On August 8, 2022 Applied DNA Sciences, Inc., (NASDAQ: APDN) (the "Company" or "Applied DNA"), a leader in polymerase chain reaction ("PCR")-based technologies, reported the closing of its previously announced public offering of 3,000,000 shares of its common stock (or common stock equivalents in lieu thereof), together with Series A warrants to purchase up to 3,000,000 shares of its common stock and Series B warrants to purchase up to 3,000,000 shares of its common stock at a combined offering price to the public of $4.00 per share (or common stock equivalent) and associated warrants, priced at a premium to market under Nasdaq rules (Press release, Applied DNA Sciences, AUG 8, 2022, View Source [SID1234617767]). The gross proceeds to the Company from the offering were $12 million before deducting the placement agent’s fees and other offering expenses payable by the Company.

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The Series A warrants have an exercise price of $4.00 per share, are exercisable immediately upon issuance, and expire five years following the date of issuance. The Series B warrants have an exercise price of $4.00 per share, are exercisable immediately upon issuance and expire thirteen months following the date of issuance.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The offering was conducted pursuant to the Company’s registration statement on Form S-1 (File No. 333-266223) previously filed with the Securities and Exchange Commission (SEC), which became effective on August 4, 2022, and an additional registration statement filed pursuant to Rule 462(b) which became automatically effective on August 4, 2022. The offering was made only by means of a prospectus, which is part of the effective registration statements. Electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

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

On August 8, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the second quarter 2022, an update to its corporate strategy, recent business highlights, and key upcoming catalysts (Press release, Atara Biotherapeutics, AUG 8, 2022, View Source [SID1234617783]).

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"We are excited about the transformative potential of ATA188 in MS and are pleased that as a result of our significant and constructive engagement, the FDA has recommended a possible path towards a tab-cel BLA filing without the need for a new clinical study," said Pascal Touchon, President and Chief Executive Officer of Atara. "Atara’s R&D-centered strategy, clear portfolio prioritization, and purposeful partnerships are positioning us for success in reaching critical value-generating milestones for our key pipeline assets. I would like to extend my sincere gratitude and thanks to Atara’s staff for their significant contributions and unwavering commitment to advancing truly innovative medicines for patients in need."

Corporate Strategy Update

Atara announced plans to focus its activities as a leaner organization centered on R&D to further advance the Company’s innovative pipeline, while reducing cash burn
Staff will be reduced by approximately 20% across the organization
Future annual cash burn is anticipated to be reduced by over 20%, extending Atara’s cash runway into Q1 2024
Leveraging its differentiated allogeneic T-cell therapy platform and unique clinical experience in over 500 patients treated, Atara will prioritize R&D activities over the next 18 months on three core priorities:
Clinical development of ATA188, our potentially transformative Phase 2 asset for progressive multiple sclerosis
EU and potential U.S. regulatory filings and approvals for tab-cel while seeking a commercial partner for tab-cel in the U.S., including all related activities and costs, which is expected to further extend the Company’s cash runway
Anticipated Q4 2022 IND filing for ATA3219, a potential best-in-class allogeneic CD19 CAR T, with the potential to address the significant opportunity in the field for improving durable clinical response in hard-to-treat B-cell malignancies
These actions are part of a broader ongoing strategy to focus the organization on R&D, building on the previously announced manufacturing and commercialization collaborations with FUJIFILM Diosynth Biotechnologies (FDB) and Pierre Fabre, respectively, and continuing with the R&D-focused prioritization announced today
ATA188 for Progressive Multiple Sclerosis (MS)

Atara completed the Phase 2 EMBOLD study Interim Analysis (IA) in patients with progressive MS in June 2022 and the Company determined no sample size adjustment or modification would be made to the study
Based on enrollment at the end of July, approximately 90 patients are planned to be included in the read out of the study primary endpoint of confirmed disability improvement by EDSS at 12 months. Communication of these data is planned to occur at an appropriate forum in October 2023
Atara continues to plan for Phase 3 readiness, including interacting with the U.S. Food & Drug Administration (FDA) based on two Fast Track designations, and further developing its proprietary large-scale bioreactor manufacturing process
New Phase 1 MRI data providing further evidence of the potential clinical impact of ATA188 in progressive MS patients, as well as updated OLE data, are planned for presentation at an appropriate forum in Q4 2022
Tabelecleucel (tab-cel) for Post-Transplant Lymphoproliferative Disease (PTLD)

Based on constructive discussions with Atara, the FDA recommended a possible path to a Biologics License Application (BLA) submission that does not require a new clinical trial
Following planned interactions with FDA, Atara intends to provide further guidance on progress to a BLA submission at our next quarterly call
The European Medicines Agency (EMA) review of tab-cel is on-track and Atara anticipates European Commission (EC) approval in Q4 2022
Atara has successfully completed all six pre-approval inspections required to support the Marketing Authorization Application (MAA) for tab-cel in Europe
CAR T Programs

ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

Following Bayer’s strategic review and asset-level prioritization of its pipeline, the exclusive worldwide licensing agreement for next-generation mesothelin-directed CAR T-cell therapies ATA2271, an autologous version, and ATA3271, an armored allogeneic T-cell immunotherapy has been terminated
Accordingly, the IND for ATA3271 is paused pending funding for clinical development
Following the findings of the Memorial Sloan Kettering (MSK)-generated autopsy report and correlative data analyses, Atara intends to continue supporting the clinical development of ATA2271 through our collaboration with MSK and a protocol amendment to be discussed shortly with the FDA
ATA3219 (B-cell Malignancies)

Atara continues to make progress toward the anticipated IND filing for ATA3219 in Q4 2022. This allogeneic EBV CD19 CAR T program, using an optimized manufacturing process, is enriched for a memory T-cell phenotype and continues to show robust activity in preclinical studies
Second Quarter 2022 Financial Results

Cash, cash equivalents and short-term investments as of June 30, 2022 totaled $331.3 million, as compared to $301.8 million as of March 31, 2022. The increase includes the impact of net proceeds of $94.8 million from the sale of the ATOM facility during the second quarter
Atara believes that its cash and investments as of June 30, 2022, together with the expected reductions in operating cash burn, will be sufficient to fund the Company’s planned operations into the first quarter of 2024
Net cash used in operating activities was $64.0 million for the second quarter 2022, as compared to $61.6 million for the same period in 2021
Atara reported net income of $18.5 million, or $0.18 per share, for the second quarter 2022, as compared to a net loss of $83.8 million, or $0.91 per share, for the same period in 2021. Second quarter 2022 net income included a gain on the sale of the ATOM facility of $50.2 million.
License and collaboration revenue was $51.6 million for the second quarter 2022, primarily consisting of deferred revenue recognized due to the termination of the Bayer Collaboration Agreements, as compared to $3.9 million for the same period in 2021. We anticipate that license and collaboration revenues will decrease substantially in future quarters due to the termination of the Bayer Agreements.
Total operating expenses include non-cash expenses of $15.6 million for the second quarter 2022, as compared to $16.1 million for the same period in 2021
Research and development expenses were $64.9 million for the second quarter 2022, as compared to $68.5 million for the same period in 2021
The decrease in the second quarter 2022 was primarily due to lower employee-related and overhead costs as a result of the FDB transaction, partially offset by increased spending on the Company’s ATA188 and CAR T programs
Research and development expenses include $7.9 million of non-cash stock-based compensation expenses for the second quarter 2022 as compared to $8.3 million for the same period in 2021
General and administrative expenses were $18.8 million for the second quarter 2022, as compared to $19.4 million for the same period in 2021
General and administrative expenses include $6.2 million of non-cash stock-based compensation expenses for the second quarter 2022, as compared to $5.5 million for the same period in 2021
Conference Call and Webcast Details

Atara will host a live conference call and webcast today, Monday, August 8, 2022, at 4:30 p.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13730293. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company’s website for 30 days following the live webcast.

On August 8, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy (Press release, Tracon Pharmaceuticals, AUG 8, 2022, View Source [SID1234617799]).

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The Phase 1/2 trial will assess the safety and efficacy of YH001 and envafolimab with or without doxorubicin in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma and in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma.

"With the submission of the IND, we are one step closer to bringing our triple combination of YH001, envafolimab and doxorubicin to front-line sarcoma patients, and pending clearance of the IND, we look forward to initiating the trial before end of this year," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer.

About YH001

YH001, an IgG1 antibody against CTLA-4 invented by Biocytogen, the parent company of Eucure Biopharma, and licensed by TRACON, has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 has been dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

About the Phase 1/2 Clinical Trial of YH001, envafolimab and doxorubicin (NCT05448820)

The Phase 1/2 clinical trial is a multicenter, open label study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by Phase 2 cohorts of patients with select histologies of advanced or metastatic sarcoma, including treatment naive patients. The primary objective of the Phase 1 portion of the trial is to determine the recommended phase 2 dose of YH001 in combination with envafolimab and in combination with envafolimab with doxorubicin. The primary objective of the Phase 2 portion is to determine the objective response rate (ORR) of the combination of YH001 and envafolimab in patients with alveolar soft part sarcoma and chondrosarcoma and the ORR of the combination of YH001, envafolimab and doxorubicin in patients with leiomyosarcoma and dedifferentiated liposarcoma.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

On August 8, 2022 Pyramid Biosciences, Inc., a Boston-based, clinical-stage biotechnology company focused on developing new and highly differentiated precision therapies for cancer and other serious diseases, reported the expansion of its senior leadership team (Press release, Pyramid Biosciences, AUG 8, 2022, View Source [SID1234617814]). Nushmia Khokhar, MD has joined the company as Chief Medical Officer, where she will oversee the advancement and expansion of the Company’s clinical pipeline.

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"Dr. Khokhar has a proven track record of successfully bringing novel oncology compounds through clinical development to global approval," said CEO of Pyramid Biosciences, Brian Lestini, MD, PhD. "We are looking forward to Dr. Khokhar’s leadership of our clinical programs during this important growth stage of our company."

Prior to joining Pyramid Biosciences, Dr. Khokhar served as Chief Medical Officer at Umoja Biopharma, a multi-platform, immuno-oncology company based in Seattle, WA. In this capacity, Dr. Khokhar oversaw Umoja’s clinical development, operations, and regulatory functions. Prior to joining Umoja, Dr. Khokhar was the Senior Vice President & Head of Clinical Development at Autolus Therapeutics, where she played a critical role in advancing the company’s autologous CAR T-cell products and clinical programs. Prior to that, Dr. Khokhar held numerous roles at Janssen Oncology, a subsidiary of Johnson & Johnson (NYSE: JNJ) where she led several successful clinical trials, directed the Phase 3 registration trial of trabectedin (YONDELIS) in soft tissue sarcomas, and served as the Global Clinical Leader for the breakthrough therapy daratumumab (DARZALEX) for hematologic cancers.

"I look forward to working with the outstanding team at Pyramid Biosciences, progressing the Company’s promising therapies through clinical development and building a robust pipeline," said Dr. Khokhar.

"We are extremely pleased to have Nushmia join our senior leadership team as we continue to grow our clinical programs and develop new medicines for underserved patients," said Jordan Leef, Pyramid Biosciences’ Co-Founder & COO.

Dr. Khokhar is a graduate of Aga Khan University and completed her post-doctoral fellowship at Memorial Sloan-Kettering Cancer Center, where she focused on pharmacology and molecular therapeutics. Following her post-doctoral fellowship, Dr. Khokhar completed a residency in internal medicine at Washington Hospital Center and a fellowship in Hematology/Oncology at the Northwestern University Hospital. Dr. Khokhar is board certified in medical oncology.

On August 8, 2022 Chugai Pharmaceutical Co., Ltd. (Headquarters: Tokyo, Japan, hereafter Chugai) reported that Chugai, Roche and Genentech (collectively "the Companies") have entered into a settlement agreement with Fresenius Kabi USA, LLC (hereafter, Fresenius) on August 5, 2022 relating to the patent lawsuit filed by the Companies on March 19, 2020 (Press release, Chugai, AUG 8, 2022, View Source [SID1234617729]). In the lawsuit, the Companies alleged that the submission of an Abbreviated New Drug Application ("ANDA") by Fresenius for a generic version of Alecensa (generic name: alectinib, an ALK inhibitor, anti-cancer agent) to the U.S. Food and Drug Administration infringed Chugai’s patents in the U.S. (Nos. 9,126,931; 9,440,922; 9,365,514 and 10,350,214) under the framework of the Drug Price Competition and Patent Term Restoration Act (known as Hatch-Waxman Act). In accordance with the settlement agreement, the Companies and Fresenius will take steps to withdraw the lawsuit.

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Lawsuit filed at the United States District Court for the District of Delaware
Dates of Complaint: March 19, 2020 (U.S. Eastern Standard Time)
Defendant: Fresenius Kabi USA, LLC
Patents in suit: U.S. Patent Nos. 9,126,931; 9,440,922; 9,365,514 and 10,350,214

The impact on the consolidated financial results for the fiscal year ending December 2022 of Chugai is expected to be negligible.