On May 28, 2024 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported that the Company will present at the following upcoming investor conferences during the month of June (Press release, Dynavax Technologies, MAY 28, 2024, View Source [SID1234643730]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

William Blair 44th Annual Growth Stock Conference on Tuesday, June 4 at 1:20 p.m. CT
Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10 at 4:00 p.m. ET
The presentations will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source

On May 28, 2024 Cartography Biosciences, Inc., reported that it has entered into a strategic collaboration agreement with Gilead Sciences, Inc., to discover and develop therapies for patients with triple-negative breast cancer (TNBC) and the most common form of non-small cell lung cancer (NSCLC), adenocarcinoma (Press release, Cartography Biosciences, MAY 28, 2024, View Source [SID1234643729]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the multi-year collaboration, Cartography’s proprietary computational and genomics platform will be utilized to discover and validate novel tumor-selective target antigens and pairs of antigens. Cartography’s ATLAS and SUMMIT platforms integrate single-cell data from a comprehensive healthy reference and tumor atlas – applying target identification algorithms to identify single or pairs of targets that are most specific to the intended target cells and optimized for therapeutic programs. Gilead can opt in on multiple targets identified through this collaboration and will undertake all further research, development, and commercialization of programs against those targets.

"We are excited to partner with Gilead to identify novel and compelling antigen targets using our ATLAS and SUMMIT platforms," said Kevin Parker, Ph.D., CEO of Cartography Biosciences. "The current target landscape in oncology is growing increasingly crowded and there is an urgent need to provide patients with innovative, targeted medicines. Cartography looks forward to working with Gilead and leveraging the team’s expertise in oncology and drug development to identify tumor-specific targets and target pairs that can lead to transformative therapies for patients."

Under the terms of the agreement, Cartography will receive an upfront payment of $20 million, with additional near-term preclinical milestones. Cartography is also eligible to receive development, regulatory and commercial milestones, and tiered royalties on net sales for Gilead programs against each optioned target.

On May 28, 2024 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the first quarter ended March 31, 2024, and provided recent corporate and portfolio updates (Press release, BioLineRx, MAY 28, 2024, View Source [SID1234643728]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 (Free ASCO Whitepaper) 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) (Free ASCO Whitepaper) 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.

On May 28, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that the Safety Review Committee (SRC) overseeing the ongoing ABOYA-119 clinical trial has determined that dosing of patients with ATRN-119 at 800 mg once daily (Cohort 6) can commence and that Cohort 6 is open for enrollment (Press release, Aprea, MAY 28, 2024, View Source [SID1234643727]). This decision follows review of the safety and pharmacokinetic data from patients treated at 550 mg once daily (Cohort 5).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very pleased with the progress in the ABOYA-119 clinical trial and with the SRC’s recent endorsement to commence dosing of patients with ATRN-119 at 800 mg once daily representing progress in ATRN-119 development," said Nadeem Q. Mirza, M.D., M.P.H., Chief Medical Officer of Aprea. "Pharmacokinetic data show that the duration of systemic exposure substantially increases with each dose level of ATRN-119. New data reported at the recent AACR (Free AACR Whitepaper) annual meeting show that plasma concentrations of the drug are entering the expected therapeutic range at dose levels of 550 mg and above1. We anticipate to announce additional safety and initial efficacy data from this study in the second half of 2024 and to complete dose escalation by the fourth quarter. Overall, we are very excited by ATRN-119, which we believe is differentiated from other ATR inhibitors in selectivity and toxicity profile."

ABOYA-119 is a Phase 1/2a multi-center, open-label, dose-escalation and expansion clinical trial designed to test ATRN-119 monotherapy in patients with advanced solid tumors harboring defined mutations in DDR pathways. Part 1 (Phase 1) of the study is assessing tolerability, pharmacokinetics, recommended Phase 2 dose (RP2D) and analysis of patient biomarkers. At completion of Part 1, the company anticipates identification of a recommended Phase 2 dose that will be used in a Phase 2a cohort expansion (Part 2) to test the tolerability and potential efficacy of ATRN-119 monotherapy For more information, refer to please refer to clinicaltrials.gov NCT04905914.

A total of 17 patients have been enrolled in the first five cohorts of the dose escalation stage (50 mg once daily, 100 mg once daily, 200 mg once daily, 350 mg once daily, and 550 mg once daily). Based on the safety profile, in March 2024 Aprea submitted an amendment to the FDA for the additional cohorts of 1100 mg and 1300 mg, with the goal of dosing patients in up to eight cohorts in total.

Preliminary signs of clinical benefit have been observed with two patients (data cutoff of March 12, 2024) achieving stable disease (SD) – one in the 50 mg once daily cohort and a second patient who showed longer duration when treated at 200 mg once daily. The latter patient at 200 mg once daily had SD at Days 55, 112, and 168. An update on the trial was featured in a poster at the AACR (Free AACR Whitepaper) Annual Meeting this past April. For further details, including the status of all patients who were enrolled at that time, refer to the AACR (Free AACR Whitepaper) poster on the Aprea corporate website here.

Initial efficacy data from Part 1 of the study may potentially be announced in 2H 2024. The Phase 1 dose escalation is expected to be completed in 4Q 2024, and RP2D is expected to be determined in 1Q 2025. Enrollment in the Phase 2a cohort is expected to begin in 1Q 2025 with additional safety and efficacy data expected in 3Q 2025.

ATRN-119 is a differentiated, potent and highly selective first-in-class macrocyclic inhibitor of ATR, a clinically validated target. It designed to be given to patients with mutations in DDR-related genes. Cancers with mutation in DDR-related genes represent a high unmet medical need and these patients have poor prognosis and, currently, have no approved effective therapies.

1 A copy of the poster that features the pharmacokinetic data on ATRN-119 presented at the AACR (Free AACR Whitepaper) Annual Meeting can be found on the Aprea corporate website here. The data demonstrate near dose proportional exposure following oral administration of ATRN-119 doses between 50 mg once daily to 550 mg once daily.

On May 28, 2024 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported the pricing of a public offering with gross proceeds to the Company expected to be approximately $12.0 million, before deducting placement agent fees and other estimated expenses payable by the Company (Press release, Applied DNA Sciences, MAY 28, 2024, View Source [SID1234643726]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The offering is comprised of 9,230,769 Units with each Unit consisting of (i) either (A) one share of common stock ("Common Share") or (B) one pre-funded warrant (the "Pre-Funded Warrant") to purchase one Common Share; (ii) one Series A Warrant to purchase one Common Share at an exercise price of $1.99 per share that will expire on the fifth anniversary of stockholder approval of the warrants (the "Series A Warrants"); and (iii) one Series B Warrant to purchase one Common Share at an exercise price of $1.99 per share or, pursuant to an alternative cashless exercise option, receive three shares of common stock. The Series B Warrant will expire on the one year anniversary of stockholder approval of the warrants (the "Series B Warrants;" together with the Series A Warrants, the "Warrants"). The Warrants cannot be exercised until their terms have been approved by the Company’s stockholders at a stockholders’ meeting.

The purchase price of each Unit with a Common Share is $1.30 and the purchase price of each Unit with a Pre-Funded Warrant will be equal to the price per Unit with a Common Share, minus $0.0001.

Applied DNA intends to use the net proceeds from this offering to further develop its Therapeutic DNA Production Services and MDx Testing Services, as well as for general corporate purposes. Applied DNA may also use a portion of the net proceeds for research and development expenses, capital expenditures, working capital and general and administrative expenses, or to fund potential acquisitions of or investments in businesses, products and technologies that complement its business; however, Applied DNA has no present commitments or agreements to make any such acquisitions or investments. This offering is expected to close on or about May 29, 2024, subject to satisfaction of customary closing conditions.

Craig-Hallum is acting as lead placement agent and Laidlaw & Company (UK) Ltd. is acting as co-placement agent for the offering.

The securities described above are being offered by Applied DNA pursuant to a registration statement on Form S-1 (File No. 333-278890) previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 the registration or qualification under the securities laws of any such state or jurisdiction. The offering is being made only by means of a written preliminary prospectus and final prospectus that will form a part of the registration statement. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Alternatively, when available, copies of the final prospectus relating to this offering may be obtained from Craig-Hallum Capital Group LLC, Attention: Equity Capital Markets, 222 South Ninth Street, Suite 350, Minneapolis, MN 55402, by telephone at (612) 334-6300 or by email at [email protected]; or from Laidlaw & Company (UK) Ltd., Attention: Syndicate Department, 521 Fifth Avenue, 12th Floor, New York, NY 10175, or by email at [email protected].