On May 6, 2021 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 first quarter ended March 31, 2021 and provided a business update (Press release, INmune Bio, MAY 6, 2021, View Source [SID1234579352]).

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"We continued to treat patients in the Phase I XPro1595 Alzheimer’s disease trial and expand the extensive biomarker data," stated RJ Tesi, M.D., chief executive officer of INmune Bio. "The interim data that we reported in January confirms that XPro1595 decreases neuroinflammation in patients with Alzheimer’s disease and supports transitioning to a blinded randomized placebo-controlled Phase II trial later this year. We regard these results as extremely promising and look forward to further confirmation of XPro1595’s potential benefit to these patients in a rigorously designed Phase 2 study. We will report the additional biomarker data later this Summer."

"We have started screening patients in the Phase I INKmune NK cell priming platform trial in patients with high-risk myelodysplastic syndrome (MDS). MDS is a serious hematopoietic stem cell disorder in which patients have functionally defective NK cells, and approximately one-third of cases progress to AML. We created a short 5-minute video that we believe does a wonderful job explaining why NK cells fail to clear cancer and how the cellular and molecular interactions by INKmune activate NK cells to kill resistant tumors. The video can be found by clicking here."

"Finally, in our Phase 2 trial of Quellor in hospitalized COVID-19 patients with pulmonary complications, we continue to enroll patients. We expect to receive a ‘go/no-go’ decision by the independent Data Safety Monitoring Board following the analysis of the first 100 patients. We believe Quellor will neutralize soluble TNF, the ‘master cytokine’ of the cytokine storm to decrease progressive respiratory symptoms in these hospitalized patients."

"In summary, notwithstanding the ongoing pandemic that continues to disrupt drug development timelines around the world, we believe that we are well positioned to make meaningful advancements across all of our key programs this year," Dr. Tesi concluded.

Q1 2021 and Recent Corporate Highlights

DN-TNF Platform Highlights:

Announced interim Phase 1b data demonstrating that XPro1595 decreased neuroinflammation measured by CSF cytokines correlated with decreases in white matter free water, a validated non-invasive biomarker of neuroinflammation. The data showed the benefits of decreased neuroinflammation with decreased neurodegeneration and improved synaptic function as measured by CSF proteomics and remodeling and repair in the brain due to improvements in white and gray matter quality as measured by MRI.
Data strongly support initiation of a blinded, randomized, placebo-controlled Phase 2 study in 2021 to explore the clinical impact of long-term control of neuroinflammation with XPro1595 in patients with Alzheimer’s disease.
Presented detailed biomarker data during a Key Opinion Leader webinar on January 21, 2021, a replay of which can be accessed here.
Continued to advance its Phase 2 trial of Quellor in hospitalized COVID-19 patients suffering from pulmonary complications toward a "go/no-go" decision by the DSMB around mid-year.
Financial Highlights:

During the first quarter, the Company raised approximately $29 million from the sale of its common shares through a pre-existing open sale market agreement (At-the-Market, or ATM).
Upcoming Milestones:

Report on the first 100 patients enrolled in the company’s Quellor trial in COVID-19 which will provide proof-of-concept and inform a "go/no go" decision by the Data Safety Monitoring Board (DSMB).
Initiate XPro1595 Phase 2 program for treatment resistant depression, funded in part by a $2.9 million NIH grant in the second half of 2021.
Initiate XPro1595 Phase 2 program for Alzheimer’s disease in patients with neuro-inflammation in the second half of 2021.
Initiation of INKmune high-risk MDS trial.
The company plans additional clinical trials after the COVID-19 pandemic has been controlled. The exact timing of these trials cannot be predicted at this time. These trials include:
INKmune Phase 1 program for ovarian cancer.
LIVNate Phase 2 program for NASH.
INB03 Phase 2 program for MUC4 expressing cancer.
Financial Results for the First Quarter Ended March 31, 2021:

Net loss attributable to common stockholders for the quarter ended March 31, 2021 was approximately $4.6 million, compared to approximately $2.1 million for the quarter ended March 31, 2020.

Research and development expense totaled approximately $2.5 million for the quarter ended March 31, 2021, compared to approximately $0.8 million during the quarter ended March 31, 2020.

General and administrative expense was approximately $2.1 million for the quarter ended March 31, 2021, compared to approximately $1.3 million during the quarter ended March 31, 2020.

As of March 31, 2021, the Company had cash and cash equivalents of approximately $45.3 million and no debt.

As of May 5, 2021, the Company had approximately 14.9 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: Wednesday, May 5, 2021
Time: 4:30 PM Eastern Time
Participant Dial-in: 877-407-0784
Participant Dial-in (international): 201-689-8560

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 12, 2021 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13718747.

About XPro1595

XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro1595 could have 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.

On May 6, 2021, ORIC Pharmaceuticals, Inc. (the "Company") reported that it entered into an Open Market Sale AgreementSM (the "Sales Agreement") with Jefferies LLC as the Company’s sales agent (the "Agent"), pursuant to which the Company may offer and sell from time to time through the Agent up to $150 million of shares (the "Shares") of the Company’s common stock, par value $0.0001 per share ("Common Stock"), in such share amounts as the Company may specify by notice to the Agent, in accordance with the terms and conditions set forth in the Sales Agreement (Filing, 8-K, ORIC Pharmaceuticals, MAY 6, 2021, View Source [SID1234579369]).

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Sales, if any, of the Shares pursuant to the Sales Agreement may be made in negotiated transactions or transactions that are deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on The Nasdaq Stock Market. Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The Company is not obligated to sell any Shares under the Sales Agreement.

The Shares will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 ASR which was automatically effective upon filing with the Securities and Exchange Commission (the "Commission") on May 6, 2021. The Company filed a prospectus supplement, dated May 6, 2021, with the Commission in connection with the offer and sale of the Shares. The Company may terminate the Sales Agreement upon written notice to the Agent for any reason or by the Agent upon written notice to us for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company.

The Sales Agreement contains customary representations, warranties and agreements by us, and indemnification rights and obligations of the parties. The Sales Agreement provides that the Agent will be entitled to compensation for its services at a commission rate of up to 3.0% of the gross sales price per share of all shares sold through the Agent under the Sales Agreement. Under the terms of Sales Agreement, the Company agreed to indemnify the Agent against certain specified types of liabilities, including liabilities under the Securities Act, to contribute to payments the Agent may be required to make in respect of these liabilities, and to reimburse the Agent for certain expenses. In the ordinary course of business, the Agent or its respective affiliates from time to time have provided and may in the future provide various investment banking, commercial banking and financial advisory services to the company and/or its affiliates, for which it has received or may receive customary compensation.

The Company intends to use the net proceeds from the sale, if any, of the securities offered in the offering, together with the Company’s existing cash, cash equivalents and short-term investments, to fund the development of ORIC-101, to fund the development of ORIC-533, to fund the development of ORIC-944, to fund the development of ORIC-114, to fund other research and development activities, including the potential acquisition of and drug development activities related to new programs, as well as for working capital and other general corporate purposes. The Company does not have agreements or commitments for any specific acquisitions or strategic transactions at this time.

The above summary of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the Sales Agreement, a copy which is attached as Exhibit 1.1 to this Current Report on Form 8-K and incorporated herein by reference. The legal opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation relating to the shares of Common Stock being offered pursuant to the Sales Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On May 6, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that that it plans to host a conference call on Thursday, May 13, 2021, at 8:30 a.m. ET to discuss its financial results for the quarter ended March 31, 2021 and provide a business update (Press release, Selecta Biosciences, MAY 6, 2021, https://selectabio.gcs-web.com/news-releases/news-release-details/selecta-biosciences-host-conference-call-and-webcast-discuss-4 [SID1234579385]).

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Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10147801. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

On May 6, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported financial results for the first quarter ended March 31, 2021 and provided business updates (Press release, ADC Therapeutics, MAY 6, 2021, View Source [SID1234579403]).

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"We are off to an exciting start to the year with the recent accelerated FDA approval of ZYNLONTA, bringing a new and differentiated treatment option to patients with relapsed or refractory diffuse large B-cell lymphoma," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "ZYNLONTA is approved for a broad population of r/r DLBCL patients, including DLBCL NOS, DLBCL arising from low grade lymphoma and also high-grade B-cell lymphoma. This reflects the real world population of patients enrolled in our LOTIS-2 pivotal trial including transplant eligible and ineligible patients, heavily pre-treated patients and patients with difficult-to-treat disease. In addition, we continue to advance our pipeline of next-generation ADCs for patients with difficult-to-treat hematologic and solid tumor cancers."

"On the occasion of the commercial launch of ZYNLONTA, it has been impressive to see the high quality of talented and experienced commercial and medical affairs professionals at ADC Therapeutics fully prepared for an early FDA approval," said Ron Squarer, Chairman of the Board and an advisor to the Company. "This team is executing on its launch plan and is well equipped to support the treating community in adopting an important new option with a broad label which included tough to treat patients in third-line plus DLBCL."

Recent Highlights

ZYNLONTA (loncastuximab tesirine-lpyl)

FDA accelerated approval and launch: ZYNLONTA was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on April 23, 2021, as a single-agent for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma, a key point of differentiation on the label. ZYNLONTA became commercially available last week and the commercial launch is fully underway.
Added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: As of May 5, 2021, ZYNLONTA was added to the NCCN guidelines with a category 2A recommendation for third-line plus DLBCL, including DLBCL arising from low-grade lymphoma such as follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Ongoing trials progressing:
The Phase 3 LOTIS-5 clinical trial is evaluating ZYNLONTA in combination with rituximab in second-line patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant. This trial will fulfill the post-marketing approval requirement with the FDA for a confirmatory study.
The pivotal Phase 2 LOTIS-3 clinical trial of ZYNLONTA in combination with ibrutinib for relapsed or refractory DLBCL patients is intended to support the submission of a supplemental Biologics License Application (BLA) for ZYNLONTA in combination with ibrutinib.
Additional planned trials in 2021 to potentially expand the ZYNLONTA opportunity:
Pivotal Phase 2 clinical trial in follicular lymphoma (FL).
Clinical trial to evaluate ZYNLONTA in combination with multiple other drugs in B-cell non-Hodgkin lymphoma (NHL).
Dose-finding study of ZYNLONTA in combination with R-CHOP in frontline DLBCL.
Camidanlumab Tesirine (Cami)

Ongoing trials progressing:
The pivotal Phase 2 clinical trial evaluating the efficacy and safety of Cami in patients with relapsed or refractory Hodgkin lymphoma (HL) has completed enrollment and is continuing to follow patients. The Company will present data from this study at an upcoming congress.
The Phase 1b clinical trial of Cami in combination with pembrolizumab in selected advanced solid tumors is an open-label, dose-escalation and dose-expansion trial evaluating the safety, tolerability, pharmacokinetics and antitumor activity of Cami in combination with pembrolizumab, a checkpoint inhibitor.
2021 Expected Milestones

ZYNLONTA

Initiate a pivotal Phase 2 clinical trial of ZYNLONTA in FL in the second quarter of 2021.
Report updated data from the Phase 1 clinical trial of ZYNLONTA in combination with ibrutinib in relapsed or refractory DLBCL in the second quarter of 2021.
Initiate the dose-finding study of ZYNLONTA in first-line DLBCL with R-CHOP in the second half of 2021.
Initiate the clinical trial to evaluate ZYNLONTA in multiple combinations in B-cell non-Hodgkin lymphoma in the second half of 2021.
Complete enrollment in the pivotal Phase 2 trial of ZYNLONTA in combination with ibrutinib in the second half of 2021.
Complete safety lead-in of the Phase 3 LOTIS-5 confirmatory study of ZYNLONTA in combination with rituximab in the second half of 2021.
Cami

Report interim results from the pivotal Phase 2 clinical trial of Cami in HL in the second quarter of 2021.
Earlier-Stage Pipeline

File Investigational New Drug (IND) application for ADCT-901, targeting KAAG1 in the second quarter of 2021.
Initiate a Phase 1b combination study of ADCT-601, targeting AXL, in multiple solid tumors in the first half of 2022.
First Quarter 2021 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $383.1 million as of March 31, 2021, compared to $439.2 million as of December 31, 2020. In the coming days, the Company will be drawing down $50 million associated with its Convertible Credit Facility with Deerfield, which was contingent upon ZYNLONTA approval.

Research and Development (R&D) Expenses

R&D expenses were $39.2 million for the quarter ended March 31, 2021, compared to $35.4 million for the same quarter in 2020. R&D expenses increased due to investments to explore the potential of ZYNLONTA in earlier lines of treatment and histologies and advance the portfolio. As a result of these initiatives, employee headcount and share-based compensation expense increased.

Selling and Marketing (S&M) Expenses

During the first quarter of 2021, S&M expenses were $13.9 million as compared to $2.6 million for the same quarter in 2020. The increase in S&M expenses related to the build-out of the Company’s commercial organization and preparation activities for the anticipated launch of ZYNLONTA in 2021. Prior to December 31, 2020, S&M expenses were reported within General and Administrative ("G&A") expenses within the condensed consolidated interim statement of operations. The period ended March 31, 2020 has been recast to conform to the current year presentation.

G&A Expenses

G&A expenses were $17.6 million for the quarter ended March 31, 2021, compared to $5.9 million for the same quarter in 2020. G&A expenses increased due to higher headcount to support the commercial launch, increased share‐based compensation expense and higher costs of being a public company.

Net Loss and Adjusted Net Loss

Net loss was $51.5 million, or a net loss of $0.67 per basic and diluted share, for the quarter ended March 31, 2021, compared to $43.5 million, or a net loss of $0.85 per basic and diluted share, for the same quarter in 2020. The net loss for the quarter ended March 31, 2021 includes a $21.2 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield. The decrease in fair value was driven by the decrease in the Company’s share price from December 31, 2020. In addition, net loss included share-based compensation expense of $14.0 million for the quarter ended March 31, 2021, compared to $3.8 million for the same quarter in 2020.

Adjusted net loss was $56.8 million, or an adjusted net loss of $0.74 per basic and diluted share, for the quarter ended March 31, 2021, compared to $39.7 million, or an adjusted net loss of $0.78 per basic and diluted share, for the same quarter in 2020. The increase in adjusted net loss was primarily driven by the expansion of the organization, investment in the expanding clinical portfolio and the preparation for the anticipated launch of ZYNLONTA.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2021 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the live call, please dial 888-771-4371 (domestic) or +1 847-585-4405 (international) and provide confirmation number 50158735. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

On May 6, 2021 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported its primary recruitment objective with the recruitment of 440 patients in the global phase III AGENT study (Press release, Isofol Medical, MAY 6, 2021, View Source [SID1234579419]). Today the company announces that it has completed the recruitment of Japanese patients in accordance with the regulatory requirements by the PMDA (the Japanese Medicines Agency) to reach market approval in Japan. As previously communicated, Isofol expects the top line results for the AGENT study to be available during H1 2022.

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Following today’s announcement of the completion of recruitment of Japanese patients, the full patient population, including the entire Japanese cohort, will be included in PMDA’s assessment for a potential market approval in Japan. For a market approval in Japan, the PMDA set a specific requirement for the number of participating Japanese patients of a total of 56 Japanese patients (of which 14 Japanese patients were already included in the primary recruitment of 440 patients) in the AGENT study. The rationale for the specific requirement from PMDA is e.g. that the metabolism of Japanese patients tends to differ from patients in other countries, which is why the effect and potential side effects must be investigated separately.

For the rest of the world, the original 440 patients will be analyzed for efficacy, but the full patient population will be analyzed for safety purposes.

"I am satisfied that we now have completed the recruitment of the Japanese patients, an important step on the way to receive market approval in Japan, the second largest oncology market worldwide. We are now looking forward to continue working with Solasia on the development and registration of arfolitixorin to bring a new treatment option to patients living with mCRC in Japan", said Ulf Jungnelius, M.D, CEO of Isofol.

Solasia Pharma ("Solasia") will fund and supervise clinical development activities in Japan and will be responsible for registrational filing, and following potential regulatory approvals, Solasia will, as the Market Authorization holder, be responsible for the commercialization of arfolitixorin in Japan. Isofol remain the global sponsor of the AGENT study.

"We are very pleased to have completed the recruitment of the target number of patients in Japan in the AGENT study and contributed to the global development of arfolitixorin. I would like to thank all the patients and investigators participating in the study, the CRO in charge of conducting the study, and Isofol, our partner and the sponsor of the AGENT study, for supporting us achieve this important goal. Patient recruitment was completed earlier than expected, and Solasia, together with Isofol, will further proceed development of arfolitixorin for market approval in Japan with the aim of becoming a new treatment option for mCRC patients", said Yoshihiro Arai, President & CEO of Solasia.

Arfolitixorin is evaluated in the AGENT study for the treatment of patients with first-line metastatic colorectal cancer (mCRC). The study is currently being conducted in the U.S., Canada, Europe, Australia and Japan in more than 90 clinics.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on May 6, 2021.

About the AGENT study

The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5- FU, oxaliplatin, and bevacizumab, in first-line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin. The study is ongoing at approximately 90 sites in the U.S., Canada, Europe, Australia and Japan. In December 2020, the last of the AGENT study’s 440 patients was recruited, which is the basis in the statistical analysis plan. Recruitment has since continued in Japan to reach 56 Japanese patients. Isofol is now focusing on completing the ongoing AGENT study where the patients receive first-line standard treatment for metastatic colorectal cancer (mCRC). The company expects that the results of the AGENT study will be available during H1 2022.Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id: NCT03750786.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.