On November 2, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the third quarter of 2022 ended September 30, 2022, and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, NOV 2, 2022, View Source [SID1234622807]).

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"Today’s update highlights the value of our partnerships, which are validating our science, advancing and replenishing our clinical-stage pipeline, and satisfying a significant amount of our funding needs. AstraZeneca continues to advance our lead inhaled respiratory asset, elarekibep, while we continue to advance our lead IO bispecific program, PRS-344/S095012, in co-development with Servier. Furthermore, we are excited that Seagen and Boston Pharmaceuticals will soon initiate clinical development for their respective IO bispecifics programs, SGN-BB228 and PRS-342/BOS-342, which use Pieris’ platform technology. This clinical progress follows the recent phase 1 initiation of our fully proprietary inhaled respiratory program, PRS-220," said Stephen S. Yoder, President and CEO of Pieris. "We will continue to make disciplined pipeline investments that demonstrate our commitment to achieve inflection points in the next year within our partnered and proprietary programs."
Elarekibep and AstraZeneca Collaboration: AstraZeneca has completed enrollment of part 1b (safety of 10 mg cohort) and continues to enroll part 2 (efficacy of 3 mg cohort) of the multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated elarekibep (PRS-060/AZD1402), an IL-4 receptor alpha inhibitor Pieris is developing with AstraZeneca for the treatment of moderate-to-severe asthma. AstraZeneca has completed all submissions of the previously announced protocol amendments to improve enrollment. Topline results, which will include FEV1 improvement of the 3 mg cohort versus placebo, are expected to be reported by the third quarter of 2023. Upon delivery of these results, Pieris may choose to exercise its co-development option. Separately, Pieris will have a future option to co-commercialize elarekibep in the United States. Beyond elarekibep, Pieris continues to work on two discovery-stage programs with AstraZeneca, for which the research term was recently extended. Pieris retains co-development and U.S. co-commercialization options for these two programs.
PRS-344/S095012 and Servier Collaboration: Pieris and Servier continue to enroll the escalation portion of the phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 bispecific MabcalinTM (antibody-Anticalin fusion) compound for the treatment of solid tumors, for which Pieris holds full U.S. rights and will receive royalties on ex-U.S. sales by Servier. The companies expect to present data from the study at a medical meeting in 2023. Additionally, Servier is continuing development of PRS-352/S095025, an OX40/PD-L1 bispecific Mabcalin compound.
PRS-220: Pieris has dosed the first subject in the phase 1 study in healthy volunteers of PRS-220, a proprietary inhaled Anticalin protein targeting connective tissue growth factor (CTGF) for the treatment of IPF and other forms of fibrotic lung disease. The Company expects to report the outcome from the study in 2023. PRS-220 continues to benefit from a meaningful grant from the Bavarian government, which supports early-stage clinical development of this program.
Seagen Collaboration: The investigational new drug (IND) application for the phase 1 study of SGN-BB228 (also known as PRS-346), a first-in-class 4-1BB/CD228 bispecific Mabcalin compound, has been accepted. Seagen plans to initiate a phase 1 study for SGN-BB228 in the coming months, for which Pieris will receive a milestone payment. Seagen will also present preclinical data for the program at a poster session during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting. Seagen continues to develop a second undisclosed bispecific program under the companies’ immuno-oncology collaboration. Pieris has a multi-asset collaboration with Seagen and has an opt-in option to a U.S. co-promotion for one program in the collaboration.
PRS-342/BOS-342: Boston Pharmaceuticals continues to advance PRS-342/BOS-342, a 4-1BB/GPC3 bispecific Mabcalin compound, towards the clinic, with phase 1 expected to begin in the next six months.
PRS-400: Pieris unveiled and presented preclinical data for PRS-400, an inhaled Jagged-1 Anticalin protein the Company is developing for the treatment of muco-obstructive lung diseases, at the European Respiratory Society (ERS) International Congress 2022.
Second Quarter Financial Update:

Cash Position – Cash, cash equivalents, and investments totaled $69.8 million for the quarter ended September 30, 2022, compared to a cash and cash equivalents balance of $117.8 million for the year ended December 31, 2021. The decrease is due to funding operations in 2022. Including the proceeds from anticipated near-term milestones, the Company believes operations are sufficiently funded into the second quarter of 2024.

R&D Expense – R&D expenses were $13.6 million for the quarter ended September 30, 2022, compared to $18.9 million for the quarter ended September 30, 2021. The decrease is due to lower program costs, as work related to the Company’s sponsored phase 1 trial of elarekibep was largely complete in 2021, as well as due to lower manufacturing costs across all later-stage respiratory and immuno-oncology programs, and lower consulting costs. These lower costs were partially offset by higher clinical costs for PRS-344/S095012, higher pre-clinical costs for earlier stage programs, and an increase in personnel costs.

G&A Expense – G&A expenses were $3.9 million for the quarter ended September 30, 2022, compared to $4.1 million for the quarter ended September 30, 2021. The period-over-period decrease was driven primarily by lower personnel and legal costs, partially offset by higher professional services and travel costs.

Other Income – For the quarter ended September 30, 2022, $1.5 million of grant income was recorded with respect to PRS-220, compared to $1.8 million for the quarter ended September 30, 2021. The decrease is due to lower overall costs incurred this quarter on PRS-220.

Net Loss – Net loss was $9.7 million or $(0.13) per share for the quarter ended September 30, 2022, compared to a net loss of $16.5 million or $(0.24) per share for the quarter ended September 30, 2021.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Wednesday, November 2, 2022, to discuss the third quarter financial results and provide a corporate update. Individuals can join the call by dialing (888) 645-4404 (Toll Free US & Canada) or (862) 298-0702 (International). Alternatively, a listen-only audio webcast of the call can be accessed here.

For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.

On November 2, 2022 GlycoMimetics, Inc. (Nasdaq: GLYC), reported that it will host a conference call and webcast to report third quarter financial results on Wednesday, November 9, 2022, at 8:30 a.m. ET (Press release, GlycoMimetics, NOV 2, 2022, View Source [SID1234622806]).

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To access the call by phone, please go to this registration link and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

On November 2, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that members of its senior management team are scheduled to participate in the following upcoming investor conferences (Press release, Innate Pharma, NOV 2, 2022, View Source [SID1234622805]):

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Stifel 2022 Healthcare Conference, New-York
Evercore ISI 5th Annual HealthConX Conference

On November 2, 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 September 30, 2022 and provides a business update (Press release, INmune Bio, NOV 2, 2022, View Source [SID1234622804]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Q3 2022 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro and INB03):

●FDA review of Chemistry Manufacturing and Controls (CMC) associated with a recently placed clinical hold on XPro1595 AD trials is ongoing. The Company has addressed the FDA’s manufacturing procedure query and is in ongoing discussion to alleviate the current hold and start the US trials sites for XPro1595 in AD as a soon as possible.

●The Phase 2 trial in Mild AD patients continues to enroll in Australia. The first patient treated in the trial has completed the six-month study and has enrolled in the open label extension study.

●Opened a Special Access Scheme (SAS) in AUS for patients in the Phase I AD trial based on the demand from our patients that completed the 12-month extension trial.

INKmune Platform:

●The Company announced positive solid tumor data in multiple cancer lines resistant to natural killer (NK) killing that can be overcome with administration of INKmune by converting patient’s normal resting NK cells into potent memory-like NK cells that target solid tumors directly, even in the presence of immunosuppressive immunoregulatory cells and hypoxia associated with the tumor microenvironment (TME).

●The second UK clinical site is due to be initiated in November 2022 and a third UK site is under evaluation.

●The company completed a pre-IND discussion with the FDA and is preparing the IND to file with the FDA on a solid tumor indication.

Upcoming Events and Milestones:

●Initiate Xpro Phase 2 program for AD02 (mild AD) and AD03 (mild cognitive impairment) in US patients once clinical hold is lifted.

●Initiate XPro Phase 2 program for treatment resistant depression (TRD), funded in part by a $2.9 million NIH grant, once clinical hold is lifted.

●Initiate INKmune Phase 1/2 program in a solid tumor in 1H 2023.

●Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML in 2023.

●Report top-line data from Phase 2 trial of Xpro in AD03 patients. Timelines to be updated following resolution of FDA clinical hold.

●Report top-line data from Phase 2 trial of XPro in AD02 patients. Timelines to be updated following resolution of FDA clinical hold.

●Presentation at Society of Immunotherapy Conference (SITC) (Free SITC Whitepaper) on the use of DN-TNF to reshape the TME of trastuzumab resistant HER2+ breast cancer from a cancer protecting immunosuppressive TME to a TME that makes the tumor sensitive to immunotherapy.

●Presentation at San Antonio Breast Cancer Symposium (SABCS) demonstrating the addition of DN-TNF to Antibody Drug Conjugates (ADC) in HER2+ breast cancer improves the response of ADCs and suggests addition of DN-TNF may improve results in resistant tumors.

●Presentation of clinical data at ASH (Free ASH Whitepaper) (American Society of Hematology) from the INKmune trial.

"The first patient enrolled in the AD02 trial, a randomized, blinded, placebo-controlled study of XPro in patients with Mild Alzheimer’s Disease (AD) with biomarkers of neuroinflammation, has completed the six-month study," stated RJ Tesi, M.D., CEO of INmune Bio. "All patients that complete the six-month study will be eligible to receive XPro under a separate open label extension study. Our international, multicenter trial strategy has not changed and pending conclusion of the FDA’s XPro manufacturing inquiry, our plan to launch additional blinded, randomized, placebo-controlled Phase 2 trials in patients with mild cognitive impairment (MCI) and TRD will commence."

"Our INKmune platform continues to pivot towards solid tumors. Data presented at the Innate Killer Europe conference demonstrated the ability of INKmune-primed NK cells to fight solid tumors in the hostile environment of the TME. Improving NK cell therapeutic effectiveness in solid tumors such as prostate, renal cell, and nasopharyngeal cancer is an important unmet need in cancer therapy," concluded Dr. Tesi.

Two presentations using DN-TNF (INB03) to reverse resistance to immunotherapy will occur this quarter. In the animal models, DN-TNF changes the immunobiology of the tumor and TME to make them more susceptible to immunotherapy such as ADCs. Although much of the data are in MUC4+/HER2+ breast cancer, the data are relevant in gastric, pancreatic, and other malignancies expressing MUC4. "Despite advances in the treatment of HER2+ breast cancer with ADCs, 50% of women relapse after 24 months," added Dr. Tesi. "Combination with DN-TNF may provide these patients with additional therapeutic opportunities."

Financial Results for the Quarter Ended September 30, 2022:

Net loss attributable to common stockholders for the quarter ended September 30, 2022 was approximately $7.7 million, compared to approximately $9.5 million for the quarter ended September 30, 2021.

Research and development expense totaled approximately $5.2 million for the recent quarter compared to approximately $6.5 million during the quarter ended September 30, 2021.

General and administrative expense was approximately $2.4 million for the quarter compared to approximately $2.5 million during the quarter ended September 30, 2021.

Other expense was approximately $0.3 million for the quarter ended September 30, 2022 compared to approximately $0.4 million during the quarter ended September 30, 2021.

As of September 30, 2022, the Company had cash and cash equivalents of approximately $57.4 million.

As of November 2, 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

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through November 19, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13728541.

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.

On November 2, 2022 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following investor conferences in November 2022 (Press release, MacroGenics, NOV 2, 2022, View Source [SID1234622803]).

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BMO Biopharma Spotlight Series | Oncology Day (Virtual). Members of MacroGenics’ senior management team will participate in a fireside chat on Wednesday, November 9 at 2:30 pm ET. A replay link will be provided after the conference. MacroGenics’ management will also participate in one-on-one meetings.
Stifel 2022 Healthcare Conference (New York). MacroGenics’ President & CEO, Scott Koenig, M.D., Ph.D., will participate in a fireside chat on Tuesday, November 15 at 10:55 am ET. MacroGenics’ management will also participate in one-on-one meetings.
Evercore ISI 5th Annual HEALTHCONx Conference (Virtual). MacroGenics’ President & CEO, Scott Koenig, M.D., Ph.D., will participate in a fireside chat on Wednesday, November 30 at 8:50 am ET. MacroGenics’ management will also participate in one-on-one meetings.
Webcasts of the above may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company maintains archived replays of webcasts on its website for 30 days after the conference.