On May 5, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it has received allowance from the Polish Department of Registration of Medicinal Products (URPL), as well as the requisite Ethics Committee approval, to proceed with its Phase 1/2 clinical trial in Poland of Annamycin (L-ANN) in combination with Cytarabine (Ara-C) in the treatment of subjects with acute myeloid leukemia (AML) who are refractory to or relapsed after induction therapy (Press release, Moleculin, MAY 5, 2022, View Source [SID1234613685]).

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The Phase 1/2 L-ANN /ARA-C combination (AnnAraC) trial (MB-106), an open label trial, builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials (MB-104 and MB-105) in the U.S. and Europe and the preclinical data discussed below. The study is expected to commence patient enrollment in the first half of 2022.

Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, "We are pleased with the positive feedback from the URPL and are excited to take another step toward initiating this important trial. Bolstered by the encouraging data seen to-date, we believe the combination of Annamycin with Cytarabine has the ability to synergistically improve activity against AML. With this allowance to proceed now in hand, our team is working to get this trial up and running as quickly and efficiently as possible. Based on the continued support received from local physicians in Poland for this AnnAraC trial, we believe we will be able to remain on track to get the trial underway this quarter and build momentum with patient recruitment. We are also working to potentially expand this trial to additional countries in Europe to help further accelerate the rate of recruitment."

Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple human clinical trials, including ongoing trials for the treatment of relapsed or refractory AML and soft tissue sarcoma (STS) lung metastases. Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Furthermore, based on additional preclinical animal data from sponsored research, Annamycin in combination with Cytarabine demonstrated a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone. These data were recently presented at the 62nd Annual Meeting & Exposition of the American Society for Hematology ("ASH") under the title: "High Efficacy of Liposomal Annamycin (L-ANN or Annamycin) in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model."1

In January 2022, the Company reported that it had received an updated independent safety review of certain preliminary data for the first 30 patients in its three Phase 1 clinical trials with Annamycin targeting AML (MB-104 and MB-105) and the metastases of soft tissue sarcoma to the lungs (STS Lung) or MB-107, which concluded there was no evidence of cardiotoxicity. Based on the preliminary data seen in the fifth and final dose escalation cohort of the MB-105 trial, the Company reported Annamycin demonstrated an overall response rate (ORR) of 60%. This included two partial responses (PRs) and one complete response with incomplete recovery of neutrophils and/or platelets (CRi). Upon safely reaching the RP2D of 240 mg/m2 in the MB-105 trial, the Company concluded recruitment for the trial.

About Annamycin

Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple human clinical trials, including ongoing trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, and the Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently prescribed anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes it may have the potential to treat a number of additional indications.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of STS lung metastases, in addition to Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia. For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.

On May 5, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the Company’s management will be speaking at five investor and scientific conferences in May 2022 (Press release, Lantern Pharma, MAY 5, 2022, View Source [SID1234613701]).

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Dr. Kishor Bhatia, Lantern’s Chief Scientific Officer, will be speaking at the 9th Drug Discovery Strategic Summit on May 9th, and presenting on the synthetic lethality potential of Lantern’s drug candidates. Additionally, Panna Sharma, Lantern’s Chief Executive Officer and President, will be speaking at four events in May, including the Strategic Investment Conference on May 13th, the MedVentures Conference on May 18th, the Augmented Intelligence in Drug Discovery Xchange East Coast on May 19th, and the Bioinformatics Strategy Meeting East Coast USA on May 23rd.

Further information on these conferences and events, including registration links, can be found below:

9th Drug Discovery Strategic Summit
Presentation Information: May 9th, 2022 / 4:40 p.m. ET / Boston, MA
Presenter: Kishor Bhatia, Ph.D.
Registration Link: View Source

Strategic Investment Conference 2022
Presentation Information: May 13th, 2022 / 2:45 p.m. ET / Virtual
Presenter: Panna Sharma
Registration Link: View Source

MedVentures Conference
Presentation Information: May 18th, 2022 / 9:30-10:30 a.m. CT / Dallas, TX
Presenter: Panna Sharma
Registration Link: View Source

Augmented Intelligence in Drug Discovery Xchange East Coast
Presentation Information: May 19th, 2022 / 9:05 a.m. ET / Woburn, MA
Presenter: Panna Sharma
Registration Link: https://www.hub-xchange.com/augmented-intelligence-in-drug-delivery-xchange-east-coast-2022/#anchor1

Bioinformatics Strategy Meeting East Coast USA 2022
Presentation Information: May 23rd, 2022 / 3:50 & 4:50 p.m. ET / Cambridge, MA
Presenter: Panna Sharma
Registration Link: https://proventainternational.com/events/rd/usa-east/boston/bioinformatics-strategy-meeting-east-coast-usa-2022/

On May 5, 2022 NantHealth, Inc. (NASDAQ-GS: NH), a leading provider of enterprise solutions that help businesses transform complex data into actionable insights, reported financial results for its first quarter ended March 31, 2022 (Press release, NantHealth, MAY 5, 2022, View Source [SID1234613716]).

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"We are pleased to start the year with positive momentum, with our 2022 first quarter revenue increasing over the previous quarter," said Ron Louks, Chief Operating Officer, NantHealth.

"To help drive further growth, we continue to invest in the development of our products and services, including the expansion of our cloud and data analytics capabilities. These investments are delivering results in multiple ways, including the launch of several new applications on our new cloud platform. Eviti Connect expansion continued with Autoimmune Diseases and our NantHealth Partner Portal which added on-demand customer access to interactive reporting. We are also seeing continued interest in our data enrichment services, as well as pilot programs for The OpenNMS Group Inc.’s cloud services."

Software and Services Q1 Highlights:

Clinical Decision Support (Eviti):
Signed a multi-year renewal with a leading nonprofit, multi-state health plan serving government sponsored programs. The agreement significantly expands the scope of Eviti Connect for Oncology services provided to the plan, including the addition of full delegation services and evidence-based radiation oncology care
Expanded full delegation capabilities to include radiation oncology services in addition to medical oncology, enabling customers to assign prior authorization decisions to NantHealth
New functionality that allows health plan customers to approve and assign a prior authorization Eviti code to portions of a treatment plan, eliminating the need for complete plan resubmission and speeding up treatment to patients
Payer Engagement (NaviNet):
Received HITRUST certification, a highly stringent benchmark that ensures NantHealth continues to meet key regulations and industry-defined security requirements. This places NantHealth and NaviNet Open in an elite group of organizations worldwide that have earned this status for information security
In May 2022, won the MedTech Breakthrough "Healthcare Insurance Innovation Award," recognized for the platform’s innovative ability to break through digital health and technology markets
Enhanced NaviNet Open Authorizations with new processes for automating the collection of additional procedure code modifiers and reducing the need for manual follow-up by the health plan
Network Monitoring and Management (The OpenNMS Group, Inc.):
Released OpenNMS Meridian 2022, the optimized and hardened version of the OpenNMS platform available to annual maintenance subscribers for use in production environments. Meridian 2022 features enhanced security, improved analytics for NetFlow processing, simplified Minion communication and enhanced geolocation with IP addresses
Signed several new professional services agreements with customers using the Horizon and Meridian versions of the OpenNMS platform. This work in collaboration with customers helps to improve the extensibility, reliability, and scalability of the platform for the entire user community
Completed global delivery of 1U hardware appliances, expanding the existing hardware appliance beta program with a large consumer electronics retailer
First Quarter Financial Results: 2022 vs 2021

For the 2022 first quarter:

Total net revenue was $16.4 million compared with $16.2 million.
Gross profit was $9.2 million, or 56% of total net revenue, compared with $9.1 million, or 56% of total net revenue.
Selling, general and administrative (SG&A) expenses increased to $15.0 million from $12.5 million.
Research and development (R&D) expenses increased to $5.7 million from $5.0 million.
Net loss from continuing operations, net of tax, was $16.0 million, or $0.14 per share, compared with $15.4 million, or $0.14 per share.
On a non-GAAP basis, net loss from continuing operations was $12.2 million, or $0.11 per share, compared with $9.6 million, or $0.09 per share.
At March 31, 2022, cash and cash equivalents totaled $16.1 million.
Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the first quarter ended March 31, 2022. The conference call will be available to interested parties by dialing 800-920-5526 from the U.S. or Canada, or 212-231-2907 from international locations. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

On May 5, 2022 Arcadia Biosciences, Inc. (Nasdaq: RKDA), a producer and marketer of innovative, plant-based health and wellness products, reported that it will release its financial and business results for the first quarter of 2022 after market close on May 12, 2022 (Press release, Arcadia Biosciences, MAY 5, 2022, View Source [SID1234613733]).

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The company has scheduled a conference call for 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss first-quarter results and key strategic achievements. Interested participants can join the conference call using the following numbers:

A live webcast of the conference call will be available on the Investors section of Arcadia’s website at www.arcadiabio.com. Following completion of the call, a recorded replay will be available on the company’s investor website.

On MAY 5, 2022 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the quarter ended March 31, 2022 and provided a business update (Press release, INmune Bio, MAY 5, 2022, View Source [SID1234613788]).

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Q1 2022 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro and INB03):

Dosed the first patient in the Phase II trial using XPro to treat patients with mild Alzheimer’s Disease (AD). The primary endpoint will examine cognition using the Early AD/MCI Alzheimer’s Cognitive Composite (EMACC). Data is anticipated in the second half of 2023.
Delivered multiple oral and poster presentations at AD/PD 2022 (International Conference on Alzheimer’s and Parkinson’s Disease).
Presented breast cancer data at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which suggested the use of INmune Bio’s DN-TNF candidate, INB03, may help reverse resistance to immunotherapy patients with HER2+ cancers.
INKmune Platform Highlights:

Planned expansion of INKmune program to include AML and new site in EU.
2 of 3 patients with MDS/AML remain stable more than 6 months after the last treatment with INKmune.
INKmune shows best-in-class therapeutic persistence measured by activated tumor killing NK cells (NKG2D+ NK cells) in the peripheral blood or bone marrow more than 100 days after INKmune treatment in the two patients with stable disease
Highlighted the potential of INKmune primed NK cells to treat solid tumors by improving the ability of natural killer (NK) cells to survive hostile tumor microenvironments and by increased avidity, a necessary step for cancer cell killing, compared to NK cells primed with cytokines (IL-2, IL15).
Upcoming Milestones:

Initiate Xpro Phase 2 program for Mild Cognitive Impairment (MCI) in patients 1H 2022.
Initiate XPro Phase 2 program for treatment resistant depression (TRD), funded in part by a $2.9 million NIH grant, by 2H 2022.
Continued enrollment and opening of sites for XPro Phase 2 program for mild AD.
Initiate INKmune Phase 1 program in ovarian cancer or solid tumor in 2H 2022.
Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML.
Report top-line data from Phase 2 trial of Xpro in MCI patients in mid-2023.
Report top-line data from Phase 2 trial of XPro in Mild AD patients in 2H 2023.
Report pre-clinical INKmune data in renal cell carcinoma and nasopharyngeal carcinoma.
"Our scientific platforms continue to showcase our unique approach to repairing dysfunction of the innate immune system," stated RJ Tesi, M.D., CEO of INmune Bio. "In April, we announced the dosing of our first patient treated with XPro1595 ("XPro) in the treatment of neuroinflammation as a cause of mild Alzheimer’s disease (AD) in a Phase II clinical trial AD02, a blinded, randomized, placebo-controlled multicenter study in Australia, in Canada and in the United States that will assess the cognitive and functional impact of XPro in 201 mild AD patients. A second blinded, randomized, placebo-controlled Phase 2 trial in patients with mild cognitive impairment (MCI) is also planned. It appears that targeting amyloid and tau have little therapeutic benefit. Newer treatment strategies such as targeting glial dysfunction with XPro is supported by pre-clinical and epidemiologic studies. We expect top-line results from both clinical trials in 2023."

"The impact of inflammation and in particular TNF is increasingly apparent as evinced by recent genetic (link) studies," stated CJ Barnum, VP of CNS Development at INmune Bio. "These Phase 2 studies are the first step in determining the extent to which neutralizing solTNF will benefit MCI and AD patients. Our expectations are high, and we look forward to sharing the results next year.

"The clinical and scientific framework around INKmune, our NK cell targeting platform continues to grow. We have already observed that two of the three patients treated with INKmune for MDS/AML remain off therapy with their disease controlled for more than 6 months since their last dose of INKmune," said Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio. "We are demonstrating the effectiveness of INKmune in treatment of hematologic malignancies but believe the most promising application will be using INKmune to treat residual disease in solid tumors."

"Separately, we presented additional pre-clinical breast cancer data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, which further demonstrated the use of our DN-TNF oncology drug candidate, INB03, to potentially help reverse resistance to immunotherapy for women with HER2+ breast cancer. With this robust collection of data in multiple indications, we are optimistic for the coming quarters and look forward to sharing our continued results with shareholders and clinicians alike," stated Dr. Tesi.

"We continue to move forward on our planned three Phase II programs this year and believe we are well positioned to deliver on potential value creating milestones in both our DN-TNF and INKmune platforms," concluded Dr. Tesi.

Financial Results for the Quarter Ended March 31, 2022:

Net loss attributable to common stockholders for the quarter ended March 31, 2022 was approximately $6.9 million, compared to approximately $4.6 million for the quarter ended March 31, 2021.

Revenues totaled approximately $0.2 million for the first quarter 2022 compared to approximately $0.0 million for the first quarter 2021.

Research and development expense totaled approximately $4.3 million for the first quarter 2022 compared to approximately $2.5 million during the first quarter 2021.

General and administrative expense was approximately $2.3 million for the first quarter 2022 compared to approximately $2.1 million during the first quarter 2021.

Other expense was approximately $0.4 million for the first quarter 2022 compared to approximately $0.0 million during the first quarter 2021.

As of March 31, 2022, the Company had cash and cash equivalents of approximately $66.7 million.

During the quarter, RJ Tesi, Mark Lowdell, David Moss and Kelly Ganjei bought 82,900 shares for approximately $700,000 as previously reported in an 8-K filed with the SEC. As of May 5, 2022, the Company had approximately 17.9 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Date: May 5, 2022
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13728543

A live audio webcast of the call can be accessed using this link: View Source

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 12, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13728543.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

About INKmune

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.