On March 28, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that Dr. Matt Coffey, President and Chief Executive Officer, will participate in the Novel Mechanisms with Important Readouts panel at Cantor Fitzgerald’s The Future of Oncology Virtual Symposium, which is taking place April 3-5, 2023 in a virtual format (Press release, Oncolytics Biotech, MAR 28, 2023, View Source [SID1234629446]). Additional details on the panel presentation can be found below.

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Date: Monday, April 3, 2023

Time: 11:00 a.m. ET

Panel Title: Novel Mechanisms with Important Readouts

A live webcast and archived replay of the panel presentation will be available to registered attendees of the symposium through the symposium website. Company management will also be participating in virtual one-on-one investor meetings at the symposium. To schedule a meeting, contact your Cantor Fitzgerald representative or email [email protected].

On March 28, 2023 NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells for liquid and solid malignancies, reported financial results for the fourth quarter and full year 2022 (Press release, NexImmune, MAR 28, 2023, View Source [SID1234629445]).

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"We remain confident in the potential therapeutic benefit of our AIM platform-based products amd their ability to significantly impact the emerging field of antigen specific immune-oncology therapies, novel IO combinations, autoimmune treatments and potential approaches for viral-driven diseases. While we are still observing patients in our ongoing cell therapy program, we are focused on advancing our AIM INJ ‘off-the-shelf’ modality," said Kristi Jones, Chief Executive Officer. "The combined data from our clinical cell therapy programs and INJ pre-clinical experiments are consistent, and we believe validate the AIM nanoparticles MOA regardless of modality. In addition, recent pre-clinical data combining AIM nanoparticle expanded multi-antigen specific T cells with a T cell bispecific engager demonstrated superior potency as well as enhanced persistence and durability supporting novel antigen specific IO combinations."

We believe that the AIM INJ therapeutic modality offers the most disruptive potential to benefit patients, as well as the greatest potential to create long-term value for our shareholders. The unique benefits of our "off the shelf" T cell targeted therapies include scalability and access to broader patient populations to address unmet need. We will provide an update on these programs over the coming months."

Jones continued, "Our AIM ACT cell therapy product candidates currently in clinical trials continue to show clinical activity in early dose escalation and are well-tolerated in patients. While paused, these clinical programs have demonstrated evidence of activity such as reduction in tumor burden, and a tolerability profile to support potential c novel IO combinations and to shift into patients with lower tumor burden. We are exploring external opportunities, including with academic centers and corporate collaborators, to advance these programs."

Select Fourth Quarter and Full Year 2022 Clinical and Business Highlights

Business and Strategy Update

Jerry Zeldis, MD, PhD, will retire from his position of Executive Vice President, R&D, effective March 31, 2023. Also, as part of the Company’s previous announced realignment of resources to focus on the AIM INJ platform and pause our cell therapy clinical programs, Bob Knight, MD, will step down from the position of Chief Medical Officer. Dr. Knight and Dr. Zeldis will transition to advisory roles and continue to provide both strategic counsel and fulfill operating responsibilities at NexImmune. Dr. Zeldis will also continue to be an active member on NexImmune’s Scientific Advisory Board.

"On behalf of the BOD, I want to thank Jerry and Bob for their leadership and contribution in bringing NexImmune’s revolutionary technology to the clinic and into patients. We are grateful for the continued support we will receive as both will remain involved with NexImmune in an active advisory capacity," said Sol Barer, NexImmune’s Chairman of the Board.

Clinical and Preclinical Updates

AIM INJ, Injectable "Off-the-shelf" Antigen-Specific Immunotherapy, and Other Preclinical Research

•Initiated multiple pre-clinical studies to evaluate monotherapy and in combination with a checkpoint inhibitor to support our oncology program

•Continued to evaluate AIM INJ nanoparticles as a therapeutic for type 1 diabetes as well as other autoimmune diseases with Yale University Professor Kevan Harold in partnership with JDRF

•Poster presented at 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR demonstrated evidence that AIM multi-antigen specific cells combined with a BCMA bispecific results in superior potency, enhanced persistence and durability in multiple myeloma models

•Publication in Frontiers in Medicine highlighting the ability of NexImmune’s AIM Platform to treat viral diseases

•Announced research collaboration with National Institute of Neurological Disorders and Stroke of the National Institutes of Health with initial focus on multiple sclerosis

•Announced neo-antigen melanoma research collaboration with NYU Langone’s Perlmutter Cancer Center
NEXI-001 Relapsed Refractory AML Post Allo-HSCT

•Full enrollment and dosing in the final safety cohort of NEXI-001 completed

•Plan to announce data for currently enrolled patients at or around an upcoming conference in mid-2023

•Continue to explore opportunities to advance NEXI-001 with potential collaborators and investigators

NEXI-003 HPV-Related Cancers

•Announced clearance of IND by the FDA for NEXI-003 for treatment of HPV-related cancers

•Continue to explore opportunities to develop this adoptive cell therapy with external partners and collaborators and develop a corporate HPV strategy that utilizes the AIM INJ modality.

Select 4Q and Full 2022 Financial Highlights

Cash, cash equivalents and marketable securities for the company as of December 31, 2022 were $34.6 million compared to $81.8 million at December 31, 2021. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its operating and capital expenditure requirements into the fourth quarter of 2023.

Research and development expenses were $13.7 million in the fourth quarter ended December 31, 2022, compared to $12.0 million for the same period in the prior year. Research and development expenses were $47.1 million for the full year period ended December 31, 2022, an increase of $9.6 million compared to $37.5 million for the full year ended December 31, 2021. The increase in R&D expenses was mainly attributable to costs for research related to preclinical manufacturing and the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $3.5 million for the fourth quarter ended December 31, 2022, which represent effectively no change for the same period in the prior year. General and administrative expenses were $15.9 million for the full year period ended December 31, 2022, an increase of $0.1 million compared to $15.8 million for the full year ended December 31, 2021. The increase was due primarily to an increase in fees related to professional and consulting services offset by decrease in headcount and stock compensation expense.
Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $16.9 million for the quarter and $62.5 million for the full year 2022, or a basic and diluted GAAP loss per share of $0.65 and $2.60 respectively. This compared to a net loss of $50.9 million, or a basic and diluted GAAP loss per share of $2.54, for the same period the prior year.

On March 28, 2023 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported its financial results for the year ended December 31, 2022 and provided an update on recent corporate highlights (Press release, Mereo BioPharma, MAR 28, 2023, View Source [SID1234629444]).

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"In 2022, we made important progress in the ongoing advancement of our core rare disease programs. The data from our Phase 2 ASTRAEUS study of alvelestat in severe alpha-1-antitrypsin deficiency-associated lung disease (AATD-LD) were highly encouraging, and formed the basis for productive discussions with the regulatory agencies in both the U.S. and EU, culminating in our recent announcement of the details of our potential pivotal study design," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "We believe our discussions with the regulatory agencies reflect the major unmet need for improved therapeutic options for these patients, and we expect that having this clear path to potential full U.S. and EU approvals based on guidance from both the FDA and EMA will support our ongoing partnering efforts. For our lead rare disease program, our partner Ultragenyx has continued to advance the development of setrusumab (UX143) for the treatment of osteogenesis imperfecta (OI), with completion of enrollment in the Phase 2 portion of the Phase 2/3 Orbit study in pediatric and adult patients and data is expected in mid-2023. Further, a study in younger pediatric patients is expected to initiate during the first half of 2023. We concluded 2022 with cash and short-term deposits of $68.2 million (£56.3 million) and maintain our expectation that we have sufficient runway to fund operations into 2026."

Highlights from 2022, Recent Developments and Anticipated Milestones

Alvelestat (MPH-966)

Received Fast Track Designation from the U.S. Food and Drug Administration (FDA).

Reported positive top-line biomarker data and a post-hoc analysis demonstrating an association between biomarker reductions and clinical outcomes in the Phase 2 ASTRAEUS study.

Received clear guidance from the FDA and European Medicines Agency (EMA) that a single 12-18 month placebo-controlled Phase 3 study in approximately 200 patients would be sufficient to support full marketing approvals in both the United States (U.S) and European Union (EU).

The independent primary endpoints of the proposed Phase 3 study are change in the St. George’s Respiratory Questionnaire (SGRQ) Activity domain, as guided by the FDA and change in lung density measured by CT scan, as guided by the EMA.

The Company is exploring potential partnerships to fund further development of alvelestat in AATD-LD.

Two abstracts were accepted to the American Thoracic Society (ATS) 2023 annual meeting, being held May 19-24.

Professor Robert Stockley, Chief Investigator on the ASTRAEUS study, will deliver an oral presentation on the ASTRAEUS study data.

A poster will be presented on the post-hoc analysis and association between biomarker reductions and improvement in SGRQ.

Data from the ongoing Phase 2 investigator-led study in AATD-LD (ATALANTA), including in patients who may be on augmentation therapy, is expected in Q3 2023.

Setrusumab (UX143)

Mereo’s partner Ultragenyx has completed enrollment in the Phase 2 portion of the Phase 2/3 Orbit study of setrusumab in OI patients aged five to 25. Data from the Phase 2 portion of this study is expected in mid-2023.

A study in younger patients comparing setrusumab to bisphosphonates is expected to be initiated by Ultragenyx in 1H 2023.

Etigilimab (MPH-313)

Enrollment in the Phase 1b/2 ACTIVATE trial has completed the Phase 1b part of the study, with a total of 76 patients enrolled. The totality of emerging data from ACTIVATE and key Phase 3 trials of other therapies targeting the TIGIT axis, particularly in NSCLC, will inform next steps for the etigilimab program, which is focused on gynecological malignancies and rare cancers. The Company expects to report additional data from the ACTIVATE study later in 2023.

Etigilimab, in combination with nivolumab, is also being studied in an ongoing investigator-led single-arm, open-label Phase 1b/2 trial in a subtype of platinum-resistant recurrent ovarian cancer (clear cell ovarian cancer) at The University of Texas MD Anderson Cancer Center (MD Anderson), financed by the Cancer Focus Fund. MD Anderson are planning to follow per protocol procedure to expand the study from an initial 10 patients to 20 patients.

Navicixizumab (OMP305B83)

Following regulatory interactions, Mereo’s partner, OncXerna, has stated its intention to initiate a Phase 3 trial of navicixizumab in late line ovarian cancer.

OncXerna is also dosing patients in a Phase 2 basket study evaluating navicixizumab, alone or in combination with chemotherapy, in patients with select advanced solid tumors.

Full Year 2022 Financial Results

Full year 2022 research and development expenses were £25.0 million, compared to £23.6 million, in 2021, an increase of £1.4 million, or 6%. R&D expenses relating to etigilimab increased by £2.3 million. The increase was due to the costs associated with additional patients and the duration of treatment for patients responding to therapy in 2022 compared to 2021 in the open label Phase 1b/2 basket study in combination with an anti-PD-1 in a range of tumor types. R&D expenses relating to alvelestat increased £0.1 million, or 2%, primarily reflecting the end of study related costs for the Phase 2 proof-of-concept study in AATD. Partially offsetting the increases, R&D expenses relating to setrusumab decreased by £0.2 million, or 7%. Setrusumab R&D expenditure in 2022 comprised activities associated with laying the groundwork for reimbursement discussions in Europe, and input into development, regulatory and manufacturing plans with our partner, Ultragenyx, as the global development of the program is funded by Ultragenyx pursuant to our licensing and collaboration agreement.

Administrative expenses increased by £3.6 million, or 23%, from £15.9 million in 2021 to £19.5 million in 2022. The increase was primarily driven by additional costs incurred in connection with the Schedule 13D filings and subsequent Cooperation Agreement with Rubric Capital, and increased share-based payment expenses, partially offset by a reduction in other professional fees.

Net loss attributable to equity holders for the year ended December 31, 2022 was £34.2 million, compared to a net profit of £12.7 million in 2021, primarily reflecting an operating loss of £43.6 million and a gain of £7.8 million due to changes in the fair value of financial instruments resulting from an unrealized gain on warrants.

As of December 31, 2022, the Company had cash and short-term deposits of £56.3 million ($68.2 million). Net cash burn during the fourth quarter of 2022 amounted to £11.2 million ($13.5 million). The Company expects its existing cash and short-term deposits will enable it to fund its currently committed clinical trials, operating expenses and capital expenditure requirements into 2026.

Total ordinary shares outstanding at December 31, 2022 were approximately 625 million. Total ADSs outstanding at December 31, 2022 were approximately 119 million, with each ADS representing five ordinary shares of the Company.

On March 28, 2023 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, a potential first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported its full year 2022 financial results (Press release, Infinity Pharmaceuticals, MAR 28, 2023, View Source [SID1234629442]). The Company previously announced on February 23, 2023 its execution of a definitive merger agreement with MEI Pharma for a strategic combination of Infinity and MEI, which is expected to close in mid-2023, subject to approvals by MEI Pharma and Infinity shareholders and other customary closing conditions.

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Infinity’s Full Year 2022 Financial Results:

At December 31, 2022, Infinity had total cash and cash equivalents of $38.3 million, compared to $80.7 million at December 31, 2021.
Research and development expenses for 2022 were $32.4 million, compared to $31.6 million in 2021. The increase is primarily related to an increase in compensation expenses due primarily to additional staff for the development of eganelisib and an increase in consulting, partially offset by a decrease in clinical development expenses.
General and administrative expenses were $13.5 million for 2022, compared to $14.2 million for 2021. The decrease in G&A expense is primarily due to a decrease in consulting and compensation expenses, partially offset by an increase in information technology support expenses.
Net loss for 2022 was $44.4 million, or a basic and diluted loss per common share of $0.50, compared to a net loss of $45.3 million, or a basic and diluted loss per common share of $0.53 in 2021.
Proposed Merger of Infinity Pharmaceuticals with MEI Pharma:

As previously announced (press release here) and as approved by the respective Boards of Directors of both companies, on February 23, 2023 MEI and Infinity entered into a merger agreement for an all-stock transaction with the intent to form a company combining the expertise and resources of MEI and Infinity to advance a robust pipeline of three clinical-stage oncology drug candidates. All three clinical-stage development programs have the potential, in combination with current therapies, to overcome known resistance mechanisms and meaningfully improve patient outcomes.

If the merger is consummated, the combined company is projected to have a ~$100M cash balance at closing which is expected to fund operations through mid-2025. Importantly, clinical data expected over the next 12 to 24 months from the combined company’s clinical-stage oncology development pipeline consists of three differentiated programs:

Eganelisib, an oral immuno-oncology macrophage reprogramming product candidate, which, subject to U.S. Food and Drug Administration review, is planned to be evaluated in combination with the PD-1 targeted checkpoint inhibitor pembrolizumab (KEYTRUDA) as first line therapy in patients with relapsed/metastatic head and neck squamous cell carcinoma (HNSCC). The primary endpoint of the Phase 2 study will be overall survival. In the second half of 2024 we plan to have initial data on safety and progression free survival.
Voruciclib, an oral CDK9 inhibitor, currently being studied in combination with venetoclax (VENCLEXTA) in patients with hematologic malignancies. MEI has provided guidance that the ongoing Phase 1b trial is expected to report initial results from the combination regimen around the end of 2023.
ME-344, a novel tumor selective mitochondrial inhibitor targeting the OXPHOS pathway, to be evaluated in combination with bevacizumab (AVASTIN) in patients with relapsed colorectal cancer. MEI has provided guidance that data from the Phase 1b trial to support opening enrollment in an expansion cohort are expected to be reported around the end of 2023.
In anticipation of the merger, Infinity is investing in merger-related activities, including transaction costs, in preparation for the potential initiation of a Phase 2 study of eganelisib in HNSCC, subject to FDA review, and corporate restructuring costs including severance and retention payments.

If the merger is not consummated, Infinity expects to have a cash runway on a stand-alone basis into the second half of 2023, compared to its most recent guidance of cash runway into 2024. This shorter cash runway is a result of expenditures related to merger activities and the advancement of eganelisib. If Infinity does not successfully consummate the merger, Infinity expects to evaluate strategic alternatives and if Infinity is unable to enter into another strategic transaction, the Company’s board of directors may conclude that it is in the best interest of stockholders to cease normal operations and wind down the Company through bankruptcy or dissolution proceedings.

Focus of Eganelisib Development Following the Proposed Merger as Announced on Feb 23, 2023:

Global Phase 2 Study of Eganelisib in Front Line Head and Neck Cancer Patients

The lead and most advanced program for the combined company is planned to be eganelisib. With data supporting multiple paths forward for eganelisib, a study in head and neck squamous cell carcinoma (HNSCC) was prioritized based on the ability to leverage encouraging progression-free survival data generated in head and neck cancer patients in Infinity’s MARIO-1 clinical trial. In addition to the encouraging data from MARIO-1, the planned initiation of a randomized, controlled Phase 2 clinical study combining eganelisib with pembrolizumab or pembrolizumab in front line recurrent metastatic HNSCC patients was prioritized because:

Pembrolizumab is an approved standard of care in the study population and an appropriate control arm for the study.
Patients with recurrent or metastatic HNSCC with a PD-L1 combined positive score of 1 or greater have relatively short median progression free survival (3.2 months) and median overall survival (12.3 months) when treated with pembrolizumab monotherapy (Burtness et al Lancet 2019).
We believe that the combination regimen of eganelisib plus pembrolizumab has the potential to demonstrate progression free survival and overall survival benefits for front line recurrent metastatic HNSCC patients in a reasonably short period of time.
There are a significant number of patients in need.
Eganelisib data in HNSCC Patients from MARIO-1 Study:

The prioritized HNSCC Phase 2 study follows an encouraging signal from our MAcrophage Reprogramming in Immuno-Oncology-1, or MARIO-1, study, a Phase 1/1b clinical study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity for eganelisib — both as a monotherapy and in combination with nivolumab — in 224 patients with advanced solid tumors. As of the study’s December 13, 2021 database lock, the median progression free survival, or mPFS, rate of 3.7 months (1.9, 5.5) was observed in the HNSCC cohort in patients with immediate prior progression on CPI therapy. The mPFS for all patients receiving pembrolizumab monotherapy was 2.3 months in KEYNOTE-048, the benchmark study investigating pembrolizumab monotherapy, pembrolizumab plus chemotherapy, or cetuximab plus chemotherapy as a first-line therapy in recurrent or metastatic HNSCC patients. However, we caution you that the risks in cross-trial comparisons limit our ability to reach definitive conclusions without a prospective, adequately powered, randomized controlled trial. Further, in MARIO-1, a disease control rate, or DCR, of 36.4% (4 of 11 patients), an overall response rate, or ORR, of 18.2% (2 of 11 patients), and an mPFS rate of 5.3 months (1.9, 11.1) were observed in the HNSCC cohort in patients with immediate prior progression on CPI therapy and two or fewer prior lines of therapy. Reversible hepatic and skin adverse events were the most common toxicities observed when eganelisib was combined with nivolumab in patients across all combination cohorts of the MARIO-1 study in patients with advanced solid tumors.

Encouraging data with eganelisib has been generated in other patient populations including in patients with front-line metastatic triple negative breast cancer, or mTNBC, from the MARIO-3 TNBC study, and in CPI-naïve platinum refractory second line urothelial cancer patients in the MARIO-275 study, as summarized in the Company’s Annual Report on Form 10-K for 2022 filed on March 28, 2023.

On March 28, 2023 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported financial results and recent business highlights for its fourth quarter ended December 31, 2022 (Press release, HCW Biologics, MAR 28, 2023, View Source [SID1234629441]).

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Hing C. Wong, Ph.D., Founder and CEO of HCW Biologics, stated, "We had a productive year in 2022, and our cancer program met or exceeded key milestones. In the fall, a preliminary first-in-human clinical data readout was presented at the SITC (Free SITC Whitepaper) annual conference by Dr. Melissa Geller, the principal investigator for the University of Minnesota ("UMN") sponsored Phase 1 clinical trial to evaluate HCW9218 in solid tumors. We are encouraged by data gathered in this study and believe that it shows the potential of HCW9218 in the treatment of solid tumors, especially ovarian cancer. Our data indicates that HCW9218 is functioning as it was intended – activating the immune system and capturing TGF-β 1, 2 and 3 with no evidence of mucosal bleeding."

Dr. Wong continued, "UMN has been a terrific sponsor and partner for the Phase 1 solid tumor clinical study. With Dr. Geller’s expertise and focus, along with the support of the co-principal investigator, Dr. Jeff Miller, the Phase 1 portion of this trial is on track to be completed within a year of its initiation, which is fortunate in the times of prolonged COVID-related delays. Because of this, we are poised to complete the Phase 1 study in 2023 and, if our studies are successful, potentially advance into Phase 2 clinical trials in 2023."

In the fourth quarter of 2022, the Company also initiated a Company-sponsored Phase 1b/2 clinical trial to evaluate HCW9218 in advanced pancreatic cancer. Dr. Wong stated, "With respect to HCW9218, we believe cancer is our gateway indication to other age-related diseases. As and to the extent we advance the clinical development to evaluate HCW9218 in cancer indications, we intend to focus on two of the most difficult-to-treat cancers that have no therapeutic remedy today: ovarian cancer and pancreatic cancer." He added, "If we can establish safety and dosage of HCW9218 in cancer indications, we plan to expand to other age-related diseases promoted by inflammaging."

One of the pillars of the Company’s strategy is its commitment to documenting its work in high-impact scientific journals. Two scientific papers were submitted in 2022, one has been published, and the other has been accepted for publication. Dr. Wong stated, "We devote significant resources to publishing scientific papers, because we believe in the value of sharing our discoveries and inventions with the broader scientific community."

Dr. Wong continued, "Our most recent paper published in Frontiers in Immunology illustrates the potential for HCW9302 as a therapeutic agent to expand and activate Treg cells indicating it might be effective in treating inflammatory and autoimmune diseases. HCW9302 is a unique fusion protein with two IL-2 domains linked by an extracellular tissue factor domain that has been shown in preclinical research to exhibit a more favorable pharmacokinetic profile than recombinant IL-2, with longer half-life, greater affinity to IL-2 receptor α and no toxicity. The results of our research included in this publication show the potential of HCW9302 in the treatment of age-related inflammatory diseases, such as atherosclerosis."

Fourth Quarter and Other Recent Business Highlights:

On November 11, 2022, there was a preliminary human data readout at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) from an ongoing Phase 1 clinical trial to evaluate HCW9218 in patients with chemo-refractory/chemo-resistant solid tumors, sponsored by the Masonic Cancer Center, University of Minnesota. The poster was presented by Melissa A. Geller, M.D., M.S., Principal Investigator, who is a Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women’s Health at the University of Minnesota.
•
On December 3, 2022, under a Cooperative Research and Development Agreement ("CRADA"), the National Cancer Institute and HCW Biologics agreed to collaborate to perform a Phase 1b/2 clinical study to evaluate the safety and tolerability of HCW Biologics’ lead product candidate, HCW9218, in patients with advanced/metastatic pancreatic cancer. The CRADA is entitled, "A Phase 1b/2 Study of HCW9218, a Bifunctional TGF-β Antagonist/IL-15 Protein Complex, for Advanced Pancreatic Cancer."
•
HCW Biologics initiated a Company-sponsored Phase 1b/2 clinical study to evaluate HCW9218 in patients with advanced pancreatic cancer. With four clinical sites up and running, if patient enrollment continues at the current pace, the Company expects to complete the Phase 1b portion of this study in 2023.
•
In January 2023, a pivotal scientific paper authored by members of the Company’s scientific research team was published in the high-impact, peer-reviewed journal, Frontiers in Immunology, entitled, "A Novel Interleukin-2-Based Fusion Molecule, HCW9302, Differentially Promotes Regulatory T Cell Expansion to Treat Atherosclerosis in Mice."
•
The Company has been invited to present a poster at the American Association of Cancer Research to be held from April 14-19, 2023. Dr. Varghese George, one of the Company’s scientists, will be presenting a poster entitled, "Bifunctional Immunotherapeutic HCW9218 Facilitates Recruitment of Immune Cells from Tumor Draining Lymph Nodes to Promote Antitumor Activity and Enhance Checkpoint Blockade Efficacy in Solid Tumors." This research is intended to support the understanding of the mechanism of action for HCW9218 for solid tumors.

Fourth Quarter and Full Year 2022 Financial Results:

Cash and cash equivalents: As of December 31, 2022, the Company held $22.3 million in cash and cash equivalents, including money market investments, and $9.7 million in U.S. government backed securities presented as short-term investments. Money market investments are held in a federal money market fund with an investment focus on liquidity and stability.

Revenues: Revenues for the fourth quarter ended December 31, 2021 and 2022 were nil and $1.3 million, respectively. Revenues for the year ended December 31, 2021 and 2022 were nil and $6.7 million, respectively. Revenues were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen.

Research and development (R&D) expenses: R&D expenses for the fourth quarter ended December 31, 2021 and 2022 were $1.5 million and $2.9 million, respectively. The $1.4 million increase, or 98%, resulted from increased clinical trial expenses and manufacturing costs. R&D expenses for the year ended December 31, 2021 and 2022 were $8.2 million and $9.3 million, respectively. The $1.1 million increase, or 14%, resulted from increases in salaries, performance-based bonuses, and clinical trial expenses.

General and administrative (G&A) expenses: G&A expenses for the fourth quarter ended December 31, 2021 and 2022 were $1.6 million and $3.0 million, respectively. The $1.4 million increase, or 84%, was attributable to increases in salaries and stock-based compensation and professional fees related primarily to legal fees. G&A expenses for the year ended December 31, 2021 and 2022 were $5.2 million and $8.3 million, respectively. The $3.1 million increase, or 60%, resulted from increases in stock-based compensation expense for officers and directors, legal fees, and additional costs of operating as a public company.

Net loss: Net loss for the fourth quarter ended December 31, 2021 and 2022 was $3.2 million and $5.4 million, respectively. Net loss for the year ended December 31, 2021 and 2022 was $12.9 million and $14.9 million, respectively.

Financial Guidance

HCW Biologics believes its cash and cash equivalents and investments will be sufficient to fund its operations through at least the next 12 months. This cash runway guidance is based on the Company’s current operational plans and buildout of its new headquarters building, and it excludes any additional capital infusion resulting from bank loans, joint ventures, out-licenses, or other business development transactions. Relocation to the new headquarters is anticipated during 2024, although the Company may choose to delay the completion date to extend its cash runway. In the year ended December 31, 2022, the Company incurred significant legal expenses on its own behalf and on behalf of Dr. Wong, as required by the indemnification agreement between the Company and Dr. Wong. In the year ahead, the Company expect to continue to incur legal expenses on its own behalf in connection with the legal proceedings brought against it by Altor/NantCell. However, now that the arbitration against Dr. Wong was initiated by Altor/NantCell, Dr. Wong’s legal expenses will be covered by the provisions of his advancement agreement with Altor/NantCell in connection with the arbitration.