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.

On April 1, 2024 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on commercializing noninvasive tests for the detection of early-stage cancer and lung disease, reported financial results for the three and 12 months ended December 31, 2023 (Press release, BioAffinity Technologies, APR 1, 2024, View Source [SID1234641651]).

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Fiscal Year 2023 and Recent Highlights

● Reported fiscal year 2023 revenue of $2.5 million, a significant increase from $5,000 in 2022, driven by the September 2023 acquisition of Precision Pathology Laboratory Services (PPLS) and increasing sales of CyPath Lung, the Company’s noninvasive test to detect early-stage lung cancer.

● Reported accelerating growth of 350% in CyPath Lung tests ordered and processed in Q1 2024 as compared to Q4 2023, exceeding the Company’s targeted sales forecast for the quarter. The Company continues with its limited market launch in Texas to refine future positioning and strategic insight for CyPath Lung in preparation for expanding to the national market.

● Achieved a milestone with the Centers for Medicare and Medicaid Services (CMS) final determination for payment for CyPath Lung for the 2024 calendar year, a significant step in the Company’s strategic plan to accelerate the commercialization of CyPath Lung.

● Initiated the sale of CyPath Lung tests to the Department of Defense for observational studies and research. This research expands the test’s use and includes the development of a companion test for bronchoalveolar lavage (BAL) samples to be used in conjunction with bronchoscopy.

● Announced the appointment of Michael Dougherty, CPA, MBA, as Chief Financial Officer, bringing extensive experience from his previous role as CFO of Amazon’s Alexa Commercial Domains.

● Developed marketing materials for CyPath Lung in collaboration with leading marketing and advertising firms and began utilizing them with physicians and patients in January 2024, focusing on the test’s value as a tool to assist physicians with patient care decisions.

● Announced the appointment of Dallas Coleman as National Director of Sales and the ongoing expansion of the sales team. Mr. Coleman has more than 15 years of experience in medical sales and marketing, most recently as Executive Account Manager for the respiratory portfolio of Olympus America’s therapeutic solutions division.

● Successfully passed the bi-annual College of American Pathologists (CAP) inspection in January 2024, affirming the high standards of quality and patient care attained by the Company’s commercial laboratory, Precision Pathology Laboratory Services.

● Expanded the Company’s Medical and Scientific Advisory Board with the appointment of Sandeep Bansal, M.D., Medical Director of Pennsylvania’s Lung Innovations Network, a patient-centered practice that offers comprehensive lung care to more than 10,000 patients in central and western Pennsylvania.

● Strengthened the Company’s Board of Directors with the appointment of Jamie Platt, Ph.D., Managing Director and Chief Executive Officer of Pictor Limited, where she is leading a turnaround by restructuring and accelerating product development. Dr. Platt was instrumental in merger and acquisition exits for two diagnostic companies with a combined value of approximately $1 billion.

Management Commentary

"As we reflect on the monumental achievements of bioAffinity Technologies over the past year, I am filled with immense pride and optimism for the future," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. "Our fiscal year 2023 revenue of $2.5 million, up from less than $5,000 in 2022, is not just a number – it’s a testament to the dedication of our team, the quality of Precision Pathology’s operations, the trust of our healthcare partners, and what we believe is the growing recognition of CyPath Lung’s critical role in the early detection of lung cancer."

Ms. Zannes continued, "The CMS’s final payment determination for CyPath Lung for the 2024 calendar year was a major accomplishment that supports our strategic plan to accelerate commercialization. This milestone, coupled with our successful acquisition of Precision Pathology Services and expanding the reach of CyPath Lung through partnerships such as with the Department of Defense, positions us at the forefront of noninvasive lung cancer detection. Our revenue growth is a beacon of our potential and the impact we aim to have on millions of lives by providing accessible, accurate, and noninvasive diagnostic solutions. As we look ahead, we are more committed than ever to building on this momentum and expanding our market to fulfill the promise of early cancer detection and treatment."

Fourth Quarter Financial Results

Revenue for the fourth quarter of 2023 was approximately $2.2 million, up from no revenue for the prior-year period. Revenue was derived from sales and services of the Company’s commercial laboratory, Precision Pathology Laboratory Services, including its sale of CyPath Lung as a Laboratory Developed Test (LDT).

Research and development expenses were $432,000 for the fourth quarter of 2023, compared with $429,000 for the comparable period in 2022. Selling, general and administrative expenses were $2.2 million for the fourth quarter of 2023, compared with $1.2 million for the comparable period in 2022.

Net loss for the fourth quarter of 2023 was $2.4 million, compared with a net loss of $1.7 million for the comparable period in 2022.

Full Year Financial Results

Revenue for 2023 was $2.5 million, up from approximately $5,000 for 2022.

Research and development expenses were $1.5 million in 2023, compared with $1.4 million in 2022. The increase was primarily attributable to an increase in compensation costs and benefits as we added research personnel.

Selling, general and administrative expenses were $6.8 million in 2023, compared with $2.5 million in 2022. The increase was primarily attributable to general and administration costs acquired from PPLS, accounting, legal, and professional fee costs associated with the acquisition of PPLS, the accounting, legal, and professional fee costs associated with the SEC filing of a registration statement on Form S-1, increase in stock-based compensation, increase in employee compensation as we added sales and administrative personnel, increase in branding and marketing collateral, increase in directors and officers insurance, increase in public company-related expenses as well as an increase related to board compensation, and other operational expenses. Additionally, compensation increased due to additional personnel and support services to support the launch of sales of our diagnostic test, CyPath Lung.

Net loss for 2023 was $7.9 million, or $0.91 per share, down from a net loss for 2022 of $8.1 million, or $1.81 per share.

Cash and cash equivalents as of December 31, 2023, were $2.8 million.

About CyPath Lung

CyPath Lung uses advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin, meso-tetra (4-carboxyphenyl) porphyrin (TCPP), that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage cancer can improve outcomes and increase patient survival.

On April 1, 2024 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, reported that preclinical data for ADRX-0706 will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, taking place April 5-10, 2024, in San Diego, CA (Press release, Adcentrx Therapeutics, APR 1, 2024, View Source [SID1234641650]).

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The three presentations will include preclinical data for Adcentrx’s lead ADC program, ADRX-0706. The ADC is comprised of a novel fully human IgG1 antibody targeting human Nectin-4 linked to a novel tubulin inhibitor payload, AP052, through Adcentrx’s proprietary i-Conjugation technology using a cleavable linker and stable conjugation chemistry. This novel platform technology generates highly stable ADCs with a drug-antibody ratio of eight (DAR 8), substantially expanding the therapeutic window of auristatin-based ADCs beyond existing vedotin technology. The preclinical data presentations show improved therapeutic window of ADRX-0706, enhanced bystander effect and improved payload delivery to Nectin-4 expressing tumors while minimizing exposure to normal tissues.

Details of the three AACR (Free AACR Whitepaper) poster presentations are below:

Presentation Title: Preclinical characterization of ADRX-0706: A next-generation anti-Nectin-4 antibody-drug conjugate with improved therapeutic window
Abstract Number: 1891
Session Date & Time: Monday, April 8, 9:00 a.m. – 12:30 p.m. PT
Session Title: Antibody-Drug Conjugates and Bispecific Antibodies

Presentation Title: ADRX-0706 Nectin-4 antibody-drug conjugate PK/PD characterization elucidates its widened therapeutic window
Abstract Number: 1902
Session Date & Time: Monday, April 8, 9:00 a.m. – 12:30 p.m. PT
Session Title: Antibody-Drug Conjugates and Bispecific Antibodies

Presentation Title: Advancing a novel tubulin-inhibitor ADC technology: The Adcentrx auristatin platform offers enhanced efficacy and safety profiles compared to vedotin technology
Abstract Number: 1909
Session Date & Time: Monday, April 8, 9:00 a.m. – 12:30 p.m. PT
Session Title: Antibody-Drug Conjugates and Bispecific Antibodies

About ADRX-0706

ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component targets Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis. ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models, and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.

On April 1, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported that results from the Phase 3 SIERRA trial of Iomab-B in patients with a TP53 mutation have been accepted for oral presentation at the 50th Annual meeting of the European Bone Marrow Transplant Society (EBMT) being held April 14 – 17, 2024, in Glasgow, Scotland. Iomab-B is a targeted radiotherapy conditioning agent comprised of an anti-CD45 monoclonal antibody and Iodine-131 radioisotope payload. The Phase 3 SIERRA trial enrolled 153 patients with active relapsed or refractory acute myeloid leukemia (r/r AML) and compared outcomes of patients receiving Iomab-B and a bone marrow transplant (BMT) to those of patients receiving physician’s choice of care in the control arm. In total, 24% of patients (37/153) in the SIERRA trial had a TP53 mutation, which is associated with poor outcomes, and 27 of the TP53 positive patients received Iomab-B. Iomab-B met the primary endpoint of durable Complete Remission (dCR) in the SIERRA trial with high-statistical significance (p<0.0001) and 100% of patients receiving a therapeutic dose of Iomab-B achieved BMT access and engagement.

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Dr. Hannah Choe, Assistant Professor of Medicine at Ohio State University and SIERRA trial investigator will present the SIERRA results. Details of the oral presentation are as follows:

Title: I-131-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Demonstrates Survival Benefit and Overcomes High-Risk TP53 Mutations in Patients with R/R AML

Date and Time: Wednesday, April 17, 2024, 12:39 PM GMT

Session: OS17-02

Location: Scottish Event Campus (SEC Centre)

Dr. Avinash Desai, Actinium’s Chief Medical Officer, said, "In addition to demonstrating unprecedented 100% access to BMT in Iomab-B treated patients with active r/r AML and achieving the primary endpoint of dCR with high statistical significance, we are excited by the compelling outcomes in patients with a TP53 mutation in the SIERRA trial. We look forward to returning to EBMT and once again highlighting the positive results from the Phase 3 SIERRA trial to the European bone marrow transplant community. We are particularly focused on Europe as it represents the largest bone marrow transplant market performing 40% of the BMT transplants globally. We also look forward to continuing to work with our European, Middle East and North African commercial partner, Immedica Pharma Ab, to bring Iomab-B to patients globally."

About the EBMT Annual Meeting

The Annual Meeting of the EBMT is attended by more than 5,500 participants, including physicians, nurses, data managers, statisticians, quality managers, cell therapists, paediatricians, pharmacists, psychologists, psychiatrists and psychoanalysts, transplant coordinators, lab scientists, trainees, patients. This important congress ensures and encourages dialogues and information exchange, education and scientific productivity.

The full annual meeting program is available online at:
View Source