Puma Biotechnology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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On March 3, 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 year ended December 31, 2021 and provided a business update (Press release, INmune Bio, MAR 3, 2022, View Source [SID1234609522]).

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In December, the Company reported data from the first patient treated with INKmuneTM in the myelodysplastic syndrome (MDS) Phase I clinical trial. More than 100 days after the course of INKmuneTM therapy, 60% of the patient’s NK cells showed the activated, tumor killing memory like NK cells phenotype, a fourfold increase from pre-treatment. The patient’s memory like NK cells killed >70% of NK resistant tumor cells in an in vitro assay. The patient remains well and with an ECOG status of 0, a two-point drop from pre-treatment. Additionally, two patients were treated with INKmuneTM under compassionate use after having failed at least one allogeneic bone marrow transplant. One of the two patients has been discharged home, one remains hospitalized. In all cases, INKmuneTM therapy was well tolerated, safe and was given without any type of pre-medication or cytokine therapy.

"These patients demonstrate the unique attributes of INKmuneTM therapy in patients with high-risk MDS/AML. INKmuneTM converted the patient’s resting NK cells into cancer killing memory like NK cells. The memory like NK cells killed NK-resistant cancer cells in an in vitro assay. Both these attributes lasted four months, a trait we are calling therapeutic persistence." stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We are continuing to screen patients for enrollment into the trial and are in process of expanding the number of clinical trial sites."

The Phase II clinical trial using XProTM to treat patients with AD and elevated biomarkers of neuroinflammation (ADi) is open, screening patients and seeking to enroll the first patient. A second Phase II trial in patients with Mild Cognitive Impairment (MCI) should begin enrolling patients soon. Patients must have ApoE4 to be included in the MCI trial. INMB is treating MCI and Mild AD in separate clinical trials due to differences in disease severity with the potential for different rates of response to therapy. The MCI trial is a three-month trial designed to determine the extent to which XProTM has an impact on biological and cognitive biomarkers in MCI patients. The mild AD trial is a six-month trial with EMACC as the primary endpoint and secondary endpoints of CDR, ADL, NPI, MRI, and blood biomarkers of neurodegeneration. Top line data is expected in the first half of 2023 from the MCI trial and the second half of 2023 from the mild ADi trial. A video released today can be found on the company’s website which explains our rationale for XPro in treating neuroinflammation to potentially reduce white and gray matter degeneration which can be found by clicking here.

Q4 2021 and Recent Corporate Highlights

IINKmuneTM Platform Highlights:

The Phase I program has been peer-reviewed by the UK National Cancer Research Institute (NCRI) – Myelodysplastic Syndrome Expert Group and has been accepted for listing on their national MDS trials site. This is unique to the UK; no equivalent system is present in the US. This allows specialist MDS trials centers to refer patients to the current UK clinical trial sites for treatment under the clinical trial protocol or to request to become an additional trial site. We hope this added validation of the trial and exposure to additional expert centers will provide more patients for enrollment into the Phase I MDS program and facilitate future phase II trials.
Presented 119-day data on first patient in company’s ongoing Phase 1 clinical trial of its Natural Killer (NK) cell priming platform, INKmuneTM, as a potential treatment for high-risk myelodysplastic syndrome (MDS). A single course of INKmuneTM has benefited the course the patient’s disease for more than 6 months. The data were presented at the 2021 British Society of Immunology Congress.
Announced a pre-clinical research collaboration with the Chinese University of Hong Kong to evaluate INKmuneTM, the company’s pseudokine NK cell priming platform, in nasopharyngeal cancer (NPC), a type of head and neck cancer. The project provides INMB scientists working at University College of London with access to the only three proven NPC cancer cell lines to test the ability of INKmuneTM-primed NK cells to kill NPC tumors. This pre-clinical work, if successful, will provide data for a future clinical trial in NPC.
DN-TNF Platform Highlights (XProTM and INB03TM):

Opened the Phase II trial using XProTM to treat patients with mild ADi for enrollment. The primary endpoint will examine cognition using the Early AD/MCI Alzheimer’s Cognitive Composite (EMACC). Multiple secondary endpoints of cognition will also be measured, including CDR-SB, ADAS-COG13 and other endpoints. Data is anticipated in the second half of 2023.
Delivered multiple oral and poster presentations at the AAIC 2022 (Alzheimer’s Association International Conference) and the 14th Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting.
Presented new breast cancer data at the 2021 San Antonio Breast Cancer Symposium. A significant percentage of women with triple negative breast cancer (TNBC) express MUC4. MUC4 expression predicts a worse survival and increased risk of developing metastatic disease. In addition, MUC4 expressing patients have "cold" tumors with fewer tumor infiltrating lymphocytes. These data suggest the use of INmune’s DN-TNF candidate, INB03TM, may help reverse resistance to immunotherapy women with TNBC.
Upcoming Milestones:

Initiate XProTM Phase II program for Mild Cognitive Impairment (MCI) in patients with APOE4 allele 1H 2022.
Initiate XProTM Phase II program for treatment resistant depression (TRD), funded in part by a $2.9 million NIH grant, by 2H 2022.
Initiate INKmune Phase I program in ovarian cancer in 2H 2022.
Additional open-label Phase 1 trial data of INKmuneTM in high-risk MDS.
Report top-line data from Phase 2 trial of XProTM in MCI patients in 1H 2023.
Report top-line data from Phase 2 trial of XProTM in mild Alzheimer’s patients in 2H 2023.
Present INKmuneTM clinical data and new pre-clinical data on mechanism of action at the Innate Killer Summit conference in San Diego in March.
Report pre-clinical INKmuneTM data in at least two new solid tumor indications, renal cell carcinoma and nasopharyngeal carcinoma.
Oral and Poster presentations at AD/PD 2022, the largest European AD meeting. The meeting will be held in Barcelona in March.
Financial Results for the Year Ended December 31, 2021:

Net loss attributable to common stockholders for the year ended December 31, 2021 was approximately $30.3 million, compared to approximately $12.1 million for the year ended December 31, 2020.

Revenues were approximately $0.2 million for the year ended December 31, 2021, compared to $0.0 million for the year ended December 31, 2020.

Research and development expense totaled approximately $20.5 million for the year ended December 31, 2021, compared to approximately $5.9 million during the year ended December 31, 2020.

General and administrative expense was approximately $8.8 million for the year ended December 31, 2021, compared to approximately $6.3 million during the year ended December 31, 2020.

Other expense was approximately $1.2 million during the year ended December 31, 2021 compared to other income of approximately $0.1 million during the year ended December 31, 2020.

As of December 31, 2021, the Company had cash of approximately $74.8 million.

As of March 3, 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.

A live audio webcast of the call can be accessed using this link: View Source;tp_key=636ec61ab2

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through March 10, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13726701.

About XProTM

XProTM 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. XProTM 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.

About INKmuneTM

INKmune is a pharmaceutical-grade, replication-incompetent derivative of our proprietary INB16 cell line, a human tumor cell line, which conjugates to resting NK cells and delivers multiple essential priming signals akin to treatment with a combination of at least three cytokines. INKmuneTM is stable at -80 °C and is delivered by a simple IV infusion. The INKmuneTM: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 tumor lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors, including: leukemias, lymphomas, myeloma, ovarian cancer, and breast cancer.

On March 3, 2022, X4 Pharmaceuticals, Inc. (the "Company"), reported that it entered into a securities purchase agreement (the "Securities Purchase Agreement") with BCLS II Investco, LP (the "Investor"), an affiliate of Bain Capital Life Sciences, pursuant to which the Company agreed to issue and sell to the Investor in a private placement (the "Private Placement") (i) 900,000 shares (the "Shares") of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at a purchase price of $1.80 per share, which represents the volume weighted average price per share of the Common Stock as quoted on the Nasdaq Stock Market for the thirty (30) consecutive-day trading day period ending on March 2, 2022, and (ii) pre-funded warrants (the "Pre-Funded Warrants") to purchase 766,666 shares of Common Stock at a price of $0.01 per share, at a purchase price of $1.79 per Pre-Funded Warrant (Filing, 8-K, X4 Pharmaceuticals, MAR 3, 2022, View Source [SID1234609507]). The price per Pre-Funded Warrant represents the price of $1.80 per share to be sold in the Private Placement, minus the $0.01 per share exercise price of each such Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire.

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The Pre-Funded Warrants to be issued in the Private Placement will provide that the holder of the Pre-Funded Warrants will not have the right to exercise any portion of its Pre-Funded Warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to such exercise (the "Beneficial Ownership Limitation"); provided, however, that the holder may increase or decrease the Beneficial Ownership Limitation by giving 61 days’ notice to the Company, but not to any percentage in excess of 19.99%.

The Private Placement is expected to close on or about March 7, 2022 (the "Closing Date"), subject to the satisfaction of certain customary closing conditions. The Company expects to receive aggregate gross proceeds from the Private Placement of approximately $3.0 million, before deducting estimated offering expenses payable by the Company. The Company expects the net proceeds from the Private Placement to be used for advancement of the Company’s clinical development pipeline, business development activities, working capital and general corporate purposes.

The foregoing descriptions of the Securities Purchase Agreement and the Pre-Funded Warrants do not purport to be complete and are qualified in their entirety by reference to such agreements, copies of which are filed as Exhibits 10.1 and 4.1 hereto, respectively, and incorporated by reference herein.

Registration Rights Agreement
Also, on March 3, 2022, the Company entered into a registration rights agreement (the "Registration Rights Agreement") with the Investor, pursuant to which the Company agreed to register for resale the Shares and the shares of Common Stock underlying the Pre-Funded Warrants held by the Investor (the "Registrable Securities"). Under the Registration Rights Agreement, the Company has agreed to file a registration statement covering the resale of the Registrable Securities by no later than April 30, 2022 (the "Filing Deadline"). The Company has agreed to use commercially reasonable efforts to cause such registration statement to become effective as soon as practicable and to keep such registration statement effective until the date the Shares and the shares of Common Stock underlying the Pre-Funded Warrants covered by such registration statement have been sold or may be resold pursuant to Rule 144 without restriction. The Company has agreed to be responsible for all fees and expenses incurred in connection with the registration of the Registrable Securities.

In the event (i) the registration statement has not been filed by the Filing Deadline, (ii) the registration statement has not been declared effective prior to the earlier of (A) five business days after the date which the Company is notified by the U.S. Securities and Exchange Commission (the "SEC") that the registration statement will not be reviewed by the SEC staff or is not subject to further comment by the SEC staff, or (B) 60 days following the Filing Deadline (or, in the event the SEC reviews and has written comments to the registration statement, 120 days following the Filing Deadline) or (iii) after the registration statement has been declared effective by the SEC, sales cannot be made pursuant to the registration statement for any reason including by reason of a stop order or the Company’s failure to update such registration statement, subject to certain limited exceptions, then the Company has agreed to make pro rata payments to the Investor as liquidated damages in an amount equal to 1% of the aggregate amount invested by the Investor in the Registrable Securities per 30-day period or pro rata for any portion thereof for each such month during which such event continues, subject to certain caps set forth in the Registration Rights Agreement.
The Company has granted the Investor customary indemnification rights in connection with the registration statement. The Investor has also granted the Company customary indemnification rights in connection with the registration statement.

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to the Registration Rights Agreement, a copy of which is filed as Exhibit 10.2 hereto and incorporated by reference herein.

On March 3, 2022 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage specialty biopharmaceutical company, reported financial results for the full year of 2021 (Press release, DBV Technologies, MAR 3, 2022, View Source [SID1234609506]). The audit procedures have been substantially completed by the Company’s statutory auditors and financials were approved by the Board of Directors on March 3, 2022. The audit report will be issued by the Company’s auditors in March 2022.

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DBV has extended its cash runway into the first quarter of 2023 as a result of continued financial diligence and cost containment measures. These targeted efforts adequately support the critical research and development work underway to advance the Viaskin platform. The protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut ("mVP") patch was completed at the end of February 2022 and has been prepared for FDA submission. The Company is currently engaged in fruitful discussions with FDA in preparation for protocol submission and review. DBV expects to complete protocol submission following further alignment with FDA.

"Initiating our new Phase 3 trial with the mVP is our top priority. We are pleased with our ongoing exchanges with FDA. In parallel to these discussions, DBV continues to maximize the efficiency of its spend. Based on our current assumptions, we have extended our cash runway into the first quarter of 2023," said Daniel Tasse, Chief Executive Officer, DBV Technologies. "We expect that this cash position, combined with our continued discipline to reduce general and administrative expenses without sacrificing research and development, will give DBV sufficient time to gain alignment with FDA on the protocol for the mVP pivotal trial. DBV has been strategic in advancing its EPIT pipeline, and through these efforts, we aim to realize the full potential of the Viaskin technology for patients and families.

As of December 31, 2021, cash and cash equivalents were $77.3 million, compared to $196.4 million as of December 31, 2020. In 2021, cash used in operating activities was $(108.2) million under U.S. GAAP and $(104.1) million under IFRS compared to $(165.6) million under U.S. GAAP and $(160.9) million under IFRS in 2020.

The 35% decrease in net cash used in operating activities between the years ended December 31, 2021 and 2020 reflects the Company’s continued implementation of budget discipline measures.

Over the past 2 years, DBV reduced its net cash used in operating activities by 54%.

Net cash used in operating activities, including restructuring amounts paid as part of the global restructuring plan launched in June 2020 (in millions of $)

Cash flows used in investment activities were $(0.4) million in 2021, compared to $(2.9) million in 2020.

Cash from financing activities were $0.3 million under U.S. GAAP and $(3.9) million under IFRS compared to net cash flows provided by financing activities of $149.5 million under U.S. GAAP and $144.8 million under IFRS in 2020, including $150.0 million received in connection with DBV’s follow-on public offering of its securities in the first quarter of 2020.

DBV has continued to practice financial diligence and implemented further cost containment strategies. Based on its current operations, as well as its plans and assumptions as revised pursuant to its change of strategy announced in December 2021, DBV expects that its current cash and cash equivalents will support its operations into the first quarter of 2023.

Operating Income is primarily generated from DBV’s Research Tax Credit (French Crédit Impôt Recherche, or CIR) and from revenue recognized by DBV under its collaboration agreement with Nestlé Health Science. Operating income was $5.7 million, for the year ended December 31, 2021, compared to $11.3 million the year ended December 31, 2020. The decrease in operating income is primarily attributable to the revision of the revenue recognized under Nestlé’s collaboration agreement, as the Company updated its measurement of progress of its Phase II clinical study conducted as part of the contract due to recruitments’ delays.

Operating Expenses for the year ended December 31, 2021, were $104.3 million under U.S. GAAP and $104.0 million under IFRS, compared to $170.1 million under U.S. GAAP and $169.2 million under IFRS for the year ended December 31, 2020. The decrease in operating expenses for both periods is mainly attributable to the decrease in external clinical-related expenses and professional fees due to the budget discipline measures taken by DBV, as well as the decrease in employee-related costs, which is directly related to the workforce reduction DBV implemented as part of its 2020 global restructuring plan.

Excluding restructuring and share-based payments expenses, employee-related costs decreased by $19.2 million, from $42.0 million for the year ended December 31, 2020 to $22.7 million for the year ended December 31, 2021, under U.S. GAAP. Under IFRS, excluding share-based payments expenses, employee-related costs decreased by $19.5 million, from $42.3 million for the year ended December 31, 2020 to $22.8 million for the year ended December 31, 2021.

The average headcount decreased by 63% between the two periods, from 270 full-time equivalent employees for the year ended December 31, 2020 to 101 for the year ended December 31, 2021. As of December 31, 2021, DBV had 92 employees.

For the year ended December 31, 2021, net loss was $(97.8) million under U.S. GAAP and $(98.1) million under IFRS, compared to a net loss of $(159.6) million and $(159.7) million, respectively, for the year ended December 31, 2020.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(1.78) under U.S. GAAP and $(1.79) under IFRS for the year ended December 31, 2021.

Conference Call Information:

DBV will host a conference call and live audio webcast on Thursday, March 3, 2022, at 5:00 p.m. ET to report fourth quarter and full year 2021 financial results and review recent business updates.

This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50283860

A live webcast of the call will be available on the Investors & Media section of the Company’s website: View Source A replay of the presentation will also be available on DBV’s website after the event.

On March 3, 2022 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that the Company will host a conference call and webcast on March 10, 2022 at 4:30 pm ET (1:30 pm PT) to provide a business update and report fourth quarter and full year 2021 financial results (Press release, Corvus Pharmaceuticals, MAR 3, 2022, View Source [SID1234609505]).

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The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) and using the conference ID 13727689. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.