On August 4, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that on August 02, 2023, the compensation committee of BridgeBio’s board of directors granted seven new employees restricted stock units for an aggregate of 26,657 shares of the Company’s common stock (Press release, BridgeBio, AUG 4, 2023, View Source [SID1234633818]). One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2024, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the "Plan").

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The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019 and amended and restated on February 10, 2023.

On August 4, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the compensation committee of BioCryst’s board of directors granted seven newly-hired employees stock options to purchase an aggregate of 38,600 shares, and restricted stock units (RSUs) covering an aggregate of 26,450 shares, of BioCryst common stock (Press release, BioCryst Pharmaceuticals, AUG 4, 2023, View Source [SID1234633817]). The options and RSUs were granted as of July 31, 2023, as inducements material to each employee entering into employment with BioCryst. The options and RSUs were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

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The options have an exercise price of $7.39 per share, which is equal to the closing price of BioCryst common stock on the grant date. The options and RSUs vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee’s continued service with the company. Each stock option has a 10-year term. The options and RSUs are subject to the terms and conditions of BioCryst’s Inducement Equity Incentive Plan and a stock option agreement or restricted stock unit agreement, as applicable, covering the grant.

On August 4, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported the grant of 72,000 restricted stock units of Atara’s common stock to two newly hired employees (Press release, Atara Biotherapeutics, AUG 4, 2023, View Source [SID1234633816]). These awards were approved by the Compensation Committee of Atara’s Board of Directors and granted under the Atara Biotherapeutics, Inc. 2018 Inducement Plan, with a grant date of August 1, 2023, as an inducement material to the new employees entering into employment with Atara, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The restricted stock units vest over four years, with 25 percent vesting on the first quarterly vesting date after the first anniversary of the vesting commencement date and the remainder vesting in 12 approximately equal quarterly installments over the following three years, subject to the employee being continuously employed by Atara as of such vesting dates.

Atara is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

On August 4, 2023 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, reported its financial results for the quarter ended June 30, 2023, and recent business highlights (Press release, Achilles Therapeutics, AUG 4, 2023, View Source [SID1234633813]).

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"We look forward to additional clinical data in the fourth quarter of this year from our clonal neoantigen-reactive T cell (cNeT) therapy for the treatment of advanced NSCLC (CHIRON) and metastatic malignant melanoma (THETIS) and are encouraged by the improved manufacturing performance of our VELOS Process 2," said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. "We are also very excited about the developments in our AI-driven bioinformatics platform PELEUSTM. PELEUS uses a unique multi-region approach to provide validated and accurate identification of personalized clonal neoantigens. Our newly developed neoRankerTM tool is trained on a proprietary dataset of over 10,000 neoantigens and we calculate that it is potentially twice as good at identifying multiple memory T cell responses than existing deep-learning models. We believe this could be highly differentiated in the design of neoantigen vaccines and further strengthens our leadership position in the field of neoantigen identification."

Business Highlights

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Introduced and presented data at the 7th Annual Immuno-Oncology Summit Europe on the neoRankerTM tool, Achilles Therapeutics’ new immunogenicity prediction module of the AI-Powered PELEUS platform that uniquely identifies the most potent clonal neoantigens. The new AI module demonstrated potential superiority to commonly used AI tools (BigMHC) in identifying and prioritizing targets for personalized antigen approaches, supporting potential implementation into the Company’s ongoing TIL-based clinical programs in advanced non-small cell lung cancer (NSCLC) and melanoma, and into other modalities including clonal neoantigen cancer vaccines
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US patent number 11,634,773 granted on technology exclusively licensed by Achilles from the Francis Crick Institute, University College London, and Cancer Research Horizons, for selecting neoantigens that are presented by HLA molecules determined to be present in a patient’s tumor

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Regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5450(a)(1) on July 28, 2023, as confirmed by a written notice received from the Listing Qualifications Department of The Nasdaq Stock Market on July 31, 2023

Financial Highlights

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Cash and cash equivalents: Cash and cash equivalents were $143.7 million as of June 30, 2023, as compared to $173.3 million as of December 31, 2022. The Company anticipates that its cash and cash equivalents are sufficient to fund its planned operations through 2025.
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Research and development (R&D) expenses: R&D expenses were $13.8 million for the second quarter ended June 30, 2023, a decrease of $1.0 million compared to $14.8 million for the second quarter ended June 30, 2022. The decrease was primarily driven by changes to R&D priorities.
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General and administrative (G&A) expenses: G&A expenses were $4.3 million for the second quarter ended June 30, 2023, a decrease of $1.5 million compared to $5.8 million for the second quarter ended June 30, 2022. This decrease was primarily driven by changes in cost allocations, as well as lower professional fees and personnel costs.
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Net loss: Net loss for the second quarter ended June 30, 2023 was $16.8 million or $0.42 per share compared to $17.3 million or $0.44 per share for the second quarter ended June 30, 2022.

2H 2023 Focus and Upcoming Events

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Clinical Data: Report clinical and translational science data from 15 to 20 additional patients treated with cNeT monotherapy in NSCLC and melanoma, and with a cNeT/anti-PD-1 checkpoint inhibitor combination in melanoma, in the fourth quarter of the year
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Translational Science: Leverage the Company’s translational science platform to define the cNeT product features associated with clinical responses
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Clinical Activity: Drive the potential for additional confirmed responses in CHIRON and THETIS patients by delivering higher cNeT doses and improved product design
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Manufacturing Development: Continue VELOS and PELEUS development to optimize cNeT dose and functionality

Members of the Achilles team will participate in the following upcoming conferences. Additional details will be available in the Events & Presentations section of the Company’s website:

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11th Annual Immuno-Oncology Summit: August 7-9, 2023, Boston, MA
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Advanced Therapies Europe: September 6-7, 2023, Estoril, Portugal
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5th Annual TIL Therapies Summit: October 2-4, 2023, Boston, MA

On August 3, 2023 RS Oncology reported exciting new science to patients who will have the best chance of benefiting from new therapies (Press release, RS Oncology, AUG 4, 2023, View Source [SID1234633791]). PRX3 is a novel drug target with potential for treating patients with the asbestos related cancer, mesothelioma. It is a key defense against oxidative stress and is located in the mitochondria, the energy generating factories. Inhibiting PRX targets cancer, not normal cells.

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MITOPE, a first-in-human Phase 1 clinical trial, is investigating a first-in-class PRX3 inhibitor, RSO-021 (clinicaltrials.gov using the identifier NCT05278975, sponsor RS Oncology, LLC [RSO], Boston, USA). Dose escalation is ongoing across four UK sites with a planned enrollment by Q2 2024. Phase 2 expansion will bring on board additional sites in Q4 of 2023.

Early experience with RSO-021 in MITOPE was presented to a global audience of mesothelioma clinicians, scientists, and allied professionals at the 2023 International Mesothelioma Interest Group (iMig) conference hosted in Lille, France in June. The industrial symposium was entitled New Horizons for Cancer Therapy – Targeting Oxidative Stress Vulnerabilities.

Brian Cunniff, Ph.D., Chief Science Officer for RSO, and Assistant Professor of Pathology and Laboratory Medicine at the University of Vermont Cancer Center, explained how tumor cells utilize increased levels of Reactive Oxygen Species (ROS) as a driver of pro-tumor signaling pathways. He also described the discovery of PRX3 as a target to leverage ROS dependency in cancer. RSO-021 irreversibly binds and inhibits PRX3, leading to tumor-specific cell death. Dr. Cunniff stated that "RSO-021 is an exciting new therapeutic option for patients suffering with mesothelioma. RSO-021 exploits a universal vulnerability of tumor cells through a novel mechanism of action, leaving tumor cells unable to clear toxic waste products. We are excited to see our laboratory findings translated to patients in collaboration with RS Oncology."

Dr. Sean Dulloo, a UK investigator based at the University Hospitals of Leicester and University of Leicester, shared early insights in the safety and activity in MITOPE. Three cases were presented demonstrating the impactful tumor responses and reduced MPE levels with disease stabilization and improved quality of life.

Key opinion leader and IMIG 23 research medal winner, Professor Dean Fennell, also from Leicester, summarized the evolving mesothelioma treatment landscape and unmet needs. "PRX3 is a novel and interesting therapeutic drug target with potential for treating cancers, especially those with unmet need such as mesothelioma. We await the first clinical results with interest."

For more information about MITOPE clinical trial visit Mesothelioma UK. The study is supported by NIHR.