On May 9, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, reported that the Company will host a conference call at 11:00 a.m. ET on Monday, May 16, 2022 to discuss financial results for the first quarter ended March 31, 2022 and provide an update on product development programs with GEN-1, a DNA-based immunotherapy, currently in Phase II development for the localized treatment of advanced ovarian cancer and PLACCINE, a proprietary synthetic, non-viral vaccine delivery technology currently in preclinical studies (Press release, Celsion, MAY 9, 2022, View Source [SID1234613952]). Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and next generation infectious vaccines.

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To participate in the call, interested parties may dial 1-888-394-8218 (Toll-Free/North America) or +1-323-794-2588 (International/Toll) and ask for the Celsion Corporation First Quarter 2022 Earnings Call (Conference Code: 7615593) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Monday, May 16, 2022, and will remain available until May 30, 2022. The replay can be accessed at +1-719-457-0820 or 1-888-203-1112 using Conference ID: 7615593. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. ET Monday, May 16, 2022.

On May 9, 2022 Dragonfly Capital ("Dragonfly"), a global crypto-focused investment firm, reported the final closing of its third venture fund, Dragonfly Ventures III, L.P. ("Fund III") with capital commitments from limited partners of $650 million, exceeding the Fund’s original target of $500 million (Press release, Dragonfly Therapeutics, MAY 9, 2022, View Source [SID1234613969]). The oversubscribed fund was closed at its hard cap and received strong support from institutional limited partners including leading Ivy League endowments, KKR, Tiger Global, Sequoia China, Invesco, US pensions, and sovereign wealth funds.

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Dragonfly previously closed Dragonfly Ventures II in 2021 after raising over $250 million. The new fund enhances the firm’s capacity to invest across all stages of blockchain and cryptocurrency companies, native protocols, and tokens that seek to create new digital economies. Dragonfly will build on the team’s investment track record and its global, technologist first approach to investing in crypto companies.

"Dragonfly has always been different because of two things: our global approach to investing, which reflects the borderless nature of crypto, and our technical bent, as most of our team understands crypto technology from first principles. In Fund III, we will double down on backing the next breakthroughs in crypto infrastructure, DeFi, smart contract scaling, and breakthrough consumer products like NFTs, crypto games, and DAOs. It’s an exciting moment in the history of web3 and we’re eager to partner with the next generation of builders," said Haseeb Qureshi, Managing Partner at Dragonfly.

"We’re looking forward to continuing to do what we love – working closely with founders at the very earliest stages to build generational companies in crypto. Most of our investment team previously worked at crypto startups and we lean on this hands-on experience to help entrepreneurs navigate the difficult parts of creating amazing companies in this space," said Tom Schmidt, General Partner at Dragonfly.

Since its inception in 2018, Dragonfly has established a strong track record and invested over $700 million of capital across seed, series A, series B, and liquid crypto deals. To date, the firm has made early investments in many top projects and companies, including Avalanche, NEAR Protocol, Compound, MakerDAO, 1inch, Matter Labs, Amber Group, Anchorage, Bybit, and Dune Analytics.

On May 9, 2022 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on its proprietary tRNA synthetase biology platform, reported first quarter 2022 results and provided a corporate update (Press release, aTyr Pharma, MAY 9, 2022, View Source [SID1234614113]).

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"We are pleased with the start of 2022 and the continued progress throughout the first quarter for our efzofitimod clinical program in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "With the receipt of U.S. Food and Drug Administration (FDA) orphan drug designation and a positive End-of-Phase 2 meeting with the FDA, we are on track to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of this year."

"The second quarter is shaping up to be an important period, as we prepare to present the clinical data for the Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis at the upcoming American Thoracic Society (ATS) International Conference and anticipate the potential publication of a related manuscript. We are focused on preparation for the planned registrational study so that the balance of the year may center upon initiating the study in the U.S. and Europe and supporting our partner Kyorin Pharmaceutical with the anticipated launch of the study in Japan."

First Quarter 2022 and Subsequent Period Highlights

Announced posters accepted for presentation for efzofitimod in pulmonary sarcoidosis at the upcoming ATS 2022 International Conference. The posters will present clinical data from the recently completed Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety, tolerability and consistent dose response for efzofitimod on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.
Announced a company reception at the upcoming ATS 2022 International Conference in San Francisco, CA, on Monday, May 16, 2022. The event, which will convene sarcoidosis medical experts, principal investigators, advocacy organizations, analysts and investors, will review results from the Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis and discuss an outlook for the planned registrational study that the company expects to initiate in the third quarter of 2022.
Received FDA orphan drug designation for efzofitimod for the treatment of systemic sclerosis (SSc, or scleroderma), a chronic, progressive autoimmune disease in which many patients may develop associated ILD, known as SSc-ILD. Orphan drug designation is granted to support the development of medicines for patients with unmet needs for rare disorders affecting fewer than 200,000 people in the U.S. and provides certain benefits, including the potential for seven years of market exclusivity following regulatory approval. The company expects to explore the potential expansion of its efzofitimod clinical program into other forms of ILD with high unmet medical need.
Presented preclinical research in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting characterizing the effects of ATYR2810, the company’s lead anti-Neuropilin-2 (NRP2)/VEGF antibody and IND candidate, in highly aggressive tumor subtypes, including triple-negative breast cancer. The findings suggest that ATYR2810 reduces metastasis and enhances chemosensitivity by downregulating key genes linked to these processes. The company expects to initiate a phase 1 study of ATYR2810 in cancer patients in the second half of 2022.
First Quarter 2022 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents and investments as of March 31, 2022, were $98.7 million.
R&D Expenses: Research and development expenses were $8.9 million for the first quarter of 2022, which consisted primarily of product development and manufacturing costs for the efzofitimod and ATYR2810 programs.
G&A Expenses: General and administrative expenses were $3.5 million for the first quarter of 2022.
Shares Outstanding: Common shares outstanding were 28,056,249 as of March 31, 2022.
Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. EDT / 2:00 p.m. PDT to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the U.S., or 209-905-5951 internationally and using conference ID 9273437. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source An audio replay will be available for at least 90 days following the event.

About Efzofitimod

aTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease. Efzofitimod, a fusion protein comprised of the immunomodulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates innate and adaptive immune response in inflammatory disease states. aTyr’s lead indication for efzofitimod is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for efzofitimod was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose response and trends of benefit of efzofitimod compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers. aTyr intends to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of 2022.

On May 9, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported partnerships with prominent next generation sequencing (NGS) providers and leaders in genomic testing and profiling, including Foundation Medicine, Tempus and others (Press release, Aadi Bioscience, MAY 9, 2022, View Source [SID1234614205]). We expect these collaborations to expedite patient identification for the ongoing PRECISION 1 trial of nab-sirolimus in patients harboring tumors with inactivating alterations in TSC1 or TSC2 genes.

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Neil Desai, PhD, Founder, President and Chief Executive Officer of Aadi, stated, "We are very pleased to have these leading NGS partnerships in place. Recently published data project an incidence of approximately 12,000 advanced cancer patients with TSC1 or TSC2 definite impact alterations in the US. These collaborations should help physicians to identify patients who may be candidates for nab-sirolimus in our PRECISION 1 registrational trial. We expect to report preliminary data from this trial in the first half of next year."

Loretta Itri, M.D., Chief Medical Officer of Aadi, stated, "We are excited to announce partnerships with the leading molecular diagnostic companies, including Foundation Medicine, Tempus and others. Many of our clinical trial sites had already been utilizing the NGS reports provided by these companies. Now our partnerships will allow us to also leverage their established patient enrollment programs, which we believe will significantly augment our efforts to identify and recruit patients with TSC1 and TSC2 alterations for our PRECISION 1 registrational trial. We are pleased with our progress to-date and remain confident we will meet our enrollment goals."

These partners will collect and analyze clinical and molecular data to determine which patients may be eligible to participate in Aadi’s PRECISION 1 clinical trial. The goals are to increase patient match rate, reduce screen failure rate and increase speed of enrollment into the trial.

About the PRECISION 1 Trial

The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic pivotal study, of nab-sirolimus designed as a basket trial that will evaluate approximately 120 adult and adolescent patients with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial will have two independent arms of 60 patients each to separately evaluate patients with either TSC1 or TSC2 inactivating alterations. Aadi has received Fast Track designation to evaluate nab-sirolimus in this indication from the FDA. The first patient on the PRECISION 1 trial was dosed in March 2022.

On May 8, 2022 AskGene Limited ("AskGene"), a clinical-stage biopharmaceutical company focusing on discovery and development of innovative biological drugs, reported the completion of USD 20 million in Series A financing (Press release, AskGene Pharmaceuticals, MAY 8, 2022, View Source [SID1234613849]). The financing was led by Qiming Venture Partners and TF Capital. Proceeds from the financing will be used to advance clinical development of AskGene’s robust pipeline of innovative therapeutic candidates and development of SmartKine cytokine prodrug platform.

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Cytokines are well validated co-stimulators and hold great promise in immunotherapy, however, they have short half-lives, severe systemic toxicity and narrow therapeutic windows. SmartKine is a transformational cytokine technology platform developed by AskGene with global intellectual property rights. The technology overcomes the limitations of current cytokine therapeutics, brings next-generation cytokine therapies to patients with unmet medical needs. SmartKine molecules are designed to selectively activate a subset of immune cells preferentially at a disease site to enhance the function selectivity, developability and therapeutic indexes of cytokines.

"We are very pleased to have support from first-class investors who share our vision to modulate immune system at disease sites with precision," said Jeff Lu, Chief Executive Officer of AskGene Limited. "This is an exciting time for our company. We are advancing several potentially first-in-class or best-in-class molecules from our SmartKine platform to preclinical development and clinical development later this year. In addition, our clinical programs ASKB589 and ASKG712 are progressing smoothly. We look forward to promising results from multiple clinical programs later this year and next year."

"Cancer is still one of the major disease burdens for patients and IO has demonstrated its effectiveness", stated William Hu, Managing Partner of Qiming Venture Partners, "AskGene’s team shows deep understanding in IO and protein engineering. We believe their proprietary platform continues to generate more pipelines to clinic and market."

Allan Liu, Director at TF Capital commented: "Application of immunostimulatory cytokines has become a promising approach in cancer immunotherapy, however unfavorable PK and safety profile limit their further clinical development and application. AskGene’s proprietary SmartKine platform can overcome limitations of first-generation recombinant cytokines by achieving conditional activation of cytokines in the tumor microenvironment to unleash the full therapeutic potential. We are thrilled to partner with AskGene’s exceptional leadership team as they advance SmartKine molecules into the clinic with the ultimate goal of providing better outcomes to cancer patients."