On May 9, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended March 31, 2022 (Press release, ORIC Pharmaceuticals, MAY 9, 2022, View Source [SID1234613920]).

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"We continue to make steady progress in advancing our pipeline of novel oncology candidates," said Jacob M. Chacko, MD, chief executive officer, "We expect to report initial data from our three ongoing studies in the first half of 2023, which includes our Phase 1b single agent trials for ORIC-533, our orally bioavailable CD73 inhibitor, ORIC-114, our brain penetrant EGFR/HER2 inhibitor, and ORIC-944, our embryonic ectoderm development (EED) inhibitor."

First Quarter 2022 and Other Recent Highlights

Preclinical Data Presented at AACR (Free AACR Whitepaper): In April 2022, ORIC disclosed new preclinical data in three poster presentations and one oral presentation at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

ORIC-533: Oral Small Molecule CD73 Inhibitor
ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73 that has demonstrated more potent adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule inhibitors of the adenosine pathway. In preclinical studies, ORIC-533 overcame immune suppression and triggered significant lysis and cell death of multiple myeloma cells in an assay comprised of autologous bone marrow microenvironment. A Phase 1b trial with ORIC-533 as a single agent in multiple myeloma is enrolling patients, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-114: EGFR/HER2 Inhibitor
ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. In preclinical studies, ORIC-114 achieved tumor regressions in an EGFR exon 20 NSCLC model with superior efficacy relative to CLN-081 and demonstrated greater anti-tumor activity compared to mobocertinib (TAK-788) in an intracranial NSCLC model. A Phase 1b trial with ORIC-114 as a single agent is enrolling patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and allows for patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-944: PRC2 Inhibitor
ORIC-944 is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2) that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. A Phase 1b trial with ORIC-944 as a single agent is enrolling patients with metastatic prostate cancer, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

PLK4 Inhibitor Program
In March, the company announced a small molecule therapeutic program intended to address a mechanism of innate resistance found in a subset of breast cancers, specifically a synthetic lethal interaction of polo-like kinase 4 (PLK4) inhibition in tumors bearing a TRIM37 DNA amplification. ORIC discovered novel, potent, orally bioavailable small molecule inhibitors of PLK4 that are highly selective and achieved strong anti-tumor activity of TRIM37 high xenograft tumors, with corresponding pharmacodynamic effects and no body weight loss. The PLK4 inhibitor program is currently in lead optimization.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

ORIC-533: Initial Phase 1b data in 1H 2023
ORIC-114: Initial Phase 1b data in 1H 2023
ORIC-944: Initial Phase 1b data in 1H 2023
First Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $256.2 million as of March 31, 2022, which the company expects will fund its current operating plan into the second half of 2024.
R&D Expenses: Research and development (R&D) expenses were $16.8 million for the three months ended March 31, 2022, compared to $11.7 million for the same period in 2021, an increase of $5.1 million. The increase was primarily driven by an increase in external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and our other product candidates of $4.6 million, offset by a decrease in ORIC-101 costs of $0.7 million due to the discontinuation of the program in the first quarter of 2022. Higher internal expenses related to higher personnel costs, including additional non-cash stock-based compensation of $0.5 million, also contributed to the increase in research and development expenses.
G&A Expenses: General and administrative (G&A) expenses were $6.4 million for the three months ended March 31, 2022, compared to $4.9 million for the same period in 2021, an increase of $1.6 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.7 million.

On May 9, 2022 Labcorp (NYSE: LH), a leading global life sciences company, and AtlantiCare, the largest health care organization in southern New Jersey, reported that they have closed a transaction to expand their long-term strategic relationship (Press release, LabCorp, MAY 9, 2022, View Source [SID1234613936]). Labcorp will acquire select assets from AtlantiCare’s clinical outreach business, which serves the AtlantiCare Physician Group and Affiliated Physicians and their patients across southern New Jersey. The transaction is the latest in a series of new and expanded collaborations between Labcorp and health systems across the country, demonstrating the value that Labcorp brings to improve laboratory services and help enhance patient care.

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"Labcorp is keenly focused on delivering value to our health system partners, physicians, and the broader community," said Bill Haas, senior vice president of Labcorp’s Northeast Division. "Our multi-year, comprehensive relationship with AtlantiCare is a prime example of that focus. Through this enhanced outreach relationship, Labcorp is furthering its commitment to AtlantiCare’s patients and providers to improve health and improve lives in the region, including through increased diagnostic testing access."

AtlantiCare’s patients will be able to access Labcorp’s expansive test menu and services through the company’s extensive network of patient service centers including Labcorp at Walgreens. Many of AtlantiCare’s physician office phlebotomy sites and outpatient collection services will now be operated by Labcorp.

"As a health system, we are committed to evolving the care and services we provide," said Lori Herndon, MBA, BSN, RN, president and CEO of AtlantiCare. "Our past collaboration with Labcorp has helped us provide comprehensive testing services to meet the growing needs of our community. Most recently, this has included Labcorp’s ability to provide critical testing, collections, lab equipment and supplies throughout the pandemic. This collaboration will enhance the breadth and quality of laboratory services patients and healthcare providers have come to expect from both of our organizations."

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.