is defined as an acute deterioration in liver function, with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression. An estimated 10.6 million people globally had decompensated cirrhosis in 2017, with few treatment options available aside from liver transplants if the decompensated cirrhosis has reached an advanced stage. Underscoring the need for an effective treatment, the American Liver Foundation states there are more people who need a liver than supply available, and some people can be on the wait list for a liver transplant for more than 5 years. The treatment of liver cirrhosis globally is estimated to become an approximately $29.2 billion market by 2031.

Positive Results from Osteoarthritis Clinical Study in Dogs Reported by Can-Fite’s Partner Vetbiolix

https://finance.yahoo.com/news/positive-results-osteoarthritis-clinical-study-

The canine osteoarthritis market is projected to reach $3 billion by 2028

RAMAT GAN, Israel, June 28, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that its veterinary partner Vetbiolix reported positive results in an osteoarthritis multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite’s veterinary commercialization partner which is covering all costs associated with veterinary clinical development, concluded successfully the study interim analysis.

After Piclidenoson proved efficacious, Vetbiolix can exercise the option to enter into a full in license agreement with Can-Fite and be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval.

The study looked at the effect of 90 days treatment with Piclidenoson at 100 µg/kg and 500 µg/kg twice daily orally in dog patients with osteoarthritis. The primary objective was the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire for the assessment of symptoms severity evaluated on dog’s mobility. The secondary objectives included Visual Analog Scale (VAS) for pain assessment by pet parents and Numerical Rating Score (NRS) for (i) lameness and (ii) pain assessment by the veterinarian. The study reached the primary and secondary end points with a dose and time dependent inhibitory effect of piclidenoson on LOAD and VAS and NRS, demonstrating significant improvement in clinical status and decrease in pain in the 500 µg/kg dose.

The canine osteoarthritis market is projected to reach $3 billion by 2028.

There is a clear need in the market for a safe and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs) which only treat symptoms and carry significant harmful side effects and an injectable disease-modifying osteoarthritis drug (DMOAD) that targets the progression of the disease.

"We are very much encouraged by the positive results in the osteoarthritis dog clinical study and hope Piclidenoson can be used as an efficacious drug with this unmet clinical indication," stated Can-Fite CSO Dr. Pnina Fishman. "This veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canines, while also potentially contributing near-term revenues. We are very pleased to work productively with the team at Vetbiolix."

About Piclidenoson

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.

Can-Fite: Breakthrough Findings Demonstrate Namodenoson Anti-cancer and Protective Effect Mechanism in the Liver

https://finance.yahoo.com/news/fite-breakthrough-findings-demonstrate-namodenoson-110000011.html

PETACH TIKVA, Israel, June 24, 2024--(BUSINESS WIRE)--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 announces that company scientists came up with breakthrough findings showing that the anti-cancer and protective effects in the liver are conferred via the signalling protein adiponectin. This very important positive cytokine plays a pivotal role in regulating anti-inflammatory, anti-cancer, metabolic and insulin resistance. Namodenoson increases adiponectin production in pre-clinical studies and in humans.

The data will be presented at the 20th Annual Congress of International Drug Discovery Science & Technology, China Branch (IDDST-2024), September 12-14, Shanghai, China. This conference will host 300 leading scientists from the academia and industry worldwide to discuss the latest developments in drug discovery and therapy.

"We are very much enthused by the breakthrough findings that explain the dual mechanism of Namodenoson working as an anti-cancer agent in the liver and also inducing a liver protective effect," stated Dr. Pnina Fishman, Can-Fite CSO & Chairperson.

Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and also in a Phase IIb study in patients with MASH.

Form 6-K - Report of foreign issuer

On June 16, 2024, Biokine Therapeutics Ltd. (“Biokine”), filed a complaint with the District Court of Jerusalem against BioLineRx Ltd. (the “Company”), entitled Biokine Therapeutics Ltd. v. BioLineRx Ltd., T.A. 31677-06-24. The complaint alleges breach of contract and a purported failure to make certain payments to Biokine under the Company’s in-licensing agreement with Biokine for motixafortide. The lawsuit seeks compensatory damages in the amount of approximately $6.5 million and a declaratory judgment in favor of Biokine. The Company intends to vigorously defend itself against such action.

Another example:

GeoVax Receives BARDA Project NextGen Award to Conduct Phase 2b Clinical Study Evaluating the Company's Next-Generation COVID-19 Vaccine Candidate, GEO-CM04S1

https://finance.yahoo.com/news/geovax-receives-barda-project-nextgen-110000120.html

The direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made separate awards through its Clinical Studies Network to support execution of the study. That funding will represent approximately $343M from the Project NextGen program for a CRO to execute the clinical trial using GeoVax's vaccine.

Compugen to Present at Upcoming Antibody Industrial Symposium

https://finance.yahoo.com/news/compugen-present-upcoming-antibody-industrial-110000879.html

HOLON, Israel, June 17, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that Pierre Ferré, Ph.D, SVP, Preclinical Development and Corporate Operations, Compugen will present a case study on clinical dose selection for TIGIT monospecific and bispecific antibodies at the Antibody Industrial Symposium taking place June 20-21, 2024, Montpellier, France.

Event: 12th Antibody Industrial Symposium, Montpellier, France
Date: Friday, June 21, 2024
Presenter: Pierre Ferré, Ph.D., SVP, Preclinical Development and Corporate Operations, Compugen
Presentation title: Case study on clinical dose selection for TIGIT monospecific and bispecific antibodies

3.9300 +0.3000 (+8.2645%)
As of 9:49 AM EDT. Market Open.
Volume 96,471
Avg. Volume 35,830

3.2900 +0.1500 (+4.79%)
As of 12:42 PM EDT. Market Open.
Volume 94,516
Avg. Volume 31,314
Momentum continues, I wonder what's up.

BioLineRx (NASDAQ:BLRX) is a company attempting to commercialize therapeutics for the treatment of various cancers and rare diseases including sickle cell disease. The company’s recent announcements around those projects deserve particular attention and make the stock attractive.

BioLineRx truly does look like a biotech stock that’s about to move much higher. Interested investors should read this recent portfolio update from May 28. The company’s FDA-approved multiple myeloma treatment, Aphexda, is growing steadily in its first full quarter of post-approval adoption.

The drug is quickly making its way into the network of transplant centers and is placed at 26% of all institutions in the U.S. currently. BioLineRx expects that number to rise to 35% by the end of the second quarter and could rise to 60% by the end of the year.

The biotech is currently running at a slight net loss of $0.7 million but benefits from continued progress in clinical trials relating to other diseases including sickle cell disease. In short, there seem to be multiple reasons to bet on BLRX stock at the moment.

https://finance.yahoo.com/news/millionaire-makers-7-stocks-buy-191700533.html

3.1500 +0.3900 (+14.1304%)
As of 10:44 AM EDT. Market Open.
On Highter Than Average Volume:
Volume 93,423
Avg. Volume 26,150

3.0999 +0.3399 (+12.31%)
As of 9:50 AM EDT. Market Open.
Something's Cooking!

Can-Fite Received IRB Approval for the Treatment of Pancreatic Cancer with Namodenoson in a Phase IIa Study

https://finance.yahoo.com/news/fite-received-irb-approval-treatment-110000599.html

Namodenoson showed efficacy in pre-clinical models via a definitive molecular mechanism of action

PETACH TIKVA, Israel, June 10, 2024--(BUSINESS WIRE)--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 that it received an approval from the Institutional Review Board (IRB) of Rabin Medical Center, a leading medical institution in Israel where the study will be conducted. The approved protocol has been submitted now to the Ministry of Health (MOH).

"This Phase IIa study is designed as an open-label one, enabling us to assess the safety and potential efficacy of Namodenoson in pancreatic cancer patients whose disease has progressed despite first-line treatment. Our positive Namodenoson data in pancreatic carcinoma experimental models together with the positive data in the Phase II advanced liver cancer study, with a patient showing overall survival of >7 years, encouraged us to initiate the current Phase IIa study," stated Can-Fite’s Medical Director Dr. Michael Silverman.

The protocol of the clinical study is CF102-222PC entitled: "A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma," ClinicalTrials.gov Identifier: NCT06387342.

The study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population. All patients will receive oral Namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

The study will be conducted by Dr. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel.

Namodenoson recently received peer-reviewed recognition for its efficacy findings in pancreatic cancer including from the American Association of Cancer Research (AACR) which accepted Can-Fite’s study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/ß-catenin Signaling Pathway" for a poster presentation at the AACR Special Conference on Pancreatic Cancer, and from Biomolecules, a scientific journal focused on the function and mechanism of bioactive molecules, which published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/ß-catenin, NF-?B, and RAS Signaling Pathways."

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

RedHill Biopharma Ltd. (RDHL)
0.4220 -0.0380 (-8.26%)
As of 9:45 AM EDT. Market Open.
Timberrrrrrrrrrrrrrrrr!

Real news:
6K
Redhill Biopharma Ltd. (the “Company”) announced that on June 4, 2024 Ms. Alla Felder submitted to the board of directors (the “Board”) a notice of resignation from her position as a member of the Board, effective June 6, 2024. Ms. Felder’s resignation from the Board is due to personal reasons and not as a result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
Mr. Dror Ben-Asher, Chairman of the Board, commented, “On behalf of the entire Board, I thank Alla for the valuable contributions she has provided to the Company as a Board member.”
----------------------------------------------------------------------------------------------------------------
Rats leaving the sinking ship, i wonder?

Momentum continues,
i wonder why?

Can-Fite Updates on its Advanced Liver Cancer Pivotal Phase 3 Study

https://finance.yahoo.com/news/fite-updates-advanced-liver-cancer-110000128.html

Namodenoson granted Orphan Drug and Fast track status from the FDA

RAMAT GAN, Israel, June 05, 2024--(BUSINESS WIRE)--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 an update on the status of its oncological lead drug candidate, Namodenoson in the treatment of advanced liver cancer. The Phase 3 pivotal study now has 31 recruiting medical centers in Europe, Israel and the US. Namodenoson has Orphan Drug status with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency, as well as Fast Track Status with the FDA. A compassionate use program has also been ongoing in Israel and Romania.

In the former Phase 2 study, conducted in patients with advanced liver cancer, Namodenoson prolonged survival, patients had good quality of life, and in two patients, clearance of peritoneal carcinomas have been reported. In addition, one patient had a long term complete response of more than 7 years.

Liver cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B. According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. The market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.

The current double blind, placebo-controlled trial, known as LIVERATION, will enroll 450 patients diagnosed with advanced liver cancer (hepato-cellular carcinoma) and underlying Child Pugh B7 (CPB7) cirrhosis. Patients will be randomized to oral treatment with either 25 mg of Namodenoson or a matching placebo, in a ratio of 2:1 given twice daily as a second- or third-line treatment. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will also be assessed. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated.

0.4700 +0.0225 (+5.0279%)
As of 2:08 PM EDT. Market Open.
Rise and Shine.

RedHill Announces a New Patent Covering Opaganib in Combination with Immune Checkpoint Inhibitors, Valid Through 2040

https://finance.yahoo.com/news/redhill-announces-patent-covering-opaganib-110000734.html

New Chinese patent notice of allowance issued covering opaganib in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response[1]. Provides protection for opaganib's potential use in combination with a range of approved and in-development (ICIs) across a growing range of indications[2] through 2040

ICIs have become a cornerstone in cancer treatment, having been hailed as a major breakthrough by oncologists, with the global ICI market expected to exceed $100 billion by 2028, including Merck's Keytruda (pembrolizumab) and BMS' Yervoy (ipilimumab)[3]

Opaganib, a host-directed and potentially broad acting twice-daily oral, small molecule with a demonstrated safety & efficacy profile, is in development for multiple oncology, viral and inflammatory indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure

TEL-AVIV, Israel and RALEIGH, N.C., June 3, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new Chinese patent notice of allowance for opaganib[4] in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response, providing protection for opaganib's potential use with a range of approved and in-development immune checkpoint inhibitors (ICIs) across a growing range of indications through 2040. The patent will be issued by the Chinese National Intellectual Property Administration (CNIPA) (Chinese Patent Application No.: 202080013805.3 issued May 24, 2024).


"ICIs have become a cornerstone in cancer treatment, having been hailed as a major breakthrough by oncologists, with the global ICI market expected to exceed $100 billion by 2028, including Merck's Keytruda (pembrolizumab) and BMS' Yervoy (ipilimumab)," said Guy Goldberg, RedHill's Chief Business Officer. "This exciting new patent is based on compelling data from a range of in vivo experiments showing significant improvements in outcomes in combination with selected ICIs. China has been a world leader in embracing ICI-based therapy[5] and this is an important addition to the strong patent portfolio protecting opaganib."

About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including prostate cancer and cholangiocarcinoma (bile duct cancer), gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness.

Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Opaganib has been selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, both funded by the NIH: The Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the HHS National Institutes of Health, for the nuclear medical countermeasures (MCM) product development pipeline selected opaganib for development as a potential treatment for Acute Radiation Syndrome (ARS); and the Chemical Medical Countermeasures (Chem MCM) Program and Chemical Countermeasures Research Program (CCRP), managed respectively by the Administration for Strategic Preparedness and Response (ASPR) / Biomedical Advanced Research and Development Authority (BARDA) and NIH/NIAID selected opaganib for evaluation as a potential medical countermeasure (MCM) against Sulfur Mustard exposure.

Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.

Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in medRxiv.

Opaganib has received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.

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[6], and Aemcolo®, for the treatment of travelers' diarrhea in adults[7]. 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 U.S. government collaborations for development for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, 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.

Item 3.01 Notice of Delisting or Failure to Satisfy a Continug le Ruor Standard; Transfer of Listing.ed Listin

On May 28, 2024, Pluri Inc., or Pluri or the Company, received a deficiency letter, or the Nasdaq Letter, from the Listing Qualifications Department of The Nasdaq Stock Market LLC, or Nasdaq, notifying the Company that it is not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires the Company to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing on The Nasdaq Capital Market, or the Stockholders’ Equity Requirement, nor is it in compliance with either of the alternative listing standards, market value of listed securities of at least $35 million or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.

Pursuant to the Nasdaq Letter, the Company has 45 calendar days from the date of the Nasdaq Letter to submit a plan to regain compliance and the Company intends to submit such a plan during this period. If it accepts the plan, Nasdaq can grant an extension of up to 180 calendar days from the date of the Nasdaq Letter to evidence compliance. In the event the plan is not accepted by Nasdaq, or in the event the plan is accepted and the 180-day extension period granted but the Company fails to regain compliance within such plan period, the Company would have the right to a hearing before an independent panel. The hearing request would stay any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the panel following the hearing.

The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. However, there can be no assurance that Nasdaq will grant the Company’s request for an extension or that the Company will ultimately regain compliance with all applicable requirements for continued listing.

Neither the Nasdaq Letter nor the Company’s noncompliance have an immediate effect on the listing or trading of the Company’s common shares, which will continue to trade on The Nasdaq Capital Market under the symbol “PLUR”.
-------------------------------------------------------------------------------------------------------
Seems that a r/s was not sufficient

LOL, it seems BLRX will surpass
$1 sooner than i had anticipated!

I am pretty sure no rs will be needed
in order to regain Naz compliance.

Compugen to Receive Milestone Payment Triggered by Dosing of First Patient in the Second Phase 3 Trial Evaluating Rilvegostomig

https://finance.yahoo.com/news/compugen-receive-milestone-payment-triggered-110000791.html

Phase 3 trial evaluating rilvegostomig as monotherapy and in combination with AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan in first-line nonsquamous non-small cell lung cancer

Broadening the assessment of rilvegostomig reinforces Compugen's partnering strategy to expand opportunities for its pipeline

Compugen to receive $5 million milestone payment from AstraZeneca

HOLON, Israel, May 30, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced it is entitled to receive a milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN) triggered by the dosing of the first patient in a Phase 3 trial evaluating rilvegostomig, AstraZeneca's PD-1/TIGIT bispecific antibody. The TIGIT component of rilvegostomig is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902. Both rilvegostomig and COM902 are designed to have reduced Fc effector function.

The trial, called TROPION-Lung10, is evaluating the efficacy and safety of rilvegostomig as monotherapy and in combination with datopotamab deruxtecan (Dato-DXd), AstraZeneca and Daiichi Sankyo's (TSE: 4568) TROP2-directed antibody drug conjugate versus pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with high PD-L1 expression (TC = 50%) and without actionable genomic alterations. The trial is sponsored by AstraZeneca in collaboration with Daiichi Sankyo and is expected to enrol approximately 675 patients in more than 14 countries. Further details about TROPION-Lung10 are available on ClinicalTrials.gov, identifier: NCT06357533.

"We are very excited to see the advancement of rilvegostomig into its second Phase 3 trial by AstraZeneca in collaboration with Daiichi Sankyo, two global leaders in oncology," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "TROPION-Lung10 follows the start of the ARTEMIDE-Biliary01 Phase 3 trial evaluating rilvegostomig in biliary tract cancer, for which we received a $10 million milestone payment. Now, after dosing the first patient in this lung cancer trial, we are eligible to receive a $5 million milestone payment from AstraZeneca. Broadening the assessment of rilvegostomig reinforces our partnering strategy to expand opportunities for our pipeline and brings us closer to realizing potential future milestone payments and royalties."

The ARTEMIDE-Biliary01 Phase 3 trial is evaluating the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in patients with biliary tract cancer after surgical resection with curative intent. Further details about the ARTEMIDE-Biliary01 trial are available on ClinicalTrials.gov, identifier: NCT06109779.

About the Compugen-AstraZeneca license agreement

In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen's monospecific antibodies that bind to TIGIT, including COM902, for the development of bispecific and multispecific antibody products, excluding such bispecific and multispecific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. Compugen has received $35.5 million in upfront and milestone payments to date and is eligible to receive an additional $5 million milestone payment as described in this press release. Compugen is eligible to receive up to an aggregate milestone amount of $200 million in development and regulatory milestones for the first and second indications for the first product and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional bi- or multi-specific products are developed based on Compugen's monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen.

Rilvegostomig (previously AZD2936) is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902. Rilvegostomig is in Phase 3 development by AstraZeneca through this license agreement. Both rilvegostomig and COM902 are designed to have reduced Fc effector function to avoid depletion of CD8+ T cells.

BioLineRx Announces Clinical Trial Agreement with St. Jude Children's Research Hospital, Inc. to Evaluate Motixafortide for CD34+ Hematopoietic Stem Cell (HSC) Mobilization For Gene Therapy Applications in Sickle Cell Disease (SCD)

https://finance.yahoo.com/news/biolinerx-announces-clinical-trial-agreement-110000405.html

- Investigator-initiated study includes leading researchers in SCD gene therapy clinical development from St. Jude Children's Research Hospital, Inc. and two other clinical sites -

- New trial to expand ongoing clinical research of motixafortide for mobilization of HSCs in patients with SCD -

TEL AVIV, Israel, May 30, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced a multi-center Phase 1 clinical trial sponsored by St. Jude Children's Research Hospital, Inc. to evaluate motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with sickle cell disease (SCD). Investigators in the trial from St. Jude Children's Research Hospital, Inc. and two other clinical sites have extensive SCD gene therapy clinical development experience and are recognized leaders in the field.

Hematopoietic stem cell transplantation after genetic modification is potentially curative for patients with SCD. Significant quantities of HSCs (minimum 16.5-20 million cells/kg) are required for genetic manipulation and transplant success, however, the most commonly used drug for collection of stem cells, granulocyte colony-stimulating factor (G-CSF), is contraindicated in patients with SCD. Peripheral blood mobilization of stem cells using the mobilization agent plerixafor is the current strategy to collect HSCs for SCD gene therapies, however limitations exist including the need for multiple collection cycles to achieve the necessary HSC yields. For some, gene therapy may be prohibitive by the failure to obtain adequate numbers of HSCs.

"The recent FDA approvals of two gene therapies for sickle cell disease in the U.S. is an exciting development for the sickle cell community," said Ella Sorani, PhD, Chief Development Officer at BioLineRx. "Through this new trial with St. Jude, and our ongoing collaboration with investigators at Washington University School of Medicine in St. Louis, we are excited to be working with leaders in gene therapy and stem cell mobilization to evaluate potential new mobilization options for patients with SCD."

Enrollment in the St. Jude Children's Research Hospital, Inc. study is expected to begin in the next few months. Initial data from the Washington University School of Medicine in St. Louis sponsored clinical trial (ClinicalTrials.gov Identifier: NCT05618301) is anticipated in the second half of 2024.

Motixafortide, BioLineRx's lead therapeutic candidate, was approved by the U.S. Food & Drug Administration (FDA) in September 2023, in combination with filgrastim (G-CSF), to mobilize HSCs for collection and subsequent autologous transplantation in patients with multiple myeloma, under the brand name APHEXDA®.

About SCDSTEMM Clinical Trial with St. Jude Children's Research Hospital Inc.

The SCDSTEMM (Sickle Cell Disease Stem Cell Mobilization and Apheresis Using Motixafortide) Phase 1 clinical trial is an open-label, multi-center study evaluating the safety, tolerability, and feasibility of single-agent motixafortide (CXCR4 inhibitor) for the mobilization and collection of CD34+ HSCs in 12 patients (aged 18 and older) with SCD. The trial's primary objective is to assess the safety and tolerability of motixafortide in SCD patients, as determined by the incidence of adverse events. Secondary objectives include understanding CD34+ kinetics after motixafortide administration in patients with SCD and determining the number of CD34+ HSCs collected via leukapheresis. The study is designed in two parts: Part A (N=6) will evaluate single dose motixafortide mobilization followed by one apheresis session; Part B (N=6) will evaluate daily motixafortide administration over a two-day mobilization and apheresis regimen. Additional objectives include phenotype and cell function characterization, as well as assessment of the gene modifying potential and senescence of CD34+ cells.

About Sickle Cell Disease

SCD is one of the most common genetic diseases globally, affecting millions of people throughout the world and disproportionately impacting persons of color. SCD arises from mutations in the hemoglobin gene, ultimately leading to the production of abnormally shaped (sickle) red blood cells. The clinical manifestations of SCD include anemia and blood vessel occlusion which can lead to both acute and chronic pain, as well as tissue ischemia across multiple organ systems (e.g., brain, lungs, heart, kidneys, spleen, liver, bones), ultimately compromising end organ function. The cumulative impact of these complications significantly impacts morbidity and mortality for patients with SCD.

MediWound Reports First Quarter 2024 Financial Results and Provides Company Update

https://finance.yahoo.com/news/mediwound-reports-first-quarter-2024-110000127.html

NexoBrid® interest surges; $5 million in Q1 2024 revenue, with $24 million forecast for the year

Manufacturing facility on target for completion by mid-2024

EscharEx® Phase III study to launch 2H 2024

Company set to join Russell 3000® Index

Conference call today, May 29 at 8:30am Eastern Time

YAVNE, Israel, May 29, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update.

"During the first quarter we maintained a laser-focused approach to executing our strategic plan. At the beginning of the year, we set three major goals: accelerate the revenue growth of NexoBrid®, complete construction of the new manufacturing facility by mid-year, and initiate the EscharEx® Phase III clinical trial in the second half of 2024, for which we have established collaborations with the most prominent wound care companies. I am pleased with our progress, as we are on track to achieve all of our targets," said Ofer Gonen, Chief Executive Officer of MediWound.

First Quarter 2024 Highlights, Recent Developments and Upcoming Milestones:

NexoBrid®

U.S. launch by Vericel continued to progress. More than 60 burn centers completed submissions to Pharmacy and Therapeutics (P&T) committees, approximately 40 centers obtained approval, and more than 30 centers have placed initial product orders. Vericel noted significant increases in the number of patients treated with NexoBrid and the number of NexoBrid orders by both burn centers and hospitals.

Construction of our new GMP-compliant, state-of-the-art manufacturing facility is on track to be completed by mid-2024, with commissioning set to begin in the third quarter of the year. The facility is expected to be fully operational in 2025, increasing the Company's manufacturing capacity sixfold.

Supplemental BLA for pediatric indication accepted for review by the U.S. Food and Drug Administration (FDA). Decision expected in the second half of 2024.

Development of the NexoBrid temperature-stable formulation for use as a non-surgical solution for field-care burn treatment for the U.S. Army is progressing as planned. FDA feedback on the development path is expected in the second half of 2024.

Enrollment and 12-month follow-up for the Expanded Access Treatment Protocol (NEXT) have been concluded: 239 burn patients have been treated across 29 U.S. centers. Data readout is anticipated in the second half of 2024.

EscharEx®

Phase III trial remains on track for final protocol submission in the first half of 2024. The global study aims to enroll 216 patients across 40 sites to be treated with either EscharEx or a gel vehicle placebo. An interim assessment will be performed once 67% of participants complete the trial. The study is expected to commence in the second half of 2024.

Recent Phase II data, which included comparative analyses demonstrating EscharEx’s superiority over SANTYL®, were presented at three prominent annual wound care conferences: the Wound Healing Society (WHS), the Symposium on Advanced Wound Care (SAWC), and the European Wound Management Association (EWMA).

Corporate Developments

Company included in the preliminary list of the Russell 3000® Index, as part of the 2024 Russell indexes annual reconstitution.

First Quarter 2024 Financial Highlights

Revenue: Revenue for the first quarter of 2024 was $5.0 million, compared to $3.8 million in the first quarter of 2023. The increase is primarily attributed to revenue from Vericel and new contracts with the U.S. Department of Defense (DoD).

Gross Profit: Gross profit in the first quarter of 2024 was $0.6 million, representing 12.2% of total revenue, compared to $0.8 million, representing 21.7% of total revenue in the first quarter of 2023. The decrease in gross margin is primarily due to changes in the revenue mix.

Expenditures:

Research and Development: R&D expenses in the first quarter of 2024 were $1.5 million, compared to $2.1 million in the first quarter of 2023. This decrease is primarily due to the completion of the EscharEx Phase II study.

Selling, General, and Administrative: SG&A expenses in the first quarter of 2024 were $2.9 million, compared to $3.1 million in the first quarter of 2023.

Operating Results: Operating loss in the first quarter of 2024 was $3.7 million, compared to an operating loss of $4.4 million in the first quarter of 2023.

Net Loss: Net loss in the first quarter of 2024 was $9.7 million, or $1.05 per share, compared to a net loss of $3.7 million, or $0.44 per share, in the first quarter of 2023. The increase in net loss is primarily due to financial expenses from revaluation of warrants, amounting to $6.1 million, driven by 40% increase in the Company's share price.

Non-GAAP Adjusted EBITDA: Adjusted EBITDA for the first quarter of 2024 was a loss of $2.9 million, compared to a loss of $3.4 million in the first quarter of 2023.

Balance Sheet Highlights

As of March 31, 2024, the Company had cash and cash equivalents, restricted cash, and deposits totaling $36.0 million, compared to $42.1 million as of December 31, 2023. During the first quarter of 2024, the Company received $0.5 million from the exercise of Series A warrants. The Company utilized $6.5 million to fund its activities in the first quarter of 2024, of which $2.7 million was invested in CAPEX related to the facility scale-up.

Conference Call
MediWound management will host a conference call for investors on Wednesday, May 29, 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.

Non-IFRS Financial Measures

To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company’s performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.

Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management.

However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company’s operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.

Independent Scientists Published a Review Article Demonstrating That Can-Fite Drugs Have Therapeutic Effects on Heart Diseases

https://finance.yahoo.com/news/independent-scientists-published-review-article-110000148.html

RAMAT-GAN, Israel, May 29, 2024--(BUSINESS WIRE)--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 reported that the International Journal of Molecular Sciences published a scientific review by independent scientists summarizing >50 publications from scientists all over the world stating that piclidenoson and namodenoson have a positive effect on heart diseases (Link to article).

According to the review, both piclidenoson and namodenoson induced in pre-clinical in vivo studies beneficial outcomes in cardiac ischemia, protection against ischemic/reperfusion injury, reduction in infarct size, improved contractile function against ischemic preconditioning, attenuation of cardiac hypertrophy, fibrosis, and myocardial dysfunction and more.

Can-Fite CSO & Executive Chairperson, Dr. Pnina Fishman commented on these findings, stating, "It is very interesting that our drug candidates have additional well-defined cardio-protective effect and have the potential to positively influence a broad range of heart diseases. In fact, we believe now that this is part of the mechanism contributing to the very good safety profile that has been observed all along the clinical development in more than 1600 patients suffering from psoriasis, liver cancer and MASH".

Can-Fite continues with its efforts to commence a Phase 3 clinical study in psoriasis, continues to enroll patients in a Phase 3 clinical study in advanced liver cancer as well asa Phase 2b study in MASH while additionally planning to start enrolment for a Phase 2a clinical study in pancreatic cancer in the near term.

BioLineRx Ltd. (BLRX) Q1 2024 Earnings Call Transcript

May 28, 2024 5:56 PM ETBioLineRx Ltd. (BLRX) Stock1 Comment

Q1: 2024-05-28 Earnings Summary

EPS of $0.00 beats by $0.29 | Revenue of $6.86M beats by $6.52M

BioLineRx Ltd. (NASDAQ:BLRX) Q1 2024 Earnings Call Transcript May 28, 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

Conference Call Participants

Joe Pantginis - HC Wainwright
John Vandermosten - Zacks

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2024 Financial Results Conference Call. All participants are presently in a listen-only mode. Following management's formal presentation, instructions will be given for the question-and-answer session. I would now like to turn over the call 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 first 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 US Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Phil Serlin

Thank you, John, and good morning, everyone, and thank you for joining us on today's call. Joining me today are 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.

I will begin with a brief update on the significant progress that we are making on our APHEXDA launch, then turn the call over to Holly who will go into our commercialization progress in more detail. I will then provide an update on our very promising pancreatic cancer and sickle cell disease programs. Finally, Mali will review our financial results. We will then open up the call to your questions.

Let me begin with an APHEXDA commercialization update. As we've noted previously, transplant centers, the end users of APHEXDA are a well-defined group in the US. Approximately 80 of the 212 centers in the US perform roughly 85% of all transplant procedures. In this foundational year for APHEXDA, we focused our efforts on these top centers and are making strong progress. To date, we have established formulary placement at centers that manage approximately 26% of all multiple myeloma-related transplant procedures in the top 80 centers, up from 20% last quarter. Importantly, we remain on track to achieve our 35% target by the end of the second quarter and 60% by the end of this year. As a result of this work, we saw steady growth in adoption in this, the first full quarter since launch. While it is very early in the launch, we are nonetheless pleased, not only with the sales trajectory that we are on, but on the progress that we continue to make, getting APHEXDA on more transplant center, formularies and treatment protocols.

Furthermore, feedback from transplant centers on the clinical benefits has been positive. They are experiencing APHEXDA's value firsthand, which simply put is greater certainty, greater certainty in collection, time to collection and scheduling. This is a new era for multiple myeloma patients and transplant centers. Patients are more often older and increasingly received quad induction therapy, which can increase mobilization risk. Additionally, transplant centers are seeing increased competition for APHEXDA chair time while experiencing staffing challenges. Greater certainty is the innovation that APHEXDA is providing this new era, and it is having a positive impact on patients as well as nursing and technical staffing. Our team is excited to be introducing a new standard of care for the mobilization of stem cells for multiple myeloma patients.

Staying on the topic of stem cell mobilization, recall that last October, we closed an exclusive license agreement with Gloria Biosciences for the development and commercialization of motixafortide across all indication locations in Asia. Gloria's IND for a small stem cell mobilization bridging study, a requirement for commercialization approval in China was recently accepted by the Center for Drug Evaluation of the National Medical Products Administration in China. We expect that this study will commence with the first patient dosed in the second half of this year. Additionally, for countries in Asia that do not require a bridging study, Gloria is making great progress. We anticipate commercialization to begin in the Bao region of China, in Singapore and in Macau over the next few quarters. We estimate that Asia had over 51,000 reported cases of multiple myeloma, the largest number of cases globally. Stem cell mobilization is, therefore, a significant opportunity for both companies in the region.

At this point, I'd like to turn the call over to Holly May, President of BioLineRx US, for a more detailed review of our early APHEXDA commercialization progress. Holly, please go ahead.

Holly May

Thank you, Phil. As mentioned, this is a new era for patients with multiple myeloma planning for a stem cell transplant. Patients are receiving transplants at increased age, and in the US, they are now often treated with quadruplet induction therapy which leads to the highest rate of complete responses and prolonged progression-free survival. These are both great achievements with strong benefits for patients. However, increased age and the combination of drugs used in quad therapy are both known to contribute to poor stem cell mobilization.

As a result, the number of patients categorized as predicted poor mobilizers is increasing. This outcome is impacting in real time, long-held mobilization treatment paradigm set centers. This quarter, we presented two posters that highlighted the innovation benefits of APHEXDA on center efficiency and economics. This data, which was presented at the American Society for Apheresis Annual Meeting, or ASFA, and at the International Society for Pharmacoeconomics and Outcomes Research, or ISPOR, is supporting decision-makers at centers as they consider new mobilization strategies. Results from the analysis presented at ASPA, which assumed an institution averaging 20 transplants per month showed that switching to GCSF plus APHEXDA could increase apheresis capacity by 52 patient days per month versus GCSF alone or by 12.3 patient days per month versus GCSF in combination with plerixafor. Additionally, the analysis presented at ISPOR showed that even with APHEXDA's higher drug costs compared to other mobilization regimens, specifically GCSF alone or GCSF plus generic plerixafor, the combination of GCSF plus APHEXDA may confer a similar or better overall financial impact.

Early adopting centers understand how this efficiency can offer a better economic outcome to them and to the health care system overall. They are also seeing the tangible value that APHEXDA is bringing to their patients, and this knowledge is being shared peer-to-peer at other transplant centers. Like any newly launched drug in a hospital setting where there can be a longer ramp-up cycle, APHEXDA is in its foundational period. Our commercial team is making strong and steady progress with centers. And as a result, we continue to see APHEXDA added to the formularies at the top centers, and we predict continued growth. In summary, I'm very pleased with our momentum since launch and the powerful methods of innovation, efficiency and value that we are able to convey to patients, physicians and transplant center leaders.

Now, let me turn the call back over to Phil.

Phil Serlin

Thank you, Holly. Turning now to our second development indication for motixafortide pancreatic cancer. Our randomized Phase 2 study collaboration in first-line pancreatic cancer sponsored by Columbia University and supported equally by BioLineRx and Regeneron is actively enrolling. Data from the 11-patient pilot phase of this trial known as CheMo4METPANC continues to show encouraging findings. We recently announced new data from an abstract accepted at this week's American Society of Clinical Oncology, or ASCO’s 2024 Annual Meeting. The new analysis of paired pre- and on-treatment biopsy samples demonstrated a significant increase in CD8-positive T-cell density in tumors from all 11 patients treated with the combination of motixafortide PD-1 inhibitor zimberelimab and standard of care chemotherapy, gemcitabine and nab-paclitaxel with a p-value of less than 0.007.

These biopsy sample fundings continue to confirm immune cell activation and tumor microenvironment modulation initially observed in the earlier COMBAT Phase 2a clinical trial. PD-1 immunotherapies have previously shown limited to no efficacy in pancreatic cancer, we believe that motixafortide can alter tumor resistance in pancreatic cancer and potentially other solid tumor types, helping to overcome a significant obstacle for immunotherapies, including PD-1s.

In addition to the chemo for METPANC trial as part of our license agreement with Gloria Biosciences, we are working with them on the design of an additional randomized Phase 2b clinical trial, evaluating motixafortide in combination with Gloria's commercial PD-1 inhibitor, zimberelimab, a standard of care combination chemotherapy in first-line pancreatic cancer. That trial in China is expected to commence in the first half of 2025. In summary, we believe the combination potential of motixafortide and PD-1 inhibitors in pancreatic cancer as well as over 20 other solid tumor types with high levels of CXCR4 expression could be a significant multibillion-dollar opportunity.

Turning now to sickle cell disease. We are also making great progress pursuing motixafortide’s potential to support gene therapy for patients with sickle cell disease, which requires significant quantities of hematopoietic stem cells for genetic manipulation, manufacturing and transplant success. The most commonly used drug for collection of stem cells, G-CSF is contraindicated patients with sickle cell disease and the current strategy using celrixafor has shown limitations, including the need for multiple collection cycles to achieve the necessary hematopoietic stem cell yields. For some, gene therapy may be prohibitive by the failure to obtain adequate numbers of hematopoietic stem cells.

We are actively working with leaders in the gene therapy field and look forward to the second half of this year when the early data is expected from our collaboration with Washington University School of Medicine in St. Louis, which is evaluating motixafortide for the mobilization of hematopoietic stem cells in patients with sickle cell disease in the Phase 1 clinical trial.

At this point, I'd now like to turn the call over to Mali, who will review our financials. Mali, please go ahead.

Mali Zeevi

Thank you, Phil. 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 loss and cash. I invite you to review the 6-K filing we made this morning that contains our financials and press release. The revenues for the quarter ended March 31, 2024, were $6.9 million. We did not record any revenues during the first quarter of 2023.

Revenues for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license agreement and the milestone payment achieved under same license agreement, which collectively amounted to $5.9 million as well as $0.9 million of net revenues from product sales of APHEXDA in the US. Cost of revenues for the quarter ended March 31, 2024, was $1.5 million. We did not record any cost of revenues during the first quarter of 2023. The cost of revenues for the quarter primarily reflect sublicense fees on a milestone payment received under the Gloria Biosciences license agreement and royalties on net product sales of APHEXDA in the U, as well as amortization of intangible assets and cost of goods sold on product sales.

Research and development expenses for the quarter ended March 31, 2024, were $2.5 million as compared to $3.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide supporting activities as well as termination of the development of AGI-134.

Sales and marketing expenses for the quarter ended March 31, 2024, were $6.3 million as compared to $3.9 million for the same period in 2023. The increase resulted primarily from the ramp-up of commercialization activities related to motixafortide, including headcount costs associated with fully hired field teams.

Net loss for the quarter ended March 31, 2024, was $0.7 million compared to $12.2 million for the same period in 2023. The net loss for the 2024 period included $4.5 million in non-cash income compared to nonoperating expenses of $2.9 million for the same period in 2023, both specifically related to the revaluation of warrants.

As of March 31, 2024, the company had cash, cash equivalents and short-term bank deposits of $28.2 million. Subsequent to the end of the quarter, we accessed an additional $20 million in non-dilutive debt financing under our previously announced agreement with BlackRock, formerly Quellos Capital. We also completed a $6 million registered direct equity offering. We anticipate that this amount will be sufficient to fund operations as currently planned into 2025.

And with that, I'll turn the call back 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. The first is continued commercialization ramp-up of APHEXDA in the US. Next, initiation of a bridging study by Gloria Biosciences to support approval of APHEXDA in stem-cell mobilization for multiple myeloma in China. Then completion of recruitment in the Phase 1 pilot study of motixafortide for gene therapies and sickle cell disease led by Washington University School of Medicine, with initial data expected in the second half of this year. Also continued recruitment in the chemo for METPANC Phase 2b randomized clinical trial in first-line metastatic pancreatic cancer sponsored by Columbia University and supported by BioLineRx and Regeneron. And lastly, preparation activities with Gloria Biosciences on a Phase 2b combination study evaluating motixafortide in first-line pancreatic cancer.

With that, we have now concluded the formal part of our presentation. Operator, we will be happy now to open the call to questions.

Question-and-Answer Session

Operator

[Operator Instructions] The first question is from Joe Pantginis of HC Wainwright. Please go ahead.

Joe Pantginis

Hey everybody, good morning and good afternoon. Thanks for taking the questions. Very nice to hear all the early factors contributing to the potential strong launch of APHEXDA. So a couple of questions there, if you don't mind. So first, I realize, obviously, there, ahead of time, there might be a lot of noise around your answers here because it's still early in the launch. But first off, Phil, you mentioned a few different things, but I guess for you and Holly, what would you say are the top one or two early factors that centers are seeing are truly differentiated even if it's as simple as access to chairs quicker?

Phil Serlin

Okay. First of all, Joe, good morning. It's a pleasure to hear your voice. I think this one, I will turn it over to Holly. Holly, can you take this?

Holly May

Yes. Yeah. Thanks, Phil, and thank you, Joe, for the question. So certainly, it's the chair time. We've -- and I think as I spoke in my comments, we had two very interesting posters that talk about the efficiencies that institutions can see using APHEXDA plus G-CSF over whatever their standard mobilization regimen was. But I think the other thing, and I know we've talked in this forum before about the three legs or the three pillars of our value proposition. I think one of the things that is resonating with every center is the clinical benefit, and that is the increased number of CD34 stem cells mobilized in a single apheresis. So the rest of the story is certainly what that means to center, increased efficiencies, chair time, et cetera. But I think the thing that unequivocally resonates across all of the institutions that are using APHEXDA is the number of stem cells that are being able to be harvested in a single session. Exactly what we saw it in Phase 3 data, which is very encouraging. Did that answer the question?

Operator

The next question is from John Vandermosten of Zacks. Please go ahead.

John Vandermosten

Thank you. So let me go on some of the questions about just the APHEXDA rollout. And based on your observations of the formulary committee meetings, are they bunched up around certain parts of the year? I mean, maybe the end of the semester for academic institutions or just at the end of the quarter, when you see a lot of those come through. Can you give me any color on that?

Phil Serlin

Yeah, sure. Hi, John, first of all, thanks for dialing in. Holly, do you want to take that?

Holly May

Yeah, sure. Thanks. Thanks, John, for your question. No, not really. There is no kind of phasing by quarter or by year. Most institutions have P&T committee meetings on a monthly basis. So there is a little bit of kind of stickiness on the up-ramp in that. We need to talk to the P&T members get on the schedule for P&T. After P&T approval -- after the approval of that committee, then there are protocols that need to be in place and then order sets. So it is a little bit of a longer ramp-up but to say that these P&T meetings where these decisions are being made happen at a phasing of end of a quarter under the year, that's not necessarily a true statement. They happen every month. And so our field teams are hard at work center by center to get them the information that they need in order to move forward with those P&T committee meetings and hopefully, positive decisions.

John Vandermosten

Okay. And so I guess that suggests that you'd see a steady increase in penetration as we move towards your target for the end of the year?

Phil Serlin

I think that, that's a correct statement. Yes, John.

John Vandermosten

Great. And there are -- I think I calculated spots tracking that are there about 132 transplant centers that aren't in your target group. Have any of those picked up the use of APHEXDA? And how do you anticipate those other centers, I guess, [indiscernible] centers. And how do you anticipate those actually picking up the product? I mean, maybe by physicians that used it in one of the primary centers, kind of taking it with them or just recognizing the value. How do you see those other guys that you aren't really targeting directly using the product as we move through the quarters?

Phil Serlin

Holly, did you get that?

Holly May

Yeah, I did. So I'm happy to answer that question. So first of all, as I think we've stated before, the 86% of all transplants in multiple myeloma occur in those 80 centers. So your math is pretty good there. Those -- the extended effort that would need to occur in order to get that additional 14% isn't necessarily efficient, especially for a small company like BioLine that's very much focused on those top 80 centers. The other thing that we haven't necessarily talked about is that we also are looking at those institutions that use a booster agent [indiscernible] like APHEXDA. And many of those institutions that you're speaking of in that additional 14% still aren't necessarily using a boosting agent to the rate that those top 80 are. So there's many reasons why we are hyper focused on those top 80. That's not to say that eventually, as we move through the process that there isn't value in that remaining -- those remaining institutions, but it will just take a lot more effort from our field teams in order to gain those. So in the first year, we are very much focused on where we can make the greatest impact as quickly as we can.

John Vandermosten

Okay. That's helpful. And another question on the gene therapy side, again, I know I was asking this. But, Phil, you and I have talked in the past and, Holly too, maybe, on just how part of the goal of the current trial that's going on in Washington University is to establish safety. I guess after you achieve that and the data is made available, do you anticipate that there will be a lot of demand in gene therapy clinical trials for the use of your product? I mean do you see that, that is something that maybe other studies are looking at and kind of waiting to kind of get the validation from the sickle cell trial to kind of use it themselves?

Phil Serlin

Yeah. So, John, that's a really good question. And I can also ask perhaps Holly and Ella to chime in as well. But we are actively speaking with a number of potential collaboration of partners both in the industry as well as at academic institutions. And so we certainly do believe -- we certainly do see in the future additional clinical trials in this area. Does that answer your question? Or do you want any additional information?

John Vandermosten

No, that's helpful. And unless you have anything else that elaborate on that. I do have one more on the finance side. I mean, that doesn't answer it. I didn't want to leave Mali out as looking at gross margin, and I wanted to see if there's any guidance you could give us in terms of trying to estimate that as we move through the year based on our forecast for product sales.

Phil Serlin

Yeah. So I mean, I think that you can see in our financial statements that gross margins are well in excess of 90% and significantly in excess of 90%. And I don't think that, that's going to change.

John Vandermosten

Okay. All right. Thank you for taking my questions.

Phil Serlin

You’re welcome. Have a great day.

Operator

The next question is from Joe Pantginis of HC Wainwright. Please go ahead.

Joe Pantginis

Hey there. Thanks for taking the follow up. I just wanted to ask -- look, I don't want to overstate or understate, but I really wanted to get your comments as to the potential importance of the work that you did ahead of time to be able to get the pass-through status for CMS with regard to hospital bundling? And then second, anything that we need to consider with regard to drug supply and manufacturing efforts for additional ramp-up? Thank you.

Phil Serlin

Okay. So I will turn that first question over to Holly, and I'll take the second question. Go ahead, Holly.

Holly May

I don't know if I heard the question in there, but I will attempt to answer this, and if I didn't -- if I didn't clearly get to your concern, please ask the question again. So we are quite pleased with the work that our account team has done. We have three different types of field individuals. We have our sales professionals. We have our medical team and then we also have our account payer team. And they are focused on the payers, both commercial and government payers to assure that we have access. And we are quite pleased where we are right now with about 95% of the lives covered. And as you said also, we are -- in the first quarter, we have a team that pass-through status. So we feel like we are well positioned, and we have not, to date, had any issues with any sort of access or denial of patients to receive APHEXDA. Now, did I answer your question? I'm not exactly sure.

Joe Pantginis

You did, Holly. You did. Thank you.

Phil Serlin

And on the supply side, Joe, we are very well positioned from a drug supply perspective, both for all of our commercial needs as well as our clinical needs. So there's really no issue there whatsoever.

Joe Pantginis

Great. Thanks for the follow-up.

Phil Serlin

You’re welcome.

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 US, please call 1 (888) 295-2634. In Israel, please call 03-925-5904. Internationally, please call 972-3-925-5904. Mr. Serlin, would you like to make your concluding statement?

Phil Serlin

Yes. Thank you, operator. In closing, we are progressing through 2024 with significant momentum both with the ongoing commercial ramp of APHEXDA as well as the advancement of our development programs in pancreatic cancer and sickle cell disease. I'm excited for what we are poised to accomplish over the remainder of this 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 August. Be safe, and have a great day.

Operator

Thank you. This concludes the BioLineRx first quarter 2024 conference call. Thank you for your participation. You may go ahead and disconnect.

biolinerx GAAP EPS of $0.00 beats by $0.29, revenue of $6.86M beats by $6.52M

May 28, 2024 7:03 AM ETBioLineRx Ltd. (BLRX) Stock

By: Meghavi Singh, SA News Editor

biolinerx press release (NASDAQ:BLRX): Q1 GAAP EPS of $0.00 beats by $0.29.

Revenue of $6.86M beats by $6.52M. The company did not record any revenue during the first quarter of 2023.

As of March 31, 2024, the company had cash, cash equivalents, and short-term bank deposits of $28.2 million.

The company anticipates that this amount will be sufficient to fund operations, as currently planned, into 2025.

BioLineRx Reports First Quarter 2024 Financial Results and Recent Corporate and Portfolio Updates

https://finance.yahoo.com/news/biolinerx-reports-first-quarter-2024-110000391.html

- Among top 80 transplant centers, secured APHEXDA formulary placement to date at institutions representing ~26% of stem cell transplant procedures performed - on track to reach stated goal of ~35% by end of Q2 -

- Announced new data in abstract accepted at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on pilot phase of ongoing Phase 2b pancreatic cancer clinical trial collaboration with Columbia University -

- Collaboration partner Gloria Biosciences' motixafortide HSC mobilization bridging study IND was filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate clinical trial initiation 2H 2024 -

- Completed debt and equity financing totaling $26 million to support U.S. commercialization of APHEXDA and advance lifecycle expansion activities -

- Management to host conference call today, May 28, at 8:30 am EDT -

TEL AVIV, Israel, May 28, 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 first quarter ended March 31, 2024, and provided recent corporate and portfolio updates.

"In this first full quarter post APHEXDA® approval, we were pleased by the steady growth in adoption and repeat purchases by transplant centers, which is consistent with our expectations during this foundational period," said Philip Serlin, Chief Executive Officer of BioLineRx. "This growth comes as we see continued increases in the number of transplant centers that have completed Pharmacy & Therapeutics committee reviews and granted approval for APHEXDA usage. As a reminder, end users of APHEXDA are well defined, with 80 of the 212 U.S. transplant centers performing approximately 85% of all transplant procedures. Importantly, among these top 80 transplant centers, we've secured formulary placement to date at institutions representing ~26% of stem cell transplant procedures performed, keeping us on track to reach our stated goal of 35% by the end of Q2.

"In our major pipeline program in pancreatic cancer, we continue to see strong data emerge from the pilot phase of the Phase 2 PDAC trial sponsored by Columbia University. Last week we announced new data in an accepted ASCO abstract on paired pre- and on-treatment biopsy data that show a significant increase in CD8+ T-cell density in tumors from all 11 patients treated—further reinforcing our belief in the potential of the combination of motixafortide with a PD-1 inhibitor to treat this very challenging cancer with substantial unmet need.

"Finally, we are also making great progress pursuing motixafortide's potential to support gene therapy for patients with sickle cell disease, which requires significant quantities of hematopoietic stem cells. This is an important growth program, and we are actively working with a number of leaders in the gene therapy field, while looking forward to the second half of this year when early data from our collaboration with Washington University in St. Louis is expected."

Corporate Updates

Accessed $20 million in non-dilutive debt financing from previously announced agreement with BlackRock EMEA Venture and Growth Lending (previously Kreos Capital) and completed a $6 million registered direct equity offering. Funds will be used to support ongoing commercialization of APHEXDA in the U.S. and to advance lifecycle expansion activities

Strengthened motixafortide intellectual property estate with notice of allowance for U.S. patent covering method of manufacturing motixafortide suitable for large scale production; the patent supplements existing protections offered by Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as Orphan Drug market exclusivity for autologous stem cell mobilization in multiple myeloma patients in the U.S. following last year's FDA approval of APHEXDA

APHEXDA Launch Updates

Among top 80 transplant centers, secured formulary placement to date at institutions representing ~26% of stem cell transplant procedures performed – on track to reach stated goal of ~35% by end of Q2 and ~60% by year-end 2024

Granted "pass through" status from the Centers for Medicare and Medicaid Services (CMS), ensuring that reimbursement for APHEXDA for Medicare and certain commercial payers will be separate from payment bundling methodologies when administered in the hospital outpatient setting

Clinical Portfolio Updates

Motixafortide (selective inhibitor of CXCR4 chemokine receptor)

Multiple Myeloma

Presented posters at both the American Society for Apheresis 2024 Annual Meeting on April 17, 2024, and the International Society for Pharmacoeconomics and Outcomes Research on April 6, 2024. The posters reviewed apheresis center efficiency between CXCR4 antagonists, including APHEXDA, in patients with multiple myeloma, as well as economic model data on APHEXDA for HSC mobilization in patients with multiple myeloma

Collaboration partner Gloria Biosciences' stem cell mobilization bridging study IND 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

Pancreatic Ductal Adenocarcinoma (mPDAC)

Announced new data in an abstract accepted at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on the pilot phase of the ongoing CheMo4METPANC Phase 2 clinical trial collaboration with Columbia University, including new analysis of paired pre- and on-treatment biopsy samples. The presentation will be held on June 1, 2024 in Chicago, IL

Announced first patient dosed in the randomized CheMo4METPANC Phase 2 clinical trial, an expansion of the pilot phase single-arm study, evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in 108 patients with metastatic pancreatic cancer

Advanced plans with collaboration partner Gloria Biosciences on a Phase 2b randomized clinical trial in China assessing 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

Sickle Cell Disease (SCD) & Gene Therapy

Continued to enroll patients into a clinical trial in collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. Anticipate initial data in 2H 2024

First Quarter 2024 Financial Results

Total revenue for the first three months ended March 31, 2024 was $6.9 million. The Company did not record any revenue during the first quarter of 2023. Revenue for the quarter reflect a portion of the upfront payment from the Gloria Biosciences license agreement and a milestone payment achieved under the same license agreement, which collectively amounted to $5.9 million, as well as $0.9 million of net revenue from product sales of APHEXDA in the U.S.

Cost of revenue for the first three months ended March 31, 2024 was $1.5 million. The Company did not record any cost of revenue during the first quarter of 2023. The cost of revenue for the quarter primarily reflects sub-license fees on a milestone payment received under the Gloria Biosciences license agreement and royalties on net product sales of APHEXDA in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales

Research and development expenses for the first three months ended March 31, 2024 were $2.5 million, compared to $3.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide New Drug Application (NDA) supporting activities, as well as termination of the development of AGI-134

Sales and marketing expenses for the first three months ended March 31, 2024 were $6.3 million, compared to $3.9 million for the same period in 2023. The increase resulted primarily from the ramp-up of commercialization activities related to motixafortide, including headcount costs associated with fully hired field team

General and administrative expenses for the first three months ended March 31, 2024 were $1.4 million, compared to $1.3 million for the same period in 2023. The increase resulted primarily from a small increase in share-based compensation

Non-operating income for the first three months ended March 31, 2024 was $4.5 million, compared to non-operating expenses of $2.9 million for the same period in 2023. Non-operating expenses and income primarily relate to the non-cash revaluation of outstanding warrants resulting from changes in the Company's share price during the respective periods

Net loss for the first three months ended March 31, 2024 was $0.7 million, compared to $12.2 million for the same period in 2023. The net loss for the 2024 period included $4.5 million in non-cash income, compared to non-operating expenses of $2.9 million for the same period in 2023, both specifically related to the revaluation of warrants

As of March 31, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $28.2 million. This amount does not include $6.0 million in gross proceeds received from a registered direct offering and a $20.0 million drawdown of the second tranche from the existing loan agreement with BlackRock, which were both completed in April 2024. 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 May 30, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

About BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.

Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.

Forward Looking Statement

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether BioLineRx's collaboration partners will be able to execute on collaboration goals in a timely manner; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, operationalize and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic, the Russian invasion of Ukraine, the declared war by Israel against Hamas and the military campaigns against Hamas and other terrorist organizations, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 26, 2024. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contacts:

United States
John Lacey
BioLineRx
IR@biolinerx.com

Israel
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com





BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(UNAUDITED)





December 31,

March 31,



2023

2024



in USD thousands

Assets





CURRENT ASSETS





Cash and cash equivalents

4,255

5,990

Short-term bank deposits

38,739

22,183

Trade receivables

358

2,832

Prepaid expenses

1,048

1,290

Other receivables

830

507

Inventory

1,953

2,889

Total current assets

47,183

35,691







NON-CURRENT ASSETS





Property and equipment, net

473

411

Right-of-use assets, net

1,415

1,308

Intangible assets, net

14,854

14,190

Total non-current assets

16,742

15,909

Total assets

63,925

51,600







Liabilities and equity





CURRENT LIABILITIES





Current maturities of long-term loan

3,145

3,680

Contract liabilities

12,957

9,027

Accounts payable and accruals:





Trade

10,869

8,256

Other

3,353

2,455

Current maturities of lease liabilities

528

467

Warrants

11,932

7,488

Total current liabilities

42,784

31,373







NON-CURRENT LIABILITIES





Long-term loan, net of current maturities

6,628

5,938

Lease liabilities

1,290

1,229

Total non-current liabilities

7,918

7,167

COMMITMENTS AND CONTINGENT LIABILITIES





Total liabilities

50,702

38,540







EQUITY





Ordinary shares

31,355

31,355

Share premium

355,482

355,482

Warrants

1,408

1,408

Capital reserve

17,000

17,533

Other comprehensive loss

(1,416)

(1,416)

Accumulated deficit

(390,606)

(391,302)

Total equity

13,223

13,060

Total liabilities and equity

63,925

51,600





BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)





Three months ended March 31,



2023

2024



in USD thousands

REVENUES

-

6,855

COST OF REVENUES

-

(1,455)

GROSS PROFIT

-

5,400

RESEARCH AND DEVELOPMENT EXPENSES

(3,684)

(2,494)

SALES AND MARKETING EXPENSES

(3,874)

(6,342)

GENERAL AND ADMINISTRATIVE EXPENSES

(1,298)

(1,386)

OPERATING LOSS

(8,856)

(4,822)

NON-OPERATING INCOME (EXPENSES), NET

(2,916)

4,490

FINANCIAL INCOME

537

565

FINANCIAL EXPENSES

(927)

(929)

NET LOSS AND COMPREHENSIVE LOSS

(12,162)

(696)









in USD

LOSS PER ORDINARY SHARE - BASIC AND DILUTED

(0.01)

(0.00)







WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE

922,958,942

1,086,589,165











BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

(UNAUDITED)





Ordinary
shares

Share
premium

Warrants

Capital
reserve

Other
comprehensive
loss

Accumulated
deficit

Total



in USD thousands

BALANCE AT JANUARY 1, 2023

27,100

338,976

1,408

14,765

(1,416)

(329,992)

50,841

CHANGES FOR THREE MONTHS ENDED MARCH 31, 2023:















Employee stock options expired

-

66

-

(66)

-

-

-

Share-based compensation

-

-

-

435

-

-

435

Comprehensive loss for the period

-

-

-

-

-

(12,162)

(12,162)

BALANCE AT MARCH 31, 2023

27,100

339,042

1,408

15,134

(1,416)

(342,154)

39,114





















Ordinary
shares



Share
premium





Warrants



Capital
reserve

Other
comprehensive
loss



Accumulated
deficit





Total



in USD thousands

BALANCE AT JANUARY 1, 2024

31,355

355,482

1,408

17,000

(1,416)

(390,606)

13,223

CHANGES FOR THREE MONTHS ENDED MARCH 31, 2024:















Share-based compensation

-

-

-

533

-

-

533

Comprehensive loss for the period

-

-

-

-

-

(696)

(696)

BALANCE AT MARCH 31, 2024

31,355

355,482

1,408

17,533

(1,416)

(391,302)

13,060





















BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)





Three months ended

March 31,



2023

2024



in USD thousands







CASH FLOWS - OPERATING ACTIVITIES





Comprehensive loss for the period

(12,162)

(696)

Adjustments required to reflect net cash used in operating activities

(see appendix below)

4,146

(13,413)

Net cash used in operating activities

(8,016)

(14,109)







CASH FLOWS - INVESTING ACTIVITIES





Investments in short-term deposits

(5,500)

-

Maturities of short-term deposits

12,271

16,719

Purchase of property and equipment

(32)

(32)

Purchase of intangible assets

(97)

-

Net cash provided by investing activities

6,642

16,687







CASH FLOWS - FINANCING ACTIVITIES





Repayments of loan

-

(765)

Repayments of lease liabilities

(49)

(129)

Net cash used in financing activities

(49)

(894)







INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

(1,423)

1,684

CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD

10,587

4,255

EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

(98)

51

CASH AND CASH EQUIVALENTS - END OF PERIOD

9,066

5,990











BioLineRx Ltd.

APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)





Three months ended

March 31,



2023

2024



in USD thousands













Adjustments required to reflect net cash used in operating activities:





Income and expenses not involving cash flows:





Depreciation and amortization

259

897

Exchange differences on cash and cash equivalents

98

(51)

Fair value adjustments of warrants

3,040

(4,444)

Share-based compensation

435

533

Interest on short-term deposits

(497)

(163)

Interest on loan

630

610

Exchange differences on lease liabilities

(92)

(25)



3,873

(2,643)







Changes in operating asset and liability items:





Increase in trade receivables

-

(2,474)

Increase in inventory

-

(936)

Decrease (increase) in prepaid expenses and other receivables

(121)

81

Increase (decrease) in accounts payable and accruals

394

(3,511)

Decrease in contract liabilities

-

(3,930)



273

(10,770)



4,146

(13,413)



















Supplemental information on interest received in cash

276

357







Supplemental information on interest paid in cash

311

255







Changes in right-of-use asset and lease liabilities

66

32









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Can-Fite to Participate in Partnering Meetings at Bio International Convention 2024

https://finance.yahoo.com/news/fite-participate-partnering-meetings-bio-110000426.html

PETACH TIKVA, Israel, May 27, 2024--(BUSINESS WIRE)--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 announces that its VP of Business Development, Dr. Sari Fishman, will hold 23 partnering meetings with Biotech & Pharma companies, who showed interest in partnering with Can-Fite. The meetings will take place during the Bio International Convention 2024 in San Diego, USA, on June 3-6. https://convention.bio.org/registration?gad_source=1&gclid=Cj0KCQjwu8uyBhC6ARIsAKwBGpR1uawA2qpi9I2O3htc7bwxwiKsbpmP1IefbWC8KrkYc5njVnODEpYaAsWWEALw_wcB

Can-Fite currently has out-licensing and distribution deals with seven pharma companies across North America, Europe, and Asia, which include upfront and milestone payments. The Company’s growing slate of indications and advanced pipeline are attracting increased interest from additional potential partners that will attend the conference in San Diego. Focusing on its core expertise in clinical development, Can-Fite pursues a strategy of partnering with companies in specific geographic markets that specialize in pharmaceutical distribution and regional regulatory approval.

Can-Fite’s pipeline of indications includes the two small molecule orally bioavailable drugs, Piclidenoson positioned for the treatment of Psoriasis (Phase 3) and Namodenoson for the treatment of advance liver cancer (Phase 3), pancreatic cancer (Phase 2a) and MASH (Phase 2b).

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite’s cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.

Some casual sign of optimism towards
May 28th report , i wonder?
0.6850+0.0801(+13.24%)
At close: May 24 at 4:00 PM EDT

biolinerx Q1 Earnings Preview

May 24, 2024 1:44 PM ETBioLineRx Ltd. (BLRX) Stock

By: Pranav Ghumatkar, SA News Editor

biolinerx (NASDAQ:BLRX) is scheduled to announce Q1 earnings results on Tuesday, May 28th, before market open.

The consensus EPS Estimate is -$0.29 and the consensus Revenue Estimate is $0.34M.

BioLineRx Announces Abstract on Pilot Study Data from Phase 2 Combination Clinical Trial Evaluating Motixafortide in First-Line Pancreatic Cancer (PDAC) at American Society of Clinical Oncology (ASCO) 2024 Annual Meeting

https://finance.yahoo.com/news/biolinerx-announces-abstract-pilot-study-110000276.html

New analysis of biopsy samples demonstrated a significant increase in CD8+ T-cell density in tumors from all 11 patients treated

7 of 11 patients in the pilot phase experienced a partial response, with 6 confirmed; 10 of 11 patients experienced disease control

Poster Presentation on Saturday, June 1, 2024 in Chicago, Illinois

TEL AVIV, Israel, May 24, 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 an abstract including new data from the single-arm pilot phase of the investigator-initiated, randomized CheMo4METPANC Phase 2 combination clinical trial was accepted for presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31-June 4, 2024 in Chicago, Illinois. The CheMo4METPANC trial is evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard-of-care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).

Updated results of the pilot study portion of the Phase 2 study include a new analysis of paired pre- and on-treatment biopsy samples that demonstrated an increase in CD8+ T-cell density in tumors from all 11 patients treated with the combination of motixafortide, cemiplimab and standard-of-care chemotherapies gemcitabine and nab-paclitaxel (P = 0.007). As of February 6, 2024, 7 patients achieved partial response (64%), including 6 confirmed partial responses, and 10 patients (91%) had disease control compared to historic partial response and disease control rates of 23% and 48%, respectively, with gemcitabine and nab-paclitaxel. Preliminary median progression-free survival (PFS) was 9.6 months compared to historic median PFS of 5.5 months with gemcitabine and nab-paclitaxel.

"We continue to be encouraged by the data from the pilot phase of this ongoing Phase 2 study, including the initial efficacy results, as well as new findings that the combination therapy including motixafortide demonstrated increased CD8+ T-cell density in the tumors of all patients treated," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "The biopsy sample findings continue to confirm immune cell activation and tumor microenvironment modulation observed in previous clinical evaluation. We look forward to our continued collaboration with Columbia University on this clinical research, and to advancing a potential new therapeutic option for pancreatic cancer, which is urgently needed for this difficult-to-treat disease."

Based on the encouraging results from the pilot phase of the study, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 108 patients. Sponsored by Columbia University, the trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.

Poster Presentation at ASCO 2024
McCormick Place, Chicago, Illinois

Poster Session Details

Primary Track: Gastrointestinal Cancer—Gastroesophageal, Pancreatic and Hepatobiliary
Title: CheMo4METPANC: A randomized phase 2 study with combination chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) compared to chemotherapy alone in metastatic treatment-nai¨ve pancreatic adenocarcinoma
Presenter: Gulam Abbas Manji, MD, PhD, Columbia University Herbert Irving Comprehensive Cancer Center
Abstract: TPS4208 (see abstract)
Poster # 174a
Date: Saturday, June 1, 2024
Time: 1:30 PM CDT
Location: Hall A

About CheMo4METPANC Phase 2 Clinical Trial
The multi-center CheMo4METPANC Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04543071) is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, and supported equally by BioLineRx and Regeneron, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in 108 patients. The trial's primary endpoint is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.

About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2024, an estimated 66,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths.1 Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.2 In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC. These data highlight the need for the development of new therapeutic options.

About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.

Biomica Presents Positive Clinical Data Update from Ongoing Phase 1 Trial of Microbiome-Based Therapeutic, BMC128, for Refractory RCC, NSCLC & Melanoma

https://finance.yahoo.com/news/biomica-presents-positive-clinical-data-150000267.html

Preliminary Phase 1 results show promising trends for BMC128 in combination with nivolumab in refractory cancer patients. Data will be showcased at the 2024 American Society of Clinical Oncology (ASCO) annual meeting.

REHOVOT, Israel, May 23, 2024 /PRNewswire/ -- Biomica Ltd., a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), today announced encouraging initial findings from an ongoing Phase 1 clinical trial. In the study, Biomica is investigating the safety and tolerability of its microbiome-based immuno-oncology candidate, BMC128, in combination with nivolumab, an anti-PD1 immune checkpoint inhibitor, in patients with non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC).

All trial participants, 11 patients, had experienced disease progression in prior immunotherapy treatment before joining the trial. These preliminary findings represent some of the initial positive evidence emerging from the burgeoning field of clinical research on cancer therapies leveraging gut microbiota. While these results are preliminary and subject to further validation, they suggest potential benefits for patients facing advanced stages of these malignancies.

ASCO 2024 Presentation Details:

Title: Preliminary results from a First-in-Human (FIH), open-label Phase 1 study with BMC128, a rationally designed live bacterial consortium, in combination with nivolumab.
Session Type: Poster Session
Abstract Number: 8631
Date and Time: June 3, 2024, 1:30 PM – 4:30 PM (CDT)

Key observations from the study include:

Safety Profile: As of the data cutoff date, the safety profile of BMC128 has been exceptional, with no major safety events potentially associated with BMC128 reported during the course of BMC128 monotherapy or combination treatment, indicating a favorable safety profile for the investigational therapy.

Clinical Responses: As of the data cutoff date, among the patients included in the study, 72% of refractory cases exhibited positive clinical signals, indicating a potential efficacy for the BMC128 and nivolumab combination.

Response Rates: As of the data cutoff date, one patient demonstrated partial response (PR) upon imaging and RECIST v1.1 assessment and remains actively responding to treatment. Additionally, 64% of patients' disease stopped progressing following the combination treatment, and they displayed stable disease (SD) and sustained benefits beyond the first imaging assessment, suggesting additional important potential clinical benefit.

Durability of Response: As of the data cutoff date, 55% of patients showed sustained clinical benefit, with notable durations of response of over 16 weeks and with one patient exceeding 80 weeks.

Cross-Cancer Effectiveness: 100% of RCC patients and 60% of NSCLC patients in the study demonstrated positive clinical outcomes, indicating potential efficacy across different cancer types.

With these encouraging early results, it is important to note that the study remains ongoing. Further data will become available and analyzed through the next few months to gain a deeper understanding of the therapeutic potential of BMC128 in combination with nivolumab in cancer treatment.

Prof. Gal Markel, Director of the Davidoff Cancer Center, Rabin Medical Center and Biomica's Scientific Advisory Board member, said: "The positive trends emerging from the ongoing Phase 1 trial of BMC128, particularly in combination with nivolumab, underscore the transformative potential of microbiome-based therapeutics in oncology. These findings bring hope to patients contending with refractory RCC, NSCLC, and melanoma, envisioning a future where innovative treatments like BMC128 could provide meaningful solutions to longstanding challenges in cancer care. Additionally, the observed cross-cancer effectiveness hints at BMC128's broad applicability across different cancer types, further solidifying its significance in the field of oncology. The demonstrated safety profile thus far, alongside the encouraging clinical benefits including response rate and notable durability, accentuates the potential efficacy of BMC128 in addressing the unmet needs of patients grappling with these malignancies. These initial results mark a significant advancement, reflecting our steadfast commitment to pioneering innovative solutions that address critical unmet needs in oncology."

Dr. Elran Haber, Biomica CEO, stated, "The preliminary results from this Phase 1 study show positive evidence of BMC128's superior safety profile and potential efficacy when combined with anti-PD1 checkpoint inhibitor immunotherapy. This suggests potential benefits for patients with refractory NSCLC, melanoma, or RCC who have not responded to, or developed resistance to previous immunotherapy treatments. We believe BMC128 has the promise to be a potential therapy for patients fighting cancer, and we look forward to continuing to evaluate BMC128's beneficial activity in subsequent phases of clinical development. Furthermore, these results underscore the strength of Biomica's computational platform for microbiome drug discovery, developed with Evogene, validating our approach to innovative therapeutic solutions."

Additional information about the trial, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT05354102).

About ASCO:

Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to the principle that knowledge conquers cancer. Together with the Association for Clinical Oncology, ASCO represents nearly 45,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of high quality, equitable patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. The ASCO Annual Meeting is a unique and unparalleled opportunity to connect with one of the largest, most diverse audiences in global cancer care as well as global cancer experts and professionals, to discover the latest innovations in cancer research and education.

About BMC128:

BMC128 is a rationally-designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene's MicroBoost AI platform.

Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbour specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host's microbial community with individually selected, cultured bacteria.

About Biomica Ltd.:

Biomica is a clinical stage biopharmaceutical company developing innovative microbiome-based therapeutics utilizing PRISM system, a proprietary computational platform powered by Evogene's MicroBoost AI tech-engine. licensed from Evogene. Biomica aims to identify and characterize disease-related microbiome entities and to develop novel therapeutics based on these understandings. The company is focused on the development of therapies for antibiotic resistant bacteria, immuno-oncology, and microbiome-related gastrointestinal (GI) disorders. Biomica is a subsidiary of Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN).

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

About Evogene Ltd.:

Evogene (Nasdaq: EVGN, TASE: EVGN) is a computational biology company aiming to revolutionize the development of life-science-based products by utilizing cutting-edge technologies to increase the probability of success while reducing development time and cost. Evogene established three unique tech-engines - MicroBoost AI, ChemPass AI, and GeneRator AI – leveraging Big Data and Artificial Intelligence and incorporating deep multidisciplinary understanding in life sciences. Each tech-engine is focused on the discovery and development of products based on one of the following core components: microbes (MicroBoost AI), small molecules (ChemPass AI), and genetic elements (GeneRator AI).

Evogene uses its tech-engines to develop products through subsidiaries and strategic partnerships. Evogene's subsidiaries currently utilize the tech-engines to develop human microbiome-based therapeutics by Biomica, ag-biologicals by Lavie Bio, ag-chemicals by AgPlenus, medical cannabis products by Canonic and castor varieties, for the biofuel and other industries, by Casterra.

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

Forward-Looking Statements:

This press release contains "forward-looking statements" relating to future events. These statements may be identified by words such as "will", "may", "could", "expects", "intends", "anticipates", "plans", "believes", "scheduled", "estimates", "demonstrates", or words of similar meaning. For example, Evogene and Biomica are using forward-looking statements in this press release when they discuss the safety and potential efficacy of BMC128 and its potential benefits for patients with refractory NSCLC, melanoma, or RCC who have not responded to or developed resistance to previous immunotherapy treatments. Such statements are based on current expectations, estimates, projections and assumptions, describe opinions about future events, and involve certain risks and uncertainties which are difficult to predict and are not guarantees of future performance. Therefore, actual future results, performance or achievements of Evogene and its subsidiaries may differ materially from what is expressed or implied by such forward-looking statements due to a variety of factors, many of which are beyond the control of Evogene and its subsidiaries, including, without limitation, the current war between Israel Hamas and Hezbollah and any worsening of the situation in Israel such as further mobilizations or escalation in the northern border of Israel and those risk factors contained in Evogene's reports filed with applicable securities authorities. Evogene and its subsidiaries disclaim any obligation or commitment to update these forward-looking statements to reflect future events or developments or changes in expectations, estimates, projections, and assumptions.

Logo: https://mma.prnewswire.com/media/1974949/Biomica_Logo.jpg
Logo: https://mma.prnewswire.com/media/1947468/Evogene_Logo.jpg

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Evogene Logo
Evogene Investor Relations Contact:
Rachel Pomerantz Gerber
Head of Investor Relations at Evogene
rachel.pomerantz@evogene.com
Tel: +972-8-9311901

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SOURCE Biomica Ltd.


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Join Can-Fite’s Exclusive Live Investor Webinar and Q&A Session on June 6

https://finance.yahoo.com/news/join-fite-exclusive-live-investor-110000960.html

RAMAT GAN, Israel, May 23, 2024--(BUSINESS WIRE)--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, is pleased to invite investors to a webinar on June 6, 2024, at 4:15 p.m. ET.

The exclusive event, hosted by RedChip Companies, will feature Can-Fite CEO Motti Farbstein and Executive Chairperson and Chief Scientific Officer Pnina Fishman, PhD, who will share insight into the Company’s current development pipeline and upcoming milestones.

To register for the free webinar, please visit: https://redchip.zoom.us/webinar/register/WN_5wAzUm6ESGmdkNGCUkIrOw#/registration

Questions can be pre-submitted to CANF@redchip.com or online during the live event.

Evogene Reports First Quarter 2024 Financial Results

https://finance.yahoo.com/news/evogene-reports-first-quarter-2024-110000510.html

Conference call and webcast: today, May 23, 2024, 9:00 am ET

Financial and Business Highlights:

Q1 2024 revenue: $4.2M vs. $0.6M in Q1 2023; anticipating continued growth in 2024.

Q1 2024 net loss: $3.8M vs. $7.0M in Q1 2023.

Projected 2024 cash usage, excluding Lavie Bio and Biomica: $8.0M, down 36% from $12.5M in 2023.

Ceasing Canonic's operations results in annualized savings of approximately $1.5 million.

Casterra's new agreements with African and Brazilian castor seed growers secure 900 tons of castor seeds, expected to fulfill all standing orders by end of 2024.

Biomica to present preliminary Phase 1 clinical trial results for BMC128 at the 2024 ASCO conference on June 3.

Lavie Bio received $2.5M, the second half of advanced payment from Corteva; announced new collaboration with Syngenta for bio insecticides; extended trials with Bayer for bio fungicides. Marketing and sales for Yalos™ are expanding in the US and Canada, with more crops added.

AgPlenus announced a new collaboration with Bayer, including an upfront payment, research funding, milestone payments, and future royalties; achieved a milestone with Corteva in an existing collaboration agreement.

REHOVOT, Israel, May 23, 2024 /PRNewswire/ -- Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize the development of life-science-based products, today announced its financial results for the first quarter period ended March 31, 2024.

Mr. Ofer Haviv, Evogene's President and CEO, stated: "Evogene's mission is to direct and accelerate the development of life-science based products. During the past years we developed three innovative AI tech-engines addressing the main development challenges of 3 life-science based product categories:

MicroBoost AI – for the development of microbe-based products,

ChemPass AI – for small-molecule-based products, and

GeneRator AI – for products based on genetic elements.

Our AI tech-engines were structured to be compatible with the tremendous potential of various market segments and not limited to only one specific segment.

In order to capture the value of our AI tech-engines, our business strategy is to establish diverse collaborative partnerships through licensing or collaboration, with expert partners in specific fields that complement our technology. Together, we'll develop novel products, aiming for full or partial ownership upon project completion.

This approach maximizes the potential of our AI tech-engines, while reducing financial and development risks. We believe this strategy holds the potential for groundbreaking innovations and significant financial gains for Evogene.

Today, Evogene has 4 subsidiary companies, and diverse engagements with leading companies in additional market segments, not covered by our subsidiaries.

I am very pleased to share with you the main achievements made by Evogene and its subsidiaries from the beginning of the year."

Evogene Updates:

Ceasing Canonic's operation - Evogene has decided to cease its subsidiary Canonic, which specialized in customized medical cannabis products, following challenging market conditions in the medical cannabis sector. This decision results in annualized savings of approximately $1.5 million. Resources will be reallocated to areas with greater growth potential, such as funding Casterra's needs for on-going capital.

Establishment of Finally Foods - In March 2024, Evogene and The Kitchen FoodTech Hub by Strauss Group, established Finally Foods Ltd., an AI-driven company focused on sustainable protein production in plants, for the food sector. Finally Foods will leverage Evogene's AI technology to modify plants for efficient protein production. The company has secured pre-seed funding from TKH and the Israeli Innovation Authority. Evogene holds approximately 40% stake in the company.

Collaboration with Verb Biotics - In February 2024, Evogene and Verb Biotics entered into a collaboration agreement to advance probiotic innovation by developing new strains of probiotic bacteria that produce sustainable quantities of microbial metabolites, which enhance human health and vitality. The partnership will leverage Evogene's MicroBoost AI tech-engine and Verb Biotics' expertise in microbiome health.

Subsidiaries Updates:

Casterra Ag Ltd. – focuses on developing an integrated solution to enable large-scale commercial cultivation of castor to address the global demand for stable castor oil supply, mainly for the biodiesel industry. Casterra is utilizing GeneRator AI tech engine to direct and accelerate the development of its unique elite castor seed varieties.

Under the supervision of Casterra's new CEO, the company has recently engaged with castor seed growers in Africa and Brazil. These engagements are expected to yield approximately 900 tons of castor seeds in 2024, fulfilling all existing purchase orders and providing additional inventory later this year. The balance of the existing purchase orders is anticipated to be delivered in the second half of 2024.

Biomica Ltd. - a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics, utilizing Evogene's MicroBoost AI tech-engine.

In January, 2024, Biomica reached a significant milestone by completing Phase I trial enrollment for its microbiome-based immuno-oncology drug BMC128 - a rationally designed consortia of 4 bacteria. Biomica recently announced that it will be presenting preliminary Phase 1 study data of BMC128 in a poster presentation at the 2024 ASCO Annual Conference, on June 3rd.

Biomica is now preparing for advancing to Phase 2 of BMC128 clinical trial, and already conducted a pre-IND meeting with the FDA, aiming to initiate Phase 2 in 2025.

Results from Biomica's pre-clinical study in the IBS program, conducted in collaboration with NYU's medical school, were presented at the Digestive Disease Week 2024 Annual Conference in May 2024.

Lavie Bio Ltd. - a leading ag-biologicals company that develops microbiome-based, computational-driven novel bio-stimulant and bio-pesticide products, utilizing Evogene's MicroBoost AI tech-engine.

In February, 2024, Lavie Bio announced that it had met the requirements of its licensing agreement for LAV311 & LAV312 with Corteva. This achievement enabled the successful receipt of the second half of an advanced payment, amounting to $2.5 million, bringing the total to $5 million.

In February, 2024, Lavie Bio signed an agreement with Syngenta for the development of new biological insecticidal solutions.

Lavie Bio has extended its joint validation trials with Bayer for its bio-fungicides, following successful laboratory and greenhouse testing. This joint effort, aimed at combating diseases affecting fruits and vegetables globally, has moved to field experiments for further validation.

In March, 2024, Lavie Bio partnered with Ceres Global Ag Corp. to integrate its bio-inoculant, Yalos™, into regenerative agriculture programs across North America. This announcement and other marketing and sales efforts support the penetration of Yalos™ in US and Canada markets with additional crops being added for treatment. Based on initial orders and sales projections, 2024 revenues are anticipated to increase compared to the previous year.

AgPlenus Ltd. - a global leader in computational design and development of novel sustainable crop protection products, utilizing Evogene's ChemPass AI tech-engine.

In February, 2024, AgPlenus announced a licensing and collaboration agreement with Bayer to develop a novel mode of action broad-spectrum herbicide targeting the APTH1 protein. The agreement entitles AgPlenus to an upfront payment, which was received on March 2024, ongoing research funding, milestone payments, and royalties based on future product sales. Bayer will have the exclusive license for developing and commercializing products resulting from this collaboration.

In March, 2024, AgPlenus announced achieving a milestone under its existing collaboration with Corteva to develop new herbicides through a novel mode of action, APCO12, discovered by AgPlenus. The next phase of this collaboration will focus on optimizing the herbicide candidates towards a commercial-level product.

Financial Highlights:

Cash Position: As of March 31, 2024, Evogene held consolidated cash, cash equivalents, and short-term bank deposits of approximately $26.6 million, compared to approximately $31.1 million as of December 31, 2023. The consolidated cash usage during the Q1 2024 was approximately $4.5 million. Excluding Lavie Bio and Biomica, Evogene and its other subsidiaries used approximately $3.4 million in cash. Projected cash usage for 2024, excluding Lavie Bio and Biomica, is expected to be around $8.0 million, marking a notable 36% decrease from approximately $12.5 million in 2023.

Revenue: Revenues for the first quarter of 2024 were approximately $4.2 million, a significant increase from approximately $0.6 million in the same period the previous year. This growth was primarily driven by revenues recognized from Lavie Bio's licensing agreement with Corteva and AgPlenus's new collaboration with Bayer. Evogene anticipates continued revenue growth in 2024 compared to the previous year, mainly in the second half of 2024 based on Casterra's forecast for seed-order supply.

R&D Expenses: Research and development expenses for the first quarter of 2024 were stable at approximately $4.8 million, net of non-refundable grants, consistent with the same period in the previous year.

Sales and Marketing Expenses: These expenses increased to $992 thousand in the first quarter of 2024 compared to $800 thousand in the same period of the previous year. The increase was driven by heightened sales and marketing activities for Casterra's elite seed varieties and Lavie Bio's first commercial product, Yalos™.

General and Administrative Expenses: General and administrative expenses rose to approximately $1.7 million in the first quarter of 2024, compared to approximately $1.5 million in the same period of the previous year, mainly due to non-cash compensation for subsidiary CEOs.

Other Expenses: The decision to cease Canonic's operations resulted in recording other expenses of approximately $0.5 million, mainly due to impairment of fixed assets.

Operating Loss: The operating loss for the first quarter of 2024 was approximately $4.1 million, a decrease from $6.8 million in the same period of the previous year, mainly due to increased revenues.

Financing Income: Financing income net for the first quarter of 2024 was $241 thousand, compared to financing expenses net of $230 thousand in the same period of the previous year. This improvement was primarily due to increased interest income and revaluation of convertible SAFE.

Net Loss: The net loss for the first quarter of 2024 was approximately $3.8 million, compared to approximately $7.0 million in the same period last year. The $3.2 million decrease in net loss was primarily due to increased revenues and financial income, partially offset by the one-time $519 thousand other expenses related to ceasing Canonic's operations.

For the financial tables click here.

Conference Call & Webcast Details: Thursday, May 23, 2024. 9:00 AM EST 4:00 PM IDT
To join the Zoom conference, please register in advance here

Or join via audio
Or, dial: US: +1 253 215 8782 or +1 301 715 8592 or +1 305 224 1968 or +1 309 205 3325 or +1 312 626 6799 or +1 346 248 7799 or +1 360 209 5623 or +1 386 347 5053 or +1 507 473 4847 or +1 564 217 2000 or +1 646 558 8656 or +1 646 931 3860 or +1 669 444 9171 or +1 689 278 1000 or +1 719 359 4580 or +1 720 707 2699 or +1 253 205 0468
More International numbers

Webinar ID: 871 1216 5951

Webcast & Presentation link available at:
https://evogene.com/investor-relations/

BioLineRx to Report First Quarter 2024 Results on May 28, 2024

https://finance.yahoo.com/news/biolinerx-report-first-quarter-2024-110000669.html

Management to Hold Conference Call at 8:30 a.m. EDT

TEL AVIV, Israel, May 22, 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 quarter ended March 31, 2024 on Tuesday, May 28, 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 May 30, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

BioLineRx Announces Receipt of Nasdaq Minimum Bid Price Notification

https://finance.yahoo.com/news/biolinerx-announces-receipt-nasdaq-minimum-210000244.html

TEL AVIV, Israel, May 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) ("BioLineRx" or the "Company"), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it has received a notification letter from the Nasdaq Stock Market LLC ("Nasdaq"). The letter notifies the Company that it is not in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rules for continued listing on the Nasdaq Capital Market, since the closing bid price for the Company's American Depositary Shares ("ADSs") listed on the Nasdaq was below USD $1.00 for 30 consecutive trading days. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of USD $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.

The Notice has no immediate effect on the Company's Nasdaq listing or the trading of its ADSs, and during the grace period, as may be extended, the Company's ADSs will continue to trade on the Nasdaq under the symbol "BLRX".

In accordance with Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or until November 11, 2024, to regain compliance with the minimum bid price. If at any time before November 11, 2024 the bid price of the Company's ADSs closes at or above USD $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the minimum bid price requirement.

In the event the Company does not regain compliance by November 11, 2024, the Company may be eligible for an additional 180 days to regain compliance if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price requirement. In this case, the Company will need to provide written notice of its intention to cure the deficiency during the second compliance period.

The Company will continue to monitor the closing bid price of its ADSs on the Nasdaq between now and November 11, 2024 and seek to cure the deficiency within the prescribed compliance period. The Company's business operations are not affected by the notification letter.

If the Company cannot demonstrate compliance by the allotted compliance period(s), Nasdaq's staff will notify the Company that its ADSs are subject to delisting.

The Company's ordinary shares are also listed on the Tel Aviv Stock Exchange and the notification letter does not affect the Company's compliance status with such listing.