A Phase 4, Open Label Field Study to Evaluate the Clinical Benefit, Safety, and Pharmacokinetics of Anthim (Obiltoxaximab) When Used in the Treatment of Suspected, Probable, or Confirmed Cases of Inhalational Anthrax Due to B. Anthracis

This field study is a post-marketing requirement from the FDA to evaluate the clinical benefit (course of illness and survival), safety and pharmacokinetics of obiltoxaximab administered to patients as part of their medical care for treatment or prophylaxis of inhalational anthrax infection following exposure to Bacillus anthracis (B. anthracis). The protocol can be implemented for any individual who receives obiltoxaximab for a suspected, probable, or confirmed case of inhalational anthrax due to B. anthracis in the United States, including sporadic cases, small incidents and/or a mass event. In case of a small anthrax incident, to the extent possible, the information will be collected prospectively at prespecified time points, except where it would interfere with management of the subject's illness. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study are anticipated to be collected retrospectively. Both retrospective and prospective data collection are allowed to maximize information collection. This study will collect data on the use of obiltoxaximab in anthrax infected or exposed subjects and the data collected will inform the understanding of the clinical benefit and safety of obiltoxaximab.

Start Date01 Dec 2023

Sponsor / Collaborator

Elusys Therapeutics, Inc.

[+2]

NCT01952444 / CompletedPhase 1

An Open-Label, Randomized, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of ETI-204 Alone and in the Presence of Ciprofloxacin in Adult Volunteers

Evaluate the safety, tolerability and pharmacokinetics (PK) of intravenous (IV) ETI-204 alone and in the presence of IV and oral ciprofloxacin

Start Date29 Oct 2013

Sponsor / Collaborator

Elusys Therapeutics, Inc.

NCT01932437 / CompletedPhase 1

A Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular Doses of ETI-204 in Adult Volunteers

This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers

Start Date26 Jul 2013

Sponsor / Collaborator

Elusys Therapeutics, Inc.

100 Clinical Results associated with Obiltoxaximab

100 Translational Medicine associated with Obiltoxaximab

100 Patents (Medical) associated with Obiltoxaximab

Literatures (Medical) associated with Obiltoxaximab

17 Oct 2022·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Pre- and Postlicensure Animal Efficacy Studies Comparing Anthrax Antitoxins

Article

Author: Boucher, David ; Cook, Rachel ; Slay, Raymond M ; Hendricks, Katherine ; Merchlinsky, Michael

Abstract:

Background:

The deliberate use of Bacillus anthracis spores is believed by the US government to be a high bioweapons threat. The first line of defense following potential exposure to B. anthracis spores would be postexposure prophylaxis with antimicrobials that have activity against B. anthracis. Additional therapies to address the effects of toxins may be needed in systemically ill individuals. Over the last 2 decades, the United States government (USG) collaborated with the private sector to develop, test, and stockpile 3 antitoxins: anthrax immunoglobulin intravenous (AIGIV), raxibacumab, and obiltoxaximab. All 3 products target protective antigen, a protein factor common to the 2 exotoxins released by B. anthracis, and hamper or block the toxins’ effects and prevent or reduce pathogenesis. These antitoxins were approved for licensure by the United States Food and Drug Administration based on animal efficacy studies compared to placebo.

Methods:

We describe USG-sponsored pre- and postlicensure studies that compared efficacy of 3 antitoxins in a New Zealand White rabbit model of inhalation anthrax; survival following a lethal aerosolized dose of B. anthracis spores was the key measure of effectiveness. To model therapeutic intervention, intravenous treatments were started following onset of antigenemia.

Results:

In pre- and postlicensure studies, all 3 antitoxins were superior to placebo; in the postlicensure study, raxibacumab and obiltoxaximab were superior to AIGIV, but neither was superior to the other.

Conclusions:

These data illustrate the relative therapeutic benefit of the 3 antitoxins and provide a rationale to prioritize their deployment.

11 Mar 2022·ACS infectious diseasesQ2 · MEDICINE

Exotoxin-Targeted Drug Modalities as Antibiotic Alternatives

Q2 · MEDICINE

Review

Author: Laisi, Arttu ; Sakari, Moona ; Pulliainen, Arto T.

The paradigm of antivirulence therapy dictates that bacterial pathogens are specifically disarmed but not killed by neutralizing their virulence factors. Clearance of the invading pathogen by the immune system is promoted. As compared to antibiotics, the pathogen-selective antivirulence drugs hold promise to minimize collateral damage to the beneficial microbiome. Also, selective pressure for resistance is expected to be lower because bacterial viability is not directly affected. Antivirulence drugs are being developed for stand-alone prophylactic and therapeutic treatments but also for combinatorial use with antibiotics. This Review focuses on drug modalities that target bacterial exotoxins after the secretion or release-upon-lysis. Exotoxins have a significant and sometimes the primary role as the disease-causing virulence factor, and thereby they are attractive targets for drug development. We describe the key pre-clinical and clinical trial data that have led to the approval of currently used exotoxin-targeted drugs, namely the monoclonal antibodies bezlotoxumab (toxin B/TcdB, Clostridioides difficile), raxibacumab (anthrax toxin, Bacillus anthracis), and obiltoxaximab (anthrax toxin, Bacillus anthracis), but also to challenges with some of the promising leads. We also highlight the recent developments in pre-clinical research sector to develop exotoxin-targeted drug modalities, i.e., monoclonal antibodies, antibody fragments, antibody mimetics, receptor analogs, neutralizing scaffolds, dominant-negative mutants, and small molecules. We describe how these exotoxin-targeted drug modalities work with high-resolution structural knowledge and highlight their advantages and disadvantages as antibiotic alternatives.

14 Apr 2021·Infectious disorders drug targets

Monoclonal Antibodies Against Infectious Microbes: So Long and Too Little!

Review

Author: Adhimoolam, Mangaiarkkarasi ; Raj, Gerard M. ; Murugesan, Sakthibalan ; Priyadarshini, Rekha

Monoclonal antibodies (mAbs) as alternatives or more often as complementary to the conventional antimicrobials have been developed for the management of infectious conditions for the past two decades. These pharmacotherapeutic strategies are inevitable as the burden of antimicrobial resistance is far-reaching in recent times. MAbs are part of the targeted pharmacotherapy armamentarium with a high degree of specificity - hence, exert comparatively superior efficacy and tolerability than the conventional polyclonal antisera. So far, only five mAbs have been approved for the management of infectious states, since the marketing authorization (1998) given to palivizumab (Synagis®) for the prophylaxis of lower respiratory tract disease caused by a respiratory syncytial virus in pediatric patients. Ibalizumab-uiyk (Trogarzo™) used for the management of multidrug-resistant HIV-1 infection not yielding to at least 10 antiretroviral drugs, was approved recently. Among the three antibacterial mAbs, raxibacumab (ABthrax®/ Anthrin®) and obiltoxaximab (Anthim®) are indicated for the treatment and prophylaxis of inhalation anthrax due to Bacillus anthracis; bezlotoxumab (Zinplava®) is used to reduce the recurrence of Clostridium difficile infection. There are also around 30 and 15 mAbs in different phases of development for viral and bacterial conditions. As alternatives to the traditional antivirals and antibacterials, the antimicrobial mAbs are the need of the hour. These mAbs are more relevant to the management of conditions like emerging viral outbreaks wherein there is a lack of prophylactic vaccines. The current cutting-edge engineering technologies revolutionizing the production of mAbs include phagedisplayed antibody libraries, cloning from single-memory B cells or single-antibody-secreting plasma B cells, proteomics-directed cloning of mAbs from serum clubbed with high-throughput sequencing techniques. Yet, the cost of manufacture continues to be the main limiting factor. In this review, the different therapeutic monoclonal antibodies directed against the microbial pathogens are discussed.

News (Medical) associated with Obiltoxaximab

20 Nov 2023

·www.globenewswire.com

NightHawk Biosciences Provides Q3 2023 Business Update

DURHAM, N.C., Nov. 20, 2023 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company specializing in the end-to-end development, manufacturing, and commercialization of innovative therapies, today provided strategic, financial, and operational updates for the quarter ended September 30, 2023. Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We are very pleased with the progress of our Scorpius San Antonio facility where operations are advancing well and the feedback from our customers has been extremely positive. As a result, we are currently evaluating a variety of strategic options to maximize the potential of the business. We look forward to providing further updates on our efforts in the near future.” Third Quarter 2023 Financial Results In August, the Company determined to make available for sale the equity interests of Elusys Therapeutics, Inc. Therefore, the results of operations have been reclassified as discontinued operations on a retrospective basis for all periods presented.For the three months ended September 30, 2023 we recognized $6.7 million of revenue from product sales, which is included in discontinued operations, $0.6 million of revenue from process development and $0.1 million from service revenue. For the three months ended September 30, 2022 we recognized $5.98 million of product sales revenue, which is included in discontinued operations, and $0.5 million of grant revenue. The increase in product sales revenue is due to the completion of the manufacturing conversion of ANTHIM® and the increase in process development revenue is attributable to the operations of the San Antonio CDMO facility. No grant revenue was recognized in 2023 as the CPRIT grant has ended.Cost of revenues were $2.7 million for the three months ended September 30, 2023. $2.2 million of these expenses primarily reflect the manufacturing conversion costs from the sale of ANTHIM® which are included in discontinued operations. The remaining $0.5 million primarily consists of direct cost of labor, overhead and material costs at Scorpius. We recognized $6.4 million of product cost of revenues for the three months ended September 30, 2022, driven by the sale of ANTHIM® to Canada which is included in discontinued operations.Research and development expenses decreased approximately 3.7% to $5.2 million for the three months ended September 30, 2023, compared to $5.4 million for the three months ended September 30, 2022. The components of R&D expense are as, in millions: HS-110 expense decreased by $0.1 million primarily due to the discontinuation of the clinical trial in 2022; HS-130 expense decreased to $0.0 from $0.1 million due to the de-prioritization of our oncology assets; PTX-35 expense decreased by $0.5 million primarily due to the discontinued clinical trial and development of the product candidate in the third quarter of 2022; other programs expense stayed consistent at $0.3 million and primarily relate to close out costs of our R&D facility; and unallocated research expenses increased by $0.5 million primarily due to increased personnel costs, depreciation expense, amortization expense and scientific hardware and software.Selling, general and administrative expenses were $6.1 million and $4.8 million for the three months ended September 30, 2023 and 2022, respectively. The increase was primarily due to increases in marketing expense of $0.6 million, personnel expense of $0.4 million, depreciation and amortization of $0.2 million, and rent expense of $0.2 million, offset by a decrease in insurance expense of $0.1 million.As of September 30, 2023, the Company had approximately $9.5 million in cash, cash equivalents, and short-term investments of which $3.3 million is in current assets held for sale. NightHawk Biosciences, Inc.NightHawk Biosciences leverages its integrated ecosystem of subsidiaries to streamline the advancement of novel therapies, breaking through barriers that prolong traditional drug development. This empowers us to bring our ideas to life with efficient control, superior quality, and uncharacteristic agility. For more information on the Company and its subsidiaries, please visit: www.nighthawkbio.com, and also follow us on Twitter. Forward Looking StatementThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as the evaluation of a variety of strategic options to maximize the potential of the Scorpius San Antonio operations and providing updates on the Company’s efforts in the near future. Important factors that could cause actual results to differ materially from current expectations include, among others, , NightHawk’s ability to successfully maximize the potential of its operations, NightHawk’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, NightHawk’s ability to successfully operate as a CDMO, NightHawk’s and its subsidiaries’ ability to maintain license agreements, the continued maintenance and growth of NightHawk’s and its subsidiaries’ patent estates, , the ability to obtain required regulatory approval or to comply with ongoing regulatory requirements, regulatory limitations relating to NightHawk’s ability to promote or commercialize its product candidates for the specific indications, acceptance of product candidates and services in the marketplace and the successful development, marketing or sale of NightHawk’s services and products, developments by competitors that render such products or services obsolete or non-competitive, and other factors described in NightHawk’s annual report on Form 10-K for the year ended December 31, 2022, subsequent quarterly reports on Form 10-Qs and any other filings NightHawk makes with the SEC. The information in this presentation is provided only as of the date presented, and NightHawk undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law. Media and Investor Relations ContactDavid Waldman+1 919 289 4017investorrelations@heatbio.com

Financial Statement

15 May 2023

·www.globenewswire.com

NightHawk Biosciences Provides Q1 2023 Business Update

DURHAM, N.C., May 15, 2023 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company specializing in the end-to-end development, manufacturing, and commercialization of innovative medical countermeasures that combat unmet and emerging biothreats, today provided strategic, financial, and operational updates for the quarter ended March 31, 2023. Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We continue to invest in and advance our research and biomanufacturing efforts, including our San Antonio and Manhattan, Kansas biologics manufacturing facilities. We are making steady progress and look forward to providing further updates.” 2023 Financial Results For the three months ended March 31, 2023 we recognized $0.1 million of revenue from a licensing agreement with Shattuck Labs and $0.7 million of revenue from Scorpius biomanufacturing services. For the three months ended March 31, 2022 we recognized $0.2 million of grant revenue for qualified expenditures under the CPRIT grant. The decrease in grant revenue in the current-year period is due to the fact that we have recognized all $15.2 million of CPRIT grant revenue. As of March 31, 2023, we had a grants receivable balance of $1.5 million for the final CPRIT tranche, and received those funds in April 2023. . We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.Research and development expenses increased approximately 79.5% to $7.0 million for the three months ended March 31, 2023 compared to $3.9 million for the three months ended March 31, 2022. The components of R&D expense are as follows: HS-110 expense decreased $0.1 million primarily due to a decrease in consultants and contract labor expense; HS-130 expense decreased to $0 from $0.5 million due to the deprioritization of the oncology assets; PTX-35 expense increased by $0.3 million primarily due to the expensing of prepaid expenses associated with the discontinued clinical trials and development of the product candidate in the third quarter of 2022;ANTHIM® (obiltoxaximab) was not acquired until the second quarter of 2022 and the 2023 expense primarily relates to fill finish; other programs expense increased by $0.4 million primarily due to increase in laboratory supplies expense related to preclinical R&D expenses and the operations of the CDMO facility; Unallocated research expenses increased by $2.7 million primarily due to increased personnel costs, including stock-based compensation from stock awards, contractor expense and supplies purchased for discovery projects;Cost of revenues were $0.6 million for the three months ended March 31, 2023. These expenses primarily reflect direct cost of labor, overhead and material costs for Scorpius biomanufacturing services. There was no cost of revenues for the three months ended March 31, 2022 as the Scorpius facility was not operational.Selling, general and administrative expenses were $6.8 million and $3.8 million for the three months ended March 31, 2023 and 2022, respectively. The increase was primarily due to an increase of $1.9 million for consulting and other professional expenses to manage the business and increased personnel costs of $1.0 million, and to a lesser extent, an increase in rent expense of $0.3 million, offset by a decrease in stock-based compensation expense of $0.1 million.Net loss attributable to NightHawk Biosciences was approximately $12.8 million, or ($0.49) per basic and diluted share, for the three months ended March 31, 2023, compared to approximately $8.1 million, or ($0.32) per basic and diluted share, for the three months ended March 31, 2022.As of March 31, 2023, the Company had approximately $28.6 million in cash, cash equivalents, and short-term investments. About ANTHIM Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans. ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion. Indications and Usage ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis. IMPORTANT SAFETY INFORMATION Including BOXED WARNING WARNING: HYPERSENSITIVITY and ANAPHYLAXISHypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. WARNINGS AND PRECAUTIONS Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity. ADVERSE REACTIONS The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity. USE IN SPECIFIC POPULATIONS Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population. To see the complete prescribing information for ANTHIM, click here. NightHawk Biosciences, Inc.NightHawk Biosciences is a fully-integrated biopharmaceutical company focused on the discovery and commercialization of innovative medical countermeasures to defend against emerging biothreats. The Company leverages its integrated ecosystem of subsidiaries to streamline the advancement of novel therapies, breaking through barriers that prolong traditional drug development. This empowers us to bring our ideas to life with efficient control, superior quality, and uncharacteristic agility. For more information on the Company and its subsidiaries, please visit: www.nighthawkbio.com, and also follow us on Twitter. Forward Looking StatementThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as continuing to invest in and advance NightHawk’s research and biomanufacturing efforts, including its San Antonio and Manhattan, Kansas biologics manufacturing facilities, and making steady progress and providing further updates. Important factors that could cause actual results to differ materially from current expectations include, among others, NightHawk’s ability to continue to invest in and advance its research and biomanufacturing efforts, including its San Antonio and Manhattan, Kansas biologics manufacturing facilities, NightHawk’s ability to increase sales of ANTHIM® (obiltoxaximab) including distribution abroad, NightHawk’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, NightHawk’s ability to commence operation in Kansas when anticipated and to successfully operate as a CDMO in San Antonio and Kansas, NightHawk’s and its subsidiaries’ ability to maintain license agreements, the continued maintenance and growth of NightHawk’s and its subsidiaries’ patent estates, NightHawk’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, the ability to initiate clinical trials and if initiated, the ability to complete them on time and achieve the desired results and benefits, the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to NightHawk’s ability to promote or commercialize its product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of NightHawk’s products, developments by competitors that render such products obsolete or non-competitive, and other factors described in NightHawk’s annual report on Form 10-K for the year ended December 31, 2022, subsequent quarterly reports on Form 10-Qs and any other filings NightHawk makes with the SEC. The information in this presentation is provided only as of the date presented, and NightHawk undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law. Media and Investor Relations ContactDavid Waldman+1 919 289 4017investorrelations@heatbio.com

Financial StatementLicense out/in

14 Nov 2022

·www.globenewswire.com

NightHawk Biosciences Provides Third Quarter 2022 Business Update

DURHAM, N.C., Nov. 14, 2022 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully-integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today provided strategic, financial, and operational updates for the third quarter ended September 30, 2022. Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We are continuing to progress our biodefense and biomanufacturing efforts within our Elusys and Scorpion subsidiaries. Towards this end, we are making substantial investments in our biomanufacturing capabilities, including our Scorpion San Antonio biologics manufacturing facility, as well as our planned biomanufacturing facility in Manhattan, Kansas.” Mr. Wolf continued, “Given our evolving focus, we are deprioritizing our oncology programs and discontinuing further development of our clinical-stage oncology assets, including HS-110 and PTX-35, to focus on our biomanufacturing efforts and the discovery, development, and commercialization of innovative medical countermeasures to address unmet and emerging biothreats.” Mr. Wolf added, “During the quarter, we also recognized $6 million of one-time revenue, related to the sale of ANTHIM® to Canada’s National Emergency Strategic Stockpile, with 80% of these proceeds to be paid out to the former shareholders of Elusys as part of the original purchase consideration. Nevertheless, we believe this is validation of our strategic decision to acquire Elusys earlier this year.” Third Quarter 2022 Financial Results Recognized $6.0 million of revenue for the quarter ended September 30, 2022, which included $5.98 million of product sales revenue, $0.06 million of contract revenue, and no CPRIT grant revenue. For the three months ended September 30, 2021 we recognized $0.5 million of grant revenue for qualified expenditures under the CPRIT grant. The increase in product sales revenue is due to the sale of ANTHIM to the Canadian government. The decrease in grant revenue in the current-year period is due to the fact that we have recognized all $15.2 million of CPRIT grant revenue. As of September 30, 2022, we had a grants 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.Product cost of sales for the three months ended September 30, 2022 was $6.4 million. No product sales were recognized for the three months ended September 30, 2021. The increase was due to the cost of sales related to the ANTHIM sale to Canada’s National Emergency Strategic Stockpile. Cost of sales was $5.9 million of inventory, $0.3 million of pre-acquisition backlog, $0.2 million of shipping and fulfillment expense and $0.01 million of royalty expense.Research and development expenses increased to $6.9 million for the three months ended September 30, 2022 compared to $4.4 million for the three months ended September 30, 2021.General and administrative expenses were $5.1 million and $3.4 million for the three months ended September 30, 2022 and 2021, respectively. The increase was primarily due to increased personnel costs, as well as higher consulting and professional expenses, offset by a decrease in stock-based compensation expense of $0.2 million.Net loss attributable to NightHawk Biosciences was approximately $13.0 million, or ($0.51) per basic and diluted share for the three months ended September 30, 2022, compared to approximately $7.4 million, or ($0.30) per basic and diluted share for the three months ended September 30, 2021.As of September 30, 2022, the Company had approximately $57.4 million in cash and cash equivalents, and short-term investments. NightHawk Biosciences, Inc.NightHawk Biosciences is a fully-integrated biopharmaceutical company focused on the discovery and commercialization of innovative medical countermeasures to defend against emerging biothreats. The Company leverages its integrated ecosystem of subsidiaries to streamline the advancement of novel therapies, breaking through barriers that prolong traditional drug development. This empowers us to bring our ideas to life with efficient control, superior quality, and uncharacteristic agility. For more information on the Company and is subsidiaries, please visit: www.nighthawkbio.com, and also follow us on Twitter. Forward Looking StatementThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as continuing to make progress in our biodefense and biomanufacturing efforts through our Elusys and Scorpion subsidiaries the planned biomanufacturing facility in Manhattan, Kansas and the sale to Canada’s National Emergency Strategic Stockpile being validation of NightHawk’s strategic decision to acquire Elusys earlier this year. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to continue to make progress in our biodefense and biomanufacturing efforts through our Elusys and Scorpion subsidiaries, the ability to successfully integrate Elusys and expand ANTHIM® distribution abroad, NightHawk’s ability to commence operation in Kansas when anticipated and to successfully operate as a CDMO in San Antonio and Kansas, NightHawk’s and its subsidiaries’ ability to maintain license agreements, the continued maintenance and growth of NightHawk’s and its subsidiaries’ patent estates, NightHawk’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, the ability to initiate clinical trials and if initiated, the ability to complete them on time and achieve the desired results and benefits, the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to NightHawk’s ability to promote or commercialize its product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of NightHawk’s products, developments by competitors that render such products obsolete or non-competitive, and other factors described in NightHawk’s annual report on Form 10-K for the year ended December 31, 2021, subsequent quarterly reports on Form 10-Qs and any other filings NightHawk makes with the SEC. The information in this presentation is provided only as of the date presented, and NightHawk undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law. Media and Investor Relations ContactDavid Waldman+1 919 289 4017investorrelations@heatbio.com

Financial StatementAcquisition

100 Deals associated with Obiltoxaximab

External Link

KEGG	Wiki	ATC	Drug Bank
D10776	Obiltoxaximab	J06BB22	DB05336

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Anthrax	CA	Elusys Therapeutics, Inc.	13 Sep 2022
Inhalation Anthrax	US	Elusys Therapeutics, Inc.	18 Mar 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01932437 (CTgov)	Phase 1	Inhalation Anthrax	36	Placebo+ETI-204 (Cohort 1)	jtqllykssb(kgxxajvsml) = ztojhgodiz hqwbcgglox (dzukvyimwf, zyvyqtrnar - ppnjutegnv) View more	-	01 May 2019
				Placebo+ETI-204 (Cohort 2)	jtqllykssb(kgxxajvsml) = wzsytxywbl hqwbcgglox (dzukvyimwf, xnclahtrmi - itlzwabkgb) View more
NCT01932242 (CTgov)	Phase 1	Inhalation Anthrax	70	Placebo+ETI-204 (Sequence A)	fwfgbodkgl(vbghuritpb) = ioxnyhphwh reaggibool (phahofjjwb, bxwjqiposq - ukavxjiicm) View more	-	22 Apr 2019
				Placebo+ETI-204 (Sequence B)	fwfgbodkgl(vbghuritpb) = vtwayzieyg reaggibool (phahofjjwb, erioejrniz - hocotpcxxs) View more
NCT01952444 (CTgov)	Phase 1	Inhalation Anthrax	40	Ciprofloxacin+ETI-204 (ETI-204 + Ciprofloxacin)	cvhitbxilq(zvjeapzriq) = jbhyhdpwjp lbgcqnhive (qettjgkrjx, xmsazoifmq - bmxoahezqu) View more	-	08 Apr 2019
				diphenhydramine+ETI-204 (ETI-204)	cvhitbxilq(zvjeapzriq) = jtkrfnnyax lbgcqnhive (qettjgkrjx, whxwrdabrl - edqgmrndpj) View more
NCT01929226 (CTgov)	Phase 1	Inhalation Anthrax	280	ETI-204	uauyitzoiy(rhrwevxjhg) = dsotkawgtd jkmykhqlxk (dwlnxxkxmy, jkjsrpuoee - gycqpcacdp) View more	-	08 Apr 2019

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Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis