On November 3, 2022 IVERIC bio, Inc. (Nasdaq: ISEE) reported financial and operating results for the third quarter ended September 30, 2022 and provided a general business update (Press release, Ophthotech, NOV 3, 2022, View Source [SID1234623095]).

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"With the positive data from our GATHER2 clinical trial reported in the third quarter reinforcing the positive data from GATHER1, avacincaptad pegol (ACP) became the first and only investigational therapy in geographic atrophy (GA) to achieve its 12-month, prespecified, primary endpoint in two independent pivotal, Phase 3 clinical trials," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We are excited to announce that we are ahead of schedule in preparing our new drug application (NDA) for ACP for the treatment of GA and we are moving up our submission timeline to the end of this year."

"As we close out the year and look forward to 2023, we are working diligently to make ACP available to physicians and their patients with GA as expeditiously as possible, subject to regulatory review and approval," stated Pravin U. Dugel, MD, President of Iveric Bio. "We continue to build our U.S. launch readiness plan and prepare for potential commercialization of ACP. We also continue to explore future development opportunities for ACP in earlier patient populations and to invest in lifecycle initiatives such as sustained release delivery technologies for ACP."

Avacincaptad pegol (ACP also known as Zimura): Complement C5 Inhibitor
•In September 2022, the Company announced that GATHER2, the Company’s second Phase 3 clinical trial of ACP for the treatment of GA, met its pre-specified primary endpoint at 12 months with statistical significance and a favorable safety profile.

•Results from GATHER1, the Company’s first Phase 3 clinical trial of ACP for the treatment of GA, and GATHER2, as well as the Company’s Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), provide the basis for an NDA, which the Company plans to submit to the FDA by the end of this year. The Company is also planning to submit a marketing authorization application (MAA) to the European Medicines Agency in 2023, subject to feedback from planned interactions with regulatory authorities in Europe.

•The GATHER2 topline results for ACP were presented in two oral sessions as part of the Retina Subspecialty Day at the American Academy of Ophthalmology 2022 Annual Meeting on September 30, 2022.

•The Company recently initiated an open-label extension (OLE) trial for patients who completed their month 24 visits in the GATHER2 trial, with the aim of providing patients access to ACP and collecting additional safety data. Patients will be treated with ACP for 18 months or until potential regulatory approval of ACP in the applicable region, whichever is earlier.

•The Company received favorable feedback from the FDA on its development plans for intermediate AMD. The Company is continuing to engage with the FDA regarding its development plans and strategy for this important patient population.

•In July 2022, a post-hoc analysis from the GATHER1 clinical trial was presented at the Annual Meeting of the American Society of Retina Specialists. In the post-hoc analysis, ACP was observed to be associated with a reduction in GA lesion growth compared to sham across all distances from the foveal center point.

•Patient enrollment in STAR, the Company’s Phase 2b screening clinical trial of ACP for the treatment of autosomal recessive Stargardt disease (STGD1), is ongoing.

IC-500: HtrA1 (high temperature requirement A serine peptidase 1 protein) Inhibitor
•The Company plans to conduct additional preclinical studies to optimize formulation, dosage and delivery of IC-500. As a result, the Company does not expect to submit an investigational new drug application for IC-500 mid-next year, as it had previously planned. The Company remains committed to this program and will provide additional information as it becomes available.

Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)
•As the Company focuses its efforts and resources on the development and potential commercialization of ACP, the Company is currently seeking potential collaborators or licensees for the future development and potential commercialization of IC-100, the Company’s product candidate for Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) and IC-200, the Company’s product candidate for BEST1-Related IRDs.

•The Company is continuing its minigene programs for Leber’s Congenital Amaurosis type 10 (CEP290), autosomal recessive Stargardt Disease (ABCA4) and Usher’s Syndrome (USH2A).

Non-Dilutive Debt Financing Facility
In July 2022, the Company entered into a term loan debt financing facility with Hercules Capital, Inc. (Hercules Capital) and Silicon Valley Bank (SVB) providing the Company with total borrowing capacity of up to $250 million in non-dilutive debt financing. In July 2022, the Company borrowed $50 million at the close of the facility. The Company believes it has satisfied the first performance milestone under that term loan facility, which would allow it to borrow an additional $50 million. The Company plans to borrow this additional amount in the fourth quarter of 2022.

Third Quarter Financial Results and 2022 Cash Guidance

•As of September 30, 2022, the Company had $321 million in cash, cash equivalents and available for sale securities, which reflects the impact of its $50 million initial borrowing under its term loan debt financing facility with Hercules and SVB.

•The Company estimates its year-end 2022 cash, cash equivalents and available for sale securities to range between $265 and $275 million. The Company estimates that its cash, cash equivalents, available for sale securities and committed loan facilities will be sufficient to fund its planned capital expenditure requirements, debt service obligations and operating expenses through at least mid-2024. These estimates are based on the Company’s current business plan, including the continuation of its ongoing clinical development programs for ACP in GA and STGD1, including the recently initiated OLE trial, evaluating ACP for intermediate AMD, preparation and submission of an NDA and an MAA for ACP in GA, continuing preparations for potential commercialization of ACP in GA in the United States, pursuing DelSiTech’s silica-based sustained release delivery technology and exploring additional sustained release delivery technologies for ACP, and the advancement of its IC-500 development program as currently planned. These estimates do not include any potential new borrowings under the term loan facility with Hercules and SVB, including the $50 million that the Company plans to borrow in the fourth quarter of this year. Also excluded from these estimates

are any potential approval or sales milestones payable to Archemix Corp. or any potential expenses for actual commercial launch of ACP, such as associated sales force expenses, any additional expenditures related to potentially studying ACP in indications outside of GA, STGD1 and intermediate AMD, or resulting from the potential in-licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue.

2022 Q3 Financial Highlights

•R&D Expenses: Research and development expenses were $25.0 million for the quarter ended September 30, 2022, compared to $17.9 million for the same period in 2021. For the nine months ended September 30, 2022, research and development expenses were $81.2 million compared to $60.0 million for the same period in 2021. Research and development expenses increased primarily due to the continued progress of the Company’s GATHER2 trial, increased manufacturing activities for ACP, and increases in personnel costs, including share-based compensation associated with additional research and development staffing, offset by decreases in costs associated with the Company’s gene therapy programs.

•G&A Expenses: General and administrative expenses were $17.5 million for the quarter ended September 30, 2022, compared to $6.6 million for the same period in 2021. For the nine months ended September 30, 2022, general and administrative expenses were $45.8 million compared to $21.7 million for the same period in 2021. General and administrative expenses increased primarily due to increases in personnel costs, including share-based compensation associated with staffing for commercial preparation.

•Net Loss: The Company reported a net loss for the quarter ended September 30, 2022, of $42.4 million, or ($0.35) per diluted share, compared to a net loss of $24.6 million, or $(0.23) per diluted share, for the same period in 2021. For the nine months ended September 30, 2022, the Company reported a net loss of $126.2 million or ($1.05) per diluted share, compared to a net loss of $81.5 million or ($0.84) for the same period in 2021.

Conference Call/Webcast Information
Iveric Bio will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for November 3, 2022, at 8:00 a.m. Eastern Time. To participate in this conference call, dial 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 8170771. A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the Iveric Bio website at www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 1-877-344-7529 (USA Toll Free), passcode 6056402.

On November 3, 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 third quarter ended September 30, 2022 (Press release, NantHealth, NOV 3, 2022, View Source [SID1234623094]).

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"Net revenue was $16.6 million for the third quarter of 2022, representing the fourth consecutive quarter of top-line growth," said Ron Louks, Chief Operating Officer, NantHealth. "Moreover, our gross profit of $9.7 million and gross margin of 58 percent for the quarter were the highest since the fourth quarter of 2020.

"We expect to continue the positive momentum generated over the last several quarters. Recently, we signed a new customer, a leading provider of technology-enabled payment integrity, eligibility and related analytics services, to a four-year agreement for our NantHealth solutions. Importantly, we are also benefiting from a broadened product portfolio, with existing customers appreciating the value of our multiple solutions and services."

Software and Services Q3 Highlights:

Clinical Decision Support and Pre-Authorization (Eviti):
In October, secured a three-year contract extension with a large national commercial insurer providing coverage to over two million of their Medicaid members across multiple states. This client has opted to continue bringing unparalleled value to their operations by using Eviti Connect, and has used this renewal period to increase their solution set to include formulary redirection, further enabling value-based care
Announced Eviti Connect platform once again earned full URAC accreditation for Health Utilization Management through 2025. This designation demonstrates the highest level of commitment to quality healthcare
Maryland Physicians Care signed a two-year renewal agreement, ensuring it continues to receive a unique and tailored solution for its members with autoimmune diseases
Added new capability to Eviti Connect, which allows payer clients to comply seamlessly with state-mandated preferred drug lists, eliminating the need for manual reviews and secondary processing when those preferred drugs are prescribed
Payer Engagement (NaviNet):
Secured an agreement with an existing customer, one of America’s leading health insurance organizations, which added 750,000 new members to NaviNet
Went live with NaviNet Open Prior Authorization for a key customer. This capability is expected to streamline workflows and data collection to enable automated decisions and reduced manual processes. The initial deployment has been completed with further roll outs planned in Q4
Added new platform functionality to speed up the prior authorization process, enabling more timely patient care. Updates include the ability for health plans to add direct-to-provider information within the request
Network Monitoring and Management (The OpenNMS Group, Inc.):
Completed shipment of small form factor OpenNMS mini appliances for user testing. Highly optimized for secure, scalable, and reliable distributed monitoring via the OpenNMS Minion component, these hardware appliances provide visibility into remote or private areas of enterprise networks
Made significant progress toward the development of a capability that will let customers monitor infrastructures built using VMware SD-WAN. This initiative marks a significant milestone in the OpenNMS Managed Service Provider (MSP) support program
Delivered several service engagements positioning OpenNMS as strategically significant within the clients’ IT organizations. Clients included a large national retail chain, an entertainment streaming service, and a top wireless communication provider
Third quarter Financial Results: 2022 vs 2021

For the 2022 third quarter:

Total net revenue was $16.6 million compared with $14.4 million.
Gross profit was $9.7 million, or 58% of total net revenue, compared with $7.5 million, or 52% of total net revenue.
Selling, general and administrative (SG&A) expenses increased to $16.6 million from $13.0 million.
Research and development (R&D) expenses increased to $6.3 million from $4.6 million.
Net loss attributable to NantHealth was $13.7 million, or $0.12 per share, compared with $10.8 million, or $0.09 per share.
On a non-GAAP basis, net loss from continuing operations was $14.0 million, or $0.12 per share, compared with $11.5 million, or $0.10 per share.
At September 30, 2022, cash and cash equivalents totaled $0.6 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 third quarter ended September 30, 2022. The conference call will be available to interested parties by dialing 800-942-2493 from the U.S. or Canada, or 212-231-2931 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.

On November 3, 2022 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported third quarter 2022 financial results (Press release, NextCure, NOV 3, 2022, View Source [SID1234623093]).

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"Based on current efficacy data, we have decided to discontinue our clinical development of NC318. We will continue to support Yale University through its ongoing investigator initiated trial of NC318 in combination with pembrolizumab in lung cancer patients," said Michael Richman, NextCure’s president and chief executive officer. "We will focus our development efforts on the LAIR programs, including the recently initiated Phase 1b/2 combination trial of NC410 in solid tumors and the Phase 1 trial of NC525 that is expected to start in the first quarter of 2023. In addition, we have now initiated the NC762 expansion trial. These decisions are expected to add an additional 15 months to our cash runway and extend it into mid-2025."

Business Highlights

NC318 (S15 mAb)

●Based on the totality of the NC318 monotherapy data, including no responses in the amended Phase 2 portion of the trial, we have decided to discontinue development of our NC318 program.
●We will support Yale University’s ongoing NC318 investigator initiated combination trial.

NC410 (LAIR-2 fusion)

●Completed the Phase 1a dose escalation portion of the monotherapy trial and demonstrated that NC410 was safe and well tolerated.
●Initiated a Phase 1b/2 trial to evaluate NC410 in combination with pembrolizumab in patients with immune checkpoint refractory or naïve solid tumors.

NC525 (LAIR-1 mAb)

●Filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) and have received clearance to proceed with a Phase 1 trial.
●Plan to initiate a Phase 1 trial in the first quarter of 2023.
NC762 (B7-H4 mAb)

●Completed the Phase 1a dose escalation portion of the trial and demonstrated that NC762 was safe and well tolerated.
●Initiated the Phase 1b expansion trial.

Financial Guidance

●The decisions related to discontinuing NC318 and prioritizing NC410 in combination therapy are expected to add an additional 15 months to our cash runway.
●NextCure now expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into mid-2025.

Financial Results for Quarter Ended September 30, 2022

●Cash, cash equivalents, and marketable securities, excluding restricted cash as of September 30, 2022, were $169.2 million as compared to $219.6 million as of December 31, 2021. The decrease of $50.4 million primarily related to cash used to fund operations, cash used to purchase fixed assets, and changes in the fair value of our marketable securities.
●Research and development expenses were $13.5 million for the quarter ended September 30, 2022, as compared to $13.6 million for the quarter ended September 30, 2021.
●General and administrative expenses were $5.7 million for the quarter ended September 30, 2022, as compared to $4.9 million for the quarter ended September 30, 2021. The increase of $0.8 million primarily related to higher personnel-related costs.
●Net loss was $18.9 million for the quarter ended September 30, 2022, as compared with a net loss of $17.9 million for the quarter ended September 30, 2021. The change in net loss from the previous year’s quarter was primarily due to higher general and administrative expenses and lower interest income.

On November 3, 2022 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported its financial results for the third quarter ended September 30, 2022 and provided an update on recent developments (Press release, IGM Biosciences, NOV 3, 2022, View Source [SID1234623092]).

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"We have made substantial progress in advancing our IgM platform in the third quarter, particularly in expanding the body of evidence underlying our T cell engager portfolio for hematologic malignancies and in generating additional clinical data for IGM-8444. We continue to believe that each of our T cell engager product candidates has the potential to change the treatment paradigm in its respective indication. Notably, we are excited to share the first insight into the preclinical profiles of IGM-2644, our CD38 x CD3 bispecific IgM antibody, and IGM-2537, our CD123 x CD3 bispecific IgM antibody, during poster presentations at the upcoming ASH (Free ASH Whitepaper) meeting in December," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Additionally, today we are providing an update from the Phase 1 dose escalation trial of imvotamab in relapsed and/or refractory NHL describing its durable benefit for relapsed and/or refractory NHL patients. We look forward to sharing an initial Phase 2 efficacy and safety update for imvotamab and an initial efficacy and safety update on the FOLFIRI combination for IGM-8444 in Q1 2023."

Pipeline Updates

Imvotamab (CD20 x CD3)

Biomarker data from the Phase 1 trial evaluating imvotamab, the Company’s novel IgM T cell engaging bispecific antibody, selected for presentation at 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held virtually and in-person in New Orleans, Louisiana, December 10-13, 2022. The results will be presented on Sunday, December 11, 2022, at 6:00 p.m. CT, in a poster presentation titled "Pharmacodynamics and Biomarker Correlates of Imvotamab (IGM-2323), the First-in-Class CD20 x CD3 Bispecific IgM Antibody with Dual Mechanisms of Action, in Patients with Advanced B Cell Malignancies."

Biomarker data obtained from patients in dose escalation cohorts will be presented illuminating the relationship between T cell levels and response as well as pharmacodynamic data confirming T cell dependent (TDCC) and complement dependent (CDC) mechanisms of action for imvotamab in patients. Biomarker data (minimal residual disease data) to support durability of response will also be presented.

The ASH (Free ASH Whitepaper) abstract is available through the ASH (Free ASH Whitepaper) online meeting program.

Clinical development of imvotamab advances. IGM today provided an update on response duration from the Phase 1 dose escalation study of imvotamab in patients with relapsed and/or refractory (R/R) non-Hodgkin’s lymphoma (NHL).

In data previously reported at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, imvotamab showed a 50% complete response (CR) rate at the likely optimal 100 mg dose (n=10). Of the 28 patients treated in the titration dosing cohorts at that time, cytokine release syndrome was seen in less than 20% of patients.

Seven of eight complete response patients were tumor free after more than 1 year as of the data cut-off of August 31, 2022, and as of the data cut-off, the median overall duration of response in these patients had not yet been reached. All DLBCL patients with a complete response reported as of ASH (Free ASH Whitepaper) 2021 remained in complete response. Seven responding patients switched from weekly to Q3W therapy and all remain on study with sustained responses.

IGM expects to provide an initial Phase 2 efficacy and safety update for imvotamab in the first quarter of 2023.

Announced clinical trial collaboration and supply agreement with ADC Therapeutics SA. IGM expects to initiate clinical testing evaluating the combination of imvotamab and ZYNLONTA (loncastuximab tesirine-lpyl), ADC Therapeutics’ CD19-directed antibody drug conjugate (ADC), for the treatment of patients with R/R NHL in the first quarter of 2023.
IGM-2644 (CD38 x CD3)

Preclinical data for IGM-2644, the Company’s CD38 x CD3 bispecific IgM antibody, selected for poster presentation at 2022 ASH (Free ASH Whitepaper) Annual Meeting and Exposition. The results will be presented on Sunday, December 11, 2022, at 6:00 p.m. CT, in a poster presentation titled "IGM-2644, a Novel CD38 x CD3 Bispecific IgM T Cell Engager Demonstrates Potent Efficacy on Myeloma Cells with an Improved Preclinical Safety Profile."

Preclinical data will be presented that highlights the potency of IGM-2644 with potential activity in daratumumab resistant tumors and a preclinical safety profile with lower cytokine release and reduced T cell fratricide compared to other CD38 x CD3 bispecific T cell engagers.

The ASH (Free ASH Whitepaper) abstract is available through the ASH (Free ASH Whitepaper) online meeting program.

Phase 1 trial expected to initiate in first quarter of 2023. IGM expects to initiate a Phase 1 trial of IGM-2644 in multiple myeloma in the first quarter of 2023, subject to IND clearance.
IGM-2537 (CD123 x CD3)

Preclinical data for IGM-2537, the Company’s CD123 x CD3 bispecific IgM antibody, selected for poster presentation at 2022 ASH (Free ASH Whitepaper) Annual Meeting and Exposition. The results will be presented on Sunday, December 11, 2022, at 6:00 p.m. CT, in a poster presentation titled "CD123 Directed IgM Antibody-based T-cell Engager, IGM-2537, Demonstrates Potent in vitro and in vivo Activity with Minimal Cytokine Release."

Preclinical data will be presented highlighting potent in vitro and in vivo activity with minimal cytokine induction providing initial evidence of a favorable preclinical safety profile for a CD123 directed IgM-based T cell engager.

The ASH (Free ASH Whitepaper) abstract is available through the ASH (Free ASH Whitepaper) online meeting program.

IND application expected to be filed next year. IGM expects to file an IND application for IGM-2537 in acute myeloid leukemia in 2023.

IGM-8444 (DR5)

Clinical development of IGM-8444 advances. IGM continues to advance the clinical development of IGM-8444, the Company’s IgM DR5 agonist, in an open-label, multicenter, Phase 1 clinical trial in multiple combination treatment regimens in subjects with relapsed and/or refractory solid and hematologic cancers.

Expansion dosing ongoing in the FOLFIRI combination. IGM continues to enroll patients in an expansion of its 3 mg/kg FOLFIRI combination dose cohort in colorectal cancer patients, and it has recently further expanded this 3 mg/kg dose cohort to include treatment with IGM-8444 in combination with both bevacizumab and FOLFIRI in colorectal cancer patients. After completion of these 3mg/kg expansion cohorts, IGM expects to begin expansion of its 10 mg/kg FOLFIRI combination dose cohort. The Company expects to provide an initial efficacy and safety update on colorectal cancer patients treated with 3 mg/kg of IGM-8444 plus FOLFIRI in the first quarter of 2023.

Dosing ongoing in the fourth birinapant dose cohort. IGM is currently enrolling patients in the fourth planned birinapant combination dose escalation cohort.

IGM-7354 (IL-15 x PD-L1)

Phase 1 trial to initiate in the first quarter of 2023. IGM reported that it expects to dose the first patient in the Phase 1 trial for IGM-7354, IGM’s targeted IL-15 IgM antibody for the treatment of patients with solid and hematologic malignancies, in the first quarter of 2023, subject to IND clearance.

Preclinical data to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The poster, titled "IGM-7354, an anti-PD-L1/IL-15 IgM immunocytokine, activates and expands NK cells and effector memory CD8+ T cells in vivo" will be made available beginning at 9:00 a.m. ET on Thursday, November 10, 2022, through the SITC (Free SITC Whitepaper) online meeting program.

Corporate Updates

Albert Candia, Ph.D. appointed Senior Vice President of Preclinical Sciences. Dr. Candia brings over 22 years of biotechnology experience to IGM in both research and development in a variety of therapeutic areas and drug modalities. Prior to joining IGM, he was Vice President of Bioanalytical Development at Nektar Therapeutics, leading cross functional teams supporting clinical development and chemistry, manufacturing and control. Dr. Candia has also held previous positions at Dynavax Technologies and Xencor, where he oversaw IND enabling, translational and biomarker activities. Dr. Candia received his B.A. in Biology and Chemistry from Bucknell University and a Ph.D. in Cell Biology from Vanderbilt University School of Medicine.
Third Quarter 2022 Financial Results

Cash and Investments: Cash and investments as of September 30, 2022 were $469.1 million, compared to $229.5 million as of December 31, 2021.

Collaboration Revenue: For the third quarter of 2022, collaboration revenue was $0.3 million, compared to no revenue for the same period in 2021.

Research and Development (R&D) Expenses: For the third quarter of 2022, R&D expenses were $48.2 million, compared to $34.2 million for the same period in 2021.

General and Administrative (G&A) Expenses: For the third quarter of 2022, G&A expenses were $12.7 million, compared to $10.0 million for the same period in 2021.

Net Loss: For the third quarter of 2022, net loss was $58.0 million, or a loss of $1.32 per share, compared to a net loss of $44.2 million, or a loss of $1.32 per share, for the same period in 2021.

2022 Financial Guidance

IGM is updating its financial guidance and expects to end 2022 with a balance of more than $410 million in cash and investments and full year GAAP operating expenses of $240 million to $245 million including estimated non-cash stock-based compensation expense of approximately $45 million. IGM estimates full year collaboration revenue of approximately $1 million related to the Sanofi agreement.

On November 3, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported the acceptance of two poster presentations at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) 2022 Annual Congress, taking place in Geneva, Switzerland and online from December 7-9, 2022 (Press release, Poseida Therapeutics, NOV 3, 2022, View Source [SID1234623063]).

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Details of the presentations are as follows. The full abstracts will be made available on the ESMO (Free ESMO Whitepaper) website on December 1, 2022 at 12:05 AM CET.

About P-MUC1C-ALLO1
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in Phase 1 development for multiple solid tumor indications. Poseida believes P-MUC1C-ALLO1 has the potential to treat a wide range of solid tumors derived from epithelial cells, such as breast, colorectal, lung, ovarian, pancreatic and renal carcinomas, as well as other cancers expressing a cancer-specific form of the Mucin 1 protein, or MUC1-C. P-MUC1C-ALLO1 is designed to be fully allogeneic, with genetic edits to eliminate or reduce both host-vs-graft and graft-vs-host alloreactivity. Poseida has demonstrated the elimination of tumor cells to undetectable levels in preclinical models of both breast and ovarian cancer. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT05239143.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate, partnered with Roche, targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma in Phase 1 development. In vitro and in vivo P-BCMA-ALLO1 preclinical studies, showed effective, targeted cancer cell killing and cytokine secretion, with similar or superior anti-tumor efficacy compared to an autologous CAR-T therapy. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT04960579.