On April 1, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported positive preliminary data from the ongoing, signal seeking Phase 2 portion of the Phase 2/3 study evaluating GRANITE, its personalized neoantigen cancer vaccine, in front-line metastatic microsatellite stable colorectal cancer (MSS-CRC) (Press release, Gritstone Bio, APR 1, 2024, View Source [SID1234641656]). The randomized, controlled, open-label study is designed to quantify the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902) in combination with immune checkpoint blockade in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression free survival (PFS) data show an early trend in benefit for GRANITE patients (HR=0.82, [95% CI, 0.34-1.67]; 62% censored) and extended PFS benefit in high-risk patients (HR=0.52 [95% CI, 0.15-1.38]; 44% censored), in whom progression occurs faster. Circulating tumor DNA (ctDNA) analysis over several months of treatment shows the expected relationship with disease progression and favors GRANITE, while short-term ctDNA response analysis (molecular response as defined per protocol) did not demonstrate a difference between study arms. Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).

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"Today’s preliminary Phase 2 results are highly encouraging and represent the first randomized trial evidence, albeit early, that a personalized neoantigen-directed vaccine can potentially drive efficacy in a metastatic ‘cold’ tumor. The overall trend of PFS improvement in GRANITE recipients is great to see, and the exploratory PFS hazard ratio of 0.52 in the high-risk group, a more mature dataset, is a striking signal," said Andrew Allen, MD, PhD, Co-founder, President & CEO of Gritstone bio. "Pioneering new spaces carries inherent risks, and with regard to defining molecular response, we simply got it wrong. ctDNA levels in both arms decreased on chemotherapy for longer than we anticipated, generating similar short-term molecular response rates across arms and rendering our protocol measure of ctDNA change uninformative. Fortunately, long-term analysis demonstrates the expected correlation of ctDNA with clinical benefit and favors GRANITE patients. We believe these preliminary findings put us in a strong position to share mature PFS data in the third quarter and then enter regulatory discussions regarding Phase 3. The growing body of evidence favoring GRANITE in this trial, including positive PFS and long-term ctDNA trends in both high and low-risk populations, is exciting and suggests GRANITE is working in this notoriously underserved patient population."

"Up to 97% of patients with metastatic colorectal cancer, the second most common cause of cancer death, are MSS. Unlike patients with melanoma and lung cancer, they have not benefited from standard immunotherapies such as checkpoint inhibitors. These preliminary results indicate that GRANITE is inducing a potentially significant immune response in a disease that has been felt to be immunologically cold," said J. Randolph Hecht, MD, Professor of Clinical Medicine and Director of the UCLA GI Oncology Program and an investigator in the GRANITE Phase 2/3 study. "The PFS difference, particularly in a poor prognosis group of patients, indicates the potential for clinical benefit and provides the rationale for a confirmatory Phase 3 trial, about which I am very excited. Furthermore, we are learning how to better analyze ctDNA continuously to study the efficacy of this novel immunotherapy. Expanding the scope of immunotherapy to a broader spectrum of cancer patients is the ‘holy grail’ of oncology, especially for MSS colorectal cancer. While early, these promising results suggest GRANITE has potential to deliver clinically meaningful benefit in MSS-CRC and other cold tumors."

Key Findings from Preliminary Phase 2 Data in Front-Line Metastatic MSS-CRC
Clinical data cut as of March 8, 2024; ctDNA data cut as of March 12, 2024

One hundred and four (104) patients were randomized (1:1) in the study: Sixty-seven (67) patients (39 GRANITE arm, 28 control arm) are included in the treated analysis below. Thirty-six patients have left the study prior to randomized treatment primarily due to early progressive disease or withdrawal of consent, and one patient has yet to begin study treatment start. Demographics and clinical characteristics were balanced between arms (stage, sidedness, presence of liver metastases), with approximately 75% of patients having liver metastases.

Progression Free Survival (PFS)

Early trend in PFS benefit was observed for GRANITE recipients
Hazard ratio of 0.82 ([95% CI, 0.34-1.67]; 62% censored) in all patients
Hazard ratio of 0.52 ([95% CI, 0.15-1.38]; 44% censored) in high-risk patients1 (>90% have liver metastases). Median PFS of 12 months (GRANITE) vs. 7 months (control).
1High-risk subgroup defined as baseline ctDNA above the median value (2%) for the control group (ctDNA quantified as mean variant allele frequency [VAF] at time of study randomization). This analysis was performed on 44 patients who received study treatment (control and GRANITE arms) and have available baseline ctDNA data.
GRANITE and control arms begin separating 1-2 months after initiation of GRANITE treatment, consistent with expected kinetics of GRANITE-induced immune response
Biomarker Results – Circulating Tumor DNA (ctDNA)

Short-term molecular response (>30% reduction in ctDNA using single time-point analysis, defined per protocol) is uninformative due to unanticipated continuation of ctDNA drop beyond induction chemotherapy.
Molecular response, similar in both arms (30% [6/20] in vaccine arm; 42% [5/12] in control arm)
Long-term ctDNA responses align with PFS trends and favor GRANITE vs. control patients
Analysis in the high-risk group1 shows that between first blood draw (time of randomization) and last blood draw (most recent study visit), ctDNA shifted from high (>2% VAF) to low (≤2% VAF) in 56% (9/16) of GRANITE patients vs 22% (2/9) of control patients. Progressive disease was observed in 44% (7/16) vs 78% (7/9), respectively, within this group.
Analysis in patients whose ctDNA was negative after induction chemotherapy, a low-risk group, favors GRANITE. Sustained ctDNA negativity was observed in 67% (6/9) of GRANITE recipients vs 38% (3/8) control patients. Progressive disease was observed in 11% (1/9) and 38% (3/8) of these patients, respectively.
Safety and Tolerability

GRANITE demonstrated a favorable safety and tolerability profile
Vast majority of adverse events (AEs) were Grade 1/2
Common AEs were mild systemic and local effects typically associated with any potent vaccine (i.e., transient flu-like illness)
No patients discontinued study treatment due to an AE
A presentation reviewing these results has been added to the Presentations page of Gritstone’s website, View Source

On April 1, 2024 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2024 Annual Meeting, taking place May 7 – 11, 2024, in Baltimore, MD and virtually (Press release, CRISPR Therapeutics, APR 1, 2024, View Source [SID1234641655]).

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Title: Development of an In Vivo Non-Viral Ocular Editing Platform and Application to Potential Treatments for Glaucoma
Session Type: In-Person Oral Presentation
Session Title: Ophthalmic and Auditory: Delivery Innovations
Abstract Number: 87
Location: Room 318 – 323
Session Date and Time: Wednesday, May 8, 2024, 1:30 p.m. – 3:15 p.m. ET

Abstracts will be released to the public on April 22, 2024, at 4:30 p.m. ET at View Source The data are embargoed until 6:00 a.m. ET on the presentation day, Wednesday May 8, 2024. A copy of the presentation will be available at www.crisprtx.com once the presentation concludes.

On April 1, 2024 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the full year ended December 31, 2023 and outlined recent corporate and clinical development highlights (Press release, CNS Pharmaceuticals, APR 1, 2024, View Source [SID1234641654]).

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John Climaco, CEO of CNS Pharmaceuticals, stated, "There remains a tremendous unmet medical need for an effective treatment for GBM, and we are dedicated to advancing this important program forward to bring much needed hope for patients. Over the course of 2023 we made significant progress with our lead development program, Berubicin, having recently achieved four primary objectives toward which we were actively working: maintain a rapid pace of enrollment to reach our pre-planned interim analysis; complete planned enrollment; bolster buy-in from investigators; and expand our board indicating a strong support system from industry leaders."

"In addition to reaching complete enrollment we have also successfully completed the interim futility analysis and received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the study without modification, which we believe is a monumental step towards our objective of seeing Berubicin approved. Additionally, we have added noteworthy members to our Board who have the knowledge and expertise to help drive our efforts forward. With these achievements behind us, we are closer to fulfilling our mission and promise to patients and shareholders to bring Berubicin across the finish line towards approval," concluded Mr. Climaco.

Recent Achievements

· Closed a public offering for gross proceeds of $4.0 million;
· Appointed biotech commercialization leader Amy Mahery to the Company’s Board of Directors;
· Announced successful outcome to the pre-planned interim futility analysis of efficacy and safety in the Company’s ongoing global, potentially pivotal trial of Berubicin for the treatment of GBM; and
· Reached full enrollment in study of Berubicin for the treatment of GBM.

Berubicin Clinical Development Progress

The trial design of our potentially pivotal trial of Berubicin included a pre-planned, non-binding interim futility analysis. The Company reached the criteria required by the study protocol to conduct this interim futility analysis, which an independent DSMB is responsible for conducting. The DSMB’s charter mandated that they review the primary endpoint, Overall Survival, as well as secondary endpoints and safety data to determine whether the efficacy data for the risk-benefit profile warrants modification or discontinuation of the study. On December 18, 2023, the Company released the DSMB’s recommendation which was to continue the study without modification. Management remains blinded to the data underlying the recommendation of the DSMB.

The Company expects to report topline data from its study of Berubicin in the first half of 2025, although it is impossible to accurately predict how long patients on the study may survive, which could impact the timing of the release of topline data.

For more information about Berubicin clinical trial, visit clinicaltrials.gov and reference identifier NCT04762069.

Summary of Financial Results for the Full Year 2023

The net loss for the year ended December 31, 2023 was approximately $18.9 million compared to approximately $15.3 million for the comparable period in 2022. The change in net loss is primarily attributable to increased research and development costs.

The Company reported research and development expenses of $14.1 million for the year ended December 31, 2023 compared to approximately $9.3 million for the comparable period in 2022. The increase in research and development expenses during the period were mainly attributed to the timing of research organization (CRO) expenses and patient treatment costs related to continued progress with our clinical trial for Berubicin.

General and administrative expenses were approximately $4.8 million for the year ended December 31, 2023 compared to approximately $6.0 million for the comparable period in 2022. This change is primarily attributable to a decrease of approximately $792,000 in professional expenses, $488,000 in employee compensation, $141,000 in stock-based compensation and $92,000 in insurance expenses. These changes were offset by increases of approximately $145,000 in travel expenses, board of director compensation of $96,000, advertising and marketing of $68,000 and other general and administrative expenses of $7,000.

As of December 31, 2023, the Company had cash of approximately $0.5 million. Subsequent to the end of 2023, the Company closed a $4.0 million public offering with participation from healthcare-focused institutional investors, retail investors, and certain officers and directors of the Company. Management anticipates that its cash on hand as of December 31, 2023, combined with capital raised subsequent to December 31, 2023, is sufficient to fund its planned operations into but not beyond the latter half of the second quarter of 2024.

About Berubicin

Berubicin is the Company’s novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, for the treatment of GBM, an aggressive and incurable form of brain cancer.

Berubicin is currently being evaluated in a potentially pivotal, multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line therapy and compared to Lomustine. The study has enrolled 252 patients across 46 clinical trial sites in the U.S., Italy, France, Spain, and Switzerland. The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint the FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the agency for guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA, which may provide seven years of marketing exclusivity upon approval of an NDA.

On April 1, 2024 Biomea Fusion, Inc. ("Biomea" or "the Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported fourth quarter and full year 2023 financial results and corporate highlights (Press release, Biomea Fusion, APR 1, 2024, View Source [SID1234641653]).

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"2023 was a pivotal year for Biomea as we reported first positive data in type 2 diabetes and initiated our first clinical study in type 1 diabetes. We also announced initial positive data in AML in 2023. It has been gratifying to see the ongoing and continued improvement in HbA1c after only a 4-week dosing period with BMF-219 in type 2 diabetes patients with poorly controlled diabetes. Critically, we have now evaluated BMF-219 out to 26 weeks, or 5 months, after the last dose of BMF-219, and reported promising longer-term data. Based on these clinical and our preclinical findings we have observed with confidence, that the inhibition of menin is correlated with beta cell proliferation and function, and is providing durable effects for patients," stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. "Our preclinical data showed also that longer inhibition of menin at higher doses increased beta cell mass and function, as well as promoted controlled proliferation and enhanced insulin content in beta cells. We have now initiated expansion cohorts to evaluate the translation of these preclinical findings in the clinical setting. We believe BMF-219 has the potential to address the root cause of diabetes and modify disease progression in patients across a broad spectrum of clinical profiles, from early to later stage treatment. Our goal is to deliver a short-term, non-chronic treatment that will reconstitute insulin-producing beta cells, allowing the patients’ own bodies to normalize blood sugar levels. Importantly, we continued to build a first-class pipeline of covalent inhibitors. In 2023 BMF-500 entered the clinic as the only covalent FLT3 inhibitor in clinical development."

Mr. Butler continued, "We anticipate 2024 will be an even more momentous year for Biomea, as we steadily march toward late-stage clinical development in both type 2 and type 1 diabetes. This year, we plan to complete and report the results of dosing and follow-up of over 200 type 2 diabetes patients enrolled in our Phase 2 expansion cohorts. We expect these data will inform potentially registrational studies, which we plan to start in 2025, pending discussions with regulatory authorities. In 2024, we also expect to report data from 40 patients enrolled in the open label portion of our Phase 2 study in type 1 diabetes patients. On the oncology front, we will continue patient enrollment in our liquid and solid tumor studies of BMF-219 and BMF-500 and anticipate completing the dose escalation steps in each of the cohorts as well this year. Since our launch as a public company just over three years ago, we have consistently demonstrated the ability to accelerate innovative science and execute against aggressive development timelines. In 2024, we’ll continue to work methodically yet quickly to deliver the patient data required for potentially registrational studies we are planning to begin in the following year."

RECENT UPDATES & ANTICIPATED 2024 MILESTONES

DIABETES

COVALENT-111 (BMF-219 for Type 2 Diabetes)

Presented proof-of-concept data supporting the proposed mechanism of action of BMF-219 with clinical data in a Phase 2 study after 4 weeks of dosing:
Compared to baseline, 84% of all type 2 diabetes patients failing standard of care with poorly controlled diabetes (HbA1c > 7.0% and < 10%) dosed for only four weeks with BMF-219 showed a reduction in HbA1c at week 4 and 74% at week 12 (n=32), two months after the final dose of BMF-219. 60% of type 2 diabetes patients dosed with 100 mg without food achieved a controlled HbA1c of 7% or below at the end of week 12, two months after the last dose of BMF-219. Across 100 mg QD, 200 mg QD, and 100 mg BID cohorts (N=40), 38% of patients had ≥0.5% HbA1c reduction (with a mean HbA1c reduction of 1.2%), and 23% of patients had ≥1.0% HbA1c reduction (with a mean HbA1c reduction of 1.5%) at Week 26, 5 months after the last dose of BMF-219.
Patients in COVALENT-111 are displaying improved glycemic control while off therapy, supporting improved pancreatic function following BMF-219 treatment. Patients who demonstrated the greatest HbA1c reduction at Week 26 (22 weeks off treatment), had the greatest improvement in beta cell function as measured by HOMA-B and C-peptide.
BMF-219 was generally well tolerated with no serious adverse events and no adverse event-related study discontinuations, and no symptomatic or clinically significant hypoglycemia.
FDA and Health Canada cleared the initiation of the expansion portion of this Phase 2 study, which will evaluate BMF-219 administered at 100 mg and 200 mg, with dosing durations up to 12 weeks in a minimum of 216 type 2 diabetes patients.

Anticipated 2024 Milestones:
On track to complete 400 mg cohort to inform the Escalation Phase Arm D design.
On track to complete enrollment of the three expansion cohorts of COVALENT-111 (n=216) in type 2 diabetes patients with poorly controlled diabetes and provide 26 week follow up data.
COVALENT-112 (BMF-219 for Type 1 Diabetes)

FDA and Health Canada cleared the IND / CTA for Phase 2 study COVALENT-112 of BMF-219 in type 1 diabetes patients. The study is designed to enroll 150 adults with type 1 diabetes and examine the safety and efficacy of BMF-219 at two oral dose levels, 100 mg and 200 mg, for 12 weeks of treatment followed by a 40 week off-treatment period. The trial will also include an open label portion (n=40), enrolling participants with type 1 diabetes up to 15 years since diagnosis.
Dosed the first 2 type 1 diabetes patients in COVALENT-112.

Anticipated 2024 Milestones:
On track to complete enrollment of the open label portion (n=40) and establish the initial proof of concept based on clinical data in type 1 diabetes patients treated in COVALENT-112 with BMF-219.
ONCOLOGY

COVALENT-101 (BMF-219 for Liquid Tumors)

Presented initial Phase 1 topline data in AML with first complete responder achieving minimal residual disease negativity, with no dose-limiting toxicities observed and no adverse event related treatment discontinuations.
Continued patient enrollment exploring BMF-219’s utility in liquid tumors (AML/ALL, MM, CLL, DLBCL).

Anticipated 2024 Milestones:
On track to complete dose escalation portion of COVALENT-101 in liquid tumors and establish recommended Phase 2 dose (RP2D).
COVALENT-102 (BMF-219 for KRAS-Mutant Solid Tumors)

Continued patient enrollment exploring BMF-219’s utility in KRAS-driven solid tumors (PDAC, NSCLC, CRC).

Anticipated 2024 Milestones:
On track to complete dose escalation portion of COVALENT-102 in solid tumors and establish RP2D.
COVALENT-103 (BMF-500 for Acute Leukemias)

Announced FDA clearance of IND for BMF-500 in COVALENT-103, a Phase 1 study, and started enrollment of Biomea’s novel third generation investigational oral covalent inhibitor of FMS-like tyrosine kinase 3 (FLT3).

Anticipated 2024 Milestones:
On track to complete dose escalation portion of COVALENT-103 and establish RP2D.
FUSIONTMSYSTEM DISCOVERY PLATFORM

Built out and opened new lab facilities to validate and progress in-house research efforts.
Continued the development of the Biomea FUSION Platform technology.

Anticipated 2024 Milestones:
On track to announce a third development candidate from the Biomea FUSION Platform technology.

FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS

Cash, Cash Equivalents, Restricted Cash, and Investments: As of December 31, 2023, the Company had cash, cash equivalents and restricted cash of $177.2 million, compared to $113.4 million as of December 31, 2022.
Net Income/Loss: The Company reported a net loss attributable to common stockholders of $34.9 million for the three months ended December 31, 2023, compared to a net loss of $25.3 million for the same period in 2022. Net loss attributable to common stockholders was $117.3 million for the year ended December 31, 2023, compared to a net loss of $81.8 million for the same period in 2022.

Research and Development (R&D) Expenses: R&D expenses were $30.9 million for the three months ended December 31, 2023, compared to $20.5 million for the same period in 2022. The increase of $10.3 million was primarily due to an increase in clinical development cost and external consulting related to the Company’s product candidates, BMF-219 and BMF-500, as well as an increase in personnel-related costs and facilities cost due to new lease agreements for additional office and laboratory space. R&D expenses were $102.5 million for the year ended December 31, 2023 compared to $62.7 million for the same period in 2022. The increase of $39.8 million was primarily due to an increase in clinical development and manufacturing costs related to the Company’s product candidates, BMF-219 and BMF-500, an increase in personnel-related costs as well as an increase in facilities cost due to new lease agreements for additional office and laboratory space.

General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the three months ended December 31, 2023, compared to $5.7 million for the same period in 2022. The increase of $0.7 million in was primarily due to increased personnel-related expenses, including stock-based compensation. G&A expenses were $23.6 million for the year ended December 31, 2023 compared to $20.9 million for the same period in 2022. The increase of $2.7 million was primarily due to increased personnel-related expenses, including stock-based compensation, due to an increase in headcount, as well as an increase in professional and consulting services to support the growth of the Company.

On April 1, 2024 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) ("BioLineRx" or the "Company"), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that it has entered into definitive agreements with several institutional investors for the issuance and sale in a registered direct offering of 7,500,000 of the Company’s American Depositary Shares (ADSs) and warrants to purchase up to an aggregate of 7,500,000 ADSs, at a combined purchase price of $0.80 per ADS and accompanying warrant (Press release, BioLineRx, APR 1, 2024, View Source [SID1234641652]). Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The warrants will have an exercise price of $0.80 per ADS, will be exercisable at any time upon issuance and will expire five years from the date of issuance. The offering is expected to close on or about April 1, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering (without taking into account any proceeds from any future exercises of warrants), before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be $6.0 million. BioLineRx intends to use the net proceeds from the offering to support the commercialization of APHEXDA (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in patients with multiple myeloma, advance its pancreatic cancer clinical development program and other pipeline programs, and for general corporate purposes.

"We believe that today’s equity transaction, when combined with the potential drawdown of an additional $20 million tranche from our existing debt facility at favorable interest rates, together with our existing cash, provides the Company with the financial resources to continue building our momentum with the APHEXDA launch and advancing key life cycle programs for long-term growth opportunities", said Philip Serlin, Chief Executive Officer of BioLineRx.

JonesTrading Institutional Services LLC is acting as the exclusive placement agent for the offering.

The offering is being made by the Company pursuant to its shelf registration statement on Form F-3 (File No. 333-276323) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on January 5, 2024, and only by means of a prospectus and prospectus supplement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Alternatively, copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, by sending a request to: JonesTrading Institutional Services LLC, Attention: Equity Capital Markets, 325 Hudson Street New York, New York 10013; email: [email protected].

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