On May 16, 2022 NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that strategic, financial, and operational updates for the first quarter ended March 31, 2022 (Press release, NightHawk Biosciences, MAY 16, 2022, View Source [SID1234614707]).

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Jeff Wolf, Chief Executive Officer of NightHawk, commented, "We are extremely proud of the progress we have made this quarter to transition NightHawk into a fully-integrated biopharmaceutical company. On the business front, this month we announced the name change to NightHawk Biosciences to better reflect our evolution towards a fully integrated ecosystem that enables more rapid delivery of medical innovations with increased quality and efficiency. The NightHawk ecosystem includes an expanded development pipeline and enhanced manufacturing capabilities around five key subsidiaries: Skunkworx Bio, Heat Biologics, Pelican Therapeutics, Elusys Therapeutics and Scorpion Biological Services."

"Moreover, we recently closed the strategic acquisition of Elusys Therapeutics (Elusys), which significantly expands our foothold in the biodefense space. The addition of Elusys’ ANTHIM, a treatment for inhalation anthrax, complements our infectious disease product portfolio, which includes our RapidVax platform, which is designed to target emerging biological threats. Shortly after the completion of the Elusys acquisition, we finalized our first international contract with the Canadian government to deliver ANTHIM to their national stockpile. We are now pursuing additional opportunities to expand ANTHIM distribution abroad."

"At the same time, we continue to expand our biomanufacturing and bioanalytic capabilities. We recently unveiled plans for a new 500,000 square foot commercial/biodefense biomanufacturing facility in Manhattan, Kansas. In addition to servicing our own product pipeline, we plan to operate as a full-service Contract Development and Manufacturing Organization (CDMO) to support other biopharma companies. Moreover, we remain on track for the grand opening of our San Antonio facility in Q2/22."

Mr. Wolf added, "The NightHawk ecosystem is truly unique among small biopharmaceutical companies. We look forward to providing further updates on our progress later this year."

First Quarter 2022 Financial Results

Recognized $0.2 million of grant revenue for qualified expenditures under the CPRIT grant for the quarter ended March 31, 2022 compared to $0.5 million for the quarter ended March 31, 2021. The decrease in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of March 31, 2022, we had a grant receivable balance of $1.5 million for CPRIT proceeds not yet received but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
Research and development expenses were $3.9 million for the three months ended March 31, 2022 compared to $3.4 million for the three months ended March 31, 2021. The increase was primarily due to regulatory consulting and investigator site payments for the ongoing Phase 1 clinical trial for HS-130 as well as unallocated research expenses related to personnel costs, including stock-based compensation from stock awards.
General and administrative expense was $3.8 million and $4.8 million for the quarters ended March 31, 2022 and 2021. The decrease was due to a decrease in stock-based compensation expense of $2.0 million, partially offset by increased personnel costs of $0.2 million, and increases of $0.3 million for consulting and other professional expenses to manage the business.
Net loss attributable to NightHawk Biosciences was approximately $8.1 million, or ($0.32) per basic and diluted share for the three months ended March 31, 2022 compared to a net loss of approximately $7.5 million, or ($0.31) per basic and diluted share for the three months ended March 31, 2021.
As of March 31, 2022, the Company had approximately $84.1 million in cash, cash equivalents and short term investments.

On May 16, 2022 NETRIS Pharma, a clinical-stage immuno-oncology pharmaceutical company pioneering dependence receptors-based drug discovery and development, reported that CEO and Founder Patrick Mehlen, and CFO Christophe Guichard, will be attending the Bio International Convention taking place June 13-16, 2022, in San Diego, CA (Press release, Netris Pharma, MAY 16, 2022, View Source [SID1234614706]).

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On May 16, 2022 RadNet, Inc., (NASDAQ: RDNT) reported that it has received FDA clearances for its DeepHeatlh Saige-DX mammography and Quantib Prostate 2.0 MRI artificial intelligence ("AI") algorithms (Press release, RadNet, MAY 16, 2022, View Source [SID1234614705]).

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Saige-DX: AI Mammography Diagnostic Software

Saige-Dx, a more advanced successor to our FDA approved Saige-Q worklist triage software, is a cancer detection tool that enables radiologists to more effectively detect the presence or absence of breast cancer with the use of artificial intelligence. DeepHealth’s powerful new AI technology automatically identifies suspicious lesions in mammograms and assigns a suspicion level to each finding and to the entire case. It helps detect and diagnose breast cancer earlier while reducing unnecessary recalls.

"In our study to support FDA clearance, all 18 radiologists who participated exhibited improved performance when using Saige-Dx, resulting in the largest increase in performance across all mammography AI products on the market to date. The improved performance was reflected in both an increase in the percentage of the cancers detected and a lower false positive rate when using Saige-Dx," said Bill Lotter, Ph.D., CTO, and co-founder of DeepHealth.

"Saige-Dx is built on our advanced deep-learning algorithms. Our highly accurate AI, as is described in a Nature Medicine article last year, showed the ability to find cancer one to two years earlier than fellowship-trained breast imaging radiologists. The approval of Saige-Dx represents another step forward in advancing cancer care. The feedback from physicians who have worked with our software tools is overwhelmingly positive, making them more accurate and efficient at interpreting mammography images," said Gregory Sorensen, M.D., CEO, and co-founder of DeepHealth.

Quantib Prostate 2.0: An AI Powered Solution for Prostate MRI Reading and Reporting

Quantib Prostate is an AI-based software solution that advances the MRI prostate reporting workflow and is accessible directly from the radiologist’s reading station. The solution comes with a suite of tools to improve reporting quality and speed, including AI-based segmentations and volumetry, PSA density calculation, precise registration and movement correction, one-click segmentation of lesion candidates, PI-RADS scoring support, and standardized reporting to facilitate easy and comprehensive communication of results. FDA 510k special clearance has been given for a major upgrade to the solution (from release 1.3) that now includes fully automatic prostate zone segmentation (in addition to prostate gland segmentation) and automated initiation of localization of lesions on the PI-RADS sector map.

"We are delighted to present this update of Quantib Prostate, including a selection of new features that our customers requested over the past few months. We seek to continuously improve our software to support radiologists and urologists in the best way possible, and we deliver updated solutions to our customers as quickly as possible," said Arthur Post Uiterweer, CEO of Quantib.

Dr. Howard Berger, President and Chief Executive Officer of RadNet, said, "We are very proud that two of our subsidiaries, DeepHealth and Quantib, have received FDA clearance for their flagship products. Artificial intelligence will have a transforming impact on radiology and cancer care, and we are committed to delivering those advances to patients and healthcare providers. These recent approvals will help us drive improved patient outcomes while lowering costs. The Biden administration, through its Cancer Moonshot program, is committed to significantly reducing the mortality rates from cancer in the coming decades. We believe that these AI tools will play an important role in the early detection and diagnosis of cancer, resulting in improved survival rates and better patient outcomes."

On May 16, 2022 Exicure, Inc. (NASDAQ: XCUR), an early-stage biotechnology company focused on the development of next generation nucleic acid therapies targeting RNA to address both genetic and non-genetic neurological disorders and hair loss disorders, reported financial results for the quarter ended March 31, 2022 and provided an update on its business strategy and corporate progress (Press release, Exicure, MAY 16, 2022, View Source [SID1234614704]).

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"Exicure is off to a promising start in 2022 as we have made progress with our preclinical SCN9A program for the treatment of pain with several potential therapeutic candidates identified and we are conducting initial in vivo animal studies to support candidate selection in 2023," commented Matthias Schroff, Ph.D., Chief Executive Officer of Exicure. "We continue to advance our partnered programs with Ipsen and AbbVie, and the recently announced private placement investment led by CBI USA, Inc. ("CBI USA") is expected to provide us with additional resources as we continue our mission to pursue treatments for patients with unmet medical needs," concluded Dr. Schroff.

Corporate Progress

Recent highlights include:

On May 10, 2022, Exicure announced a $5.0 million raise in a private placement transaction priced at market premium
Agreed to sell an aggregate of 26,021,011 shares of the Company’s common stock to certain accredited investors in a private placement in public equity ("PIPE") financing at a purchase price of $0.1937 per share, representing an approximately 45% premium to the 10-day volume weighted-average share price from May 9, 2022.
New investor CBI USA led the transaction; existing investor, Abingworth LLP, also participated.
Transaction is expected to close on or about May 19, 2022, subject to the satisfaction of customary closing conditions.
In connection with the PIPE, CBI USA received the right to nominate a member to the Company’s board of directors (the "Board"), effective as of the closing date. CBI USA will also have the right to designate one individual to attend all meetings of the Board in a nonvoting observer capacity.
Net proceeds from the transaction expected to support the Company’s advancement of its preclinical program, including the development of its SCN9A product candidate, as well as other working capital and general corporate purposes.
Corporate highlights for the first quarter of 2022 include:

Repaid in full all outstanding indebtedness and other obligations under the Company’s credit facility with MidCap, effective March 15, 2022.
Continued to advance the Company’s SCN9A preclinical discovery program. Exicure anticipates results from initial in vivo animal studies by year-end 2022, with the goal of therapeutic candidate selection in the second half of 2023.
Progressed work with partnered programs towards potential pre-clinical milestones in 2023.
Actively pursuing out-license opportunities for the Company’s clinical asset, cavrotolimod.
Continuing to pursue near-term partnering opportunities for pain and other neuroscience programs.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and short-term investments were $27.6 million as of March 31, 2022, as compared to $48.3 million as of December 31, 2021. The Company expects that its cash and cash equivalents, together with the expected $5.0 million gross proceeds from the PIPE transaction in May 2022, will enable it to fund its current operations into the first quarter of 2023.

Revenue: Revenue was $2.6 million for the quarter ended March 31, 2022, reflecting an increase of $1.6 million from revenue of $1.0 million for the quarter ended March 31, 2021. The increase in revenue of $1.6 million is mostly due to the recognition of non-cash revenue of $2.1 million associated with the Company’s collaboration with Ipsen Biopharm Limited, partially offset by a decrease in revenue of $0.5 million associated with the Company’s collaboration with AbbVie Inc.

Research and Development (R&D) Expense: Research and development expenses were $7.1 million for the quarter ended March 31, 2022, as compared to $10.3 million for the quarter ended March 31, 2021. The decrease in R&D expense for the three months ended March 31, 2022 of $3.1 million reflects a reduction in employee headcount and fewer discovery, preclinical, and clinical program activities resulting from the restructuring activities that the Company announced in December 2021.

General and Administrative (G&A) Expense: General and administrative expenses were $3.2 million for the quarter ended March 31, 2022, as compared to $2.9 million for the quarter ended March 31, 2021. The increase in G&A expense of $0.3 million for the three months ended March 31, 2022 was mostly due to higher legal costs and retention award expense for current employees, partially offset by a decrease in recruiting costs, investor relations costs, and stock-based compensation.

Net Loss: The Company had a net loss of $8.3 million for the quarter ended March 31, 2022, as compared to a net loss of $12.5 million for the quarter ended March 31, 2021. The decrease in net loss was primarily driven by lower R&D expense and higher non-cash revenue during the period.

Going Concern: Given the Company’s current cash position, operating plans and forecasted negative cash flows from operating activities over the next twelve months, management believes there is substantial doubt regarding the Company’s ability to continue as a going concern within one year after the date that its unaudited condensed consolidated financial statements for the quarter ended March 31, 2022 are issued. The Company will require substantial additional financing to address the Company’s working capital and other financing needs to pursue its business strategy.

On May 16, 2022 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company with a Research & Development ("R&D") innovation engine that aims to discover, develop and ultimately deliver impactful medicines to patients, reported financial results for the first quarter ended March 31, 2022 and provided business updates (Press release, Centessa Pharmaceuticals, MAY 16, 2022, View Source [SID1234614702]).

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"We continue to execute against our focused strategy and advance our pipeline of innovative, high impact rare disease and immuno-oncology assets that we believe will position Centessa for multiple value-creating milestones through our extended cash runway. Our model is focused on judicious capital and resource allocation decisions which, combined with our strong balance sheet, provide us with significant optionality to meet our ‘4×24’ goal of four registrational programs in 2024," said Saurabh Saha, MD, PhD, Chief Executive Officer of Centessa. "Our most advanced program, lixivaptan for ADPKD, continues to progress in the ongoing registrational ACTION Study. In addition, ZF874 for AATD is on track for data later this year from the ongoing Phase 1 study, we continue to anticipate SerpinPC in Hemophilia to enter registrational trials this year, and we recently commenced dosing in the Phase 1 study of CBS001, an anti-LIGHT monoclonal antibody. In the near term, we are excited to share initial preclinical data for LB101, our PD-L1xCD47 LockBody at ASCO (Free ASCO Whitepaper) 2022 in June."

First Quarter 2022 Highlights and Recent Business Updates
Clinical Development Programs:
•SerpinPC: Based on the FDA feedback received in the first quarter of 2022, the Company is proceeding with a streamlined, integrated registrational development plan initially for Hemophilia B (with and without inhibitors).
•Lixivaptan: Commenced dosing in the pivotal Phase 3 clinical trial ("ACTION Study") evaluating lixivaptan as a potential treatment for ADPKD. In addition, a key US patent was issued on

February 8, 2022, which covers the use of lixivaptan for the treatment of ADPKD. The patent term expires June 8, 2038, before considering possible patent term extensions or adjustments.
•CBS001 in inflammatory / fibrotic diseases: Commenced dosing of healthy volunteers in a Phase 1 study of CBS001, a high affinity anti-LIGHT monoclonal antibody.

Business Highlights:
•During the first quarter of 2022, the Company named Antoine Yver, MD, MSc, Executive Vice President and Chairman of Development; Javad Shahidi, MD, MSc, Chief Medical Officer; and Josh Hamermesh, MBA, Senior Vice President, Business Development.
•In March 2022, the Company announced ‘4×24’, its corporate goal to have four registrational programs in 2024.
•In March 2022, the Company announced plans to discontinue the small molecule EGFR inhibitor discovery programs (PearlRiver Bio) and the dual-STAT3/5 degrader program (Janpix Limited) and is now winding down operations at both subsidiaries. The Company also continues to evaluate strategic options, including potential divestment, for imgatuzumab (Pega-One).
•In February 2022, dosing of the first patient with lixivaptan in the Phase 3 ACTION Study triggered settlement of the contingent value rights ("CVRs") originally issued to the former shareholders and option holders of Palladio Biosciences in connection with its acquisition by Centessa in January 2021.

Anticipated Upcoming Program Milestones
•LB101 in Solid Tumors: Preclinical data for LB101, a PD-L1xCD47 LockBody, will be presented in a poster at ASCO (Free ASCO Whitepaper) 2022 on June 5, 2022. An IND for LB101 is planned for late 2022.
•ZF874 in Alpha-1 Antitrypsin Deficiency (AATD): The Company expects to share data from the ongoing Phase 1 study in the second half of 2022. This interim data will include multiple dose cohorts with PiMZ and PiZZ subjects.
•SerpinPC in Hemophilia: In the second half of 2022, the Company expects to initiate a streamlined clinical program to support registration for SerpinPC for the treatment of Hemophilia B (with and without inhibitors). Additionally, the Company expects to report data from the Phase 2a open label extension study in the fourth quarter of 2022 for the 48-week flat dose portion and the 24-week high dose portion (1.2mg/kg every two weeks). This is anticipated to provide two years of safety and efficacy data across multiple dose levels.
•CBS004 in Autoimmune Diseases: IND is planned for late 2022.

First Quarter 2022 Financial Results
•Cash and Cash Equivalents: $544.5 million as of March 31, 2022 which the Company expects will fund operations to mid-2024, without drawing on the remaining available tranches under the Oberland credit facility.

•Research & Development Expenses: $36.9 million for the quarter ended March 31, 2022 compared to $10.1 million for the period from January 30, 2021 through March 31, 2021.
•General & Administrative Expenses: $14.4 million for the quarter ended March 31, 2022 compared to $5.6 million the period from January 30, 2021 through March 31, 2021.
•Net Loss Attributable to Ordinary Shareholders: $54.5 million for the quarter ended March 31, 2022 compared to $238.7 million for the period from January 30, 2021 through March 31, 2021 (which includes a special non-cash $220.5 million charge for acquired in-process R&D associated with the Centessa subsidiary acquisitions).