On August 9, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the second quarter ended June 30, 2022, and provided a business update (Press release, Janux Therapeutics, AUG 9, 2022, View Source [SID1234617921]).

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"In recent months, we have maintained momentum across our portfolio of novel immunotherapies, receiving FDA clearance to advance JANX007, our lead PSMA-TRACTr product candidate, into the clinic, and advancing IND-enabling studies for our preclinical pipeline of TRACTr and TRACIr candidates," said David Campbell, Ph.D., President and CEO of Janux. "We are excited to have evolved into a clinical-stage company with the expected initiation of a Phase 1 trial of JANX007 for metastatic castration-resistant prostate cancer and look forward to additional upcoming IND submissions, including one for JANX008, our EGFR-TRACTr candidate, in the second half of this year. We look forward to executing on our near-term milestones and advancing our pipeline of novel immunotherapies for cancer patients."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

TRACTr candidate pipeline advancing with a Phase 1 clinical trial for JANX007 expected to initiate in 2H 2022 and an IND submission for EGFR-TRACTr (JANX008) in 2H 2022.
Janux recently announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application for its lead product candidate, JANX007, a PSMA-TRACTr in development for the treatment of metastatic castration-resistant prostate cancer (mCRPC). A Phase 1 clinical trial of JANX007 is expected to initiate in 2H 2022.
Janux plans to submit an IND application to the FDA for its EGFR-TRACTr (JANX008) in 2H 2022. CGMP manufacturing of both drug substance and drug product has been completed to support the IND and supply first-in-human clinical trials.
Janux plans to submit an IND application to the FDA for its TROP2-TRACTr in 2023.
IND-enabling studies ongoing for the first TRACIr development candidate, a PD-L1xCD28 costimulatory bispecific for the treatment of solid tumors.
Janux expects to submit an IND application to the FDA for its PD-L1xCD28 TRACIr in 2023. Janux has initiated CGMP manufacturing activities and is on-track to support production and release of drug substance and drug product to support an IND filing in 2023.
SECOND QUARTER 2022 FINANCIAL HIGHLIGHTS:

Cash and cash equivalents and short-term investments: As of June 30, 2022, Janux reported cash and cash equivalents and short-term investments of $354.3 million, compared to $375.0 million at December 31, 2021.
Research and development expenses: Research and development expenses for the quarter ended June 30, 2022, were $14.1 million, compared to $4.7 million for the comparable period in 2021.
General and administrative expenses: General and administrative expenses for the quarter ended June 30, 2022, were $5.5 million, compared to $2.0 million for the comparable period in 2021.
Net loss: For the quarter ended June 30, 2022, Janux reported a net loss of $16.9 million, compared to a net loss of $6.2 million for the comparable period in 2021.

On August 9, 2022 Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation and immunologic diseases, including complement-mediated diseases and cancers, reported recent highlights and developments as well as financial results for the second quarter ended June 30, 2022, which include (Press release, Omeros, AUG 9, 2022, View Source [SID1234617920]):

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For the quarter ended June 30, 2022, Omeros earned royalties of $17.2 million on net sales of the company’s former ophthalmology product OMIDRIA. Royalties earned in the quarter represent 50 percent of net sales of OMIDRIA by Rayner Surgical, Inc. (Rayner), which purchased Omeros’ ophthalmology assets in December 2021. Rayner’s reported net sales of $34.5 million for the second quarter of 2022, all of which were in the U.S., establish a new all-time high for quarterly OMIDRIA sales and represent a $5.7 million increase over net sales of $28.8 million reported by Omeros for the second quarter of last year.
Net loss in 2Q 2022 was $30.9 million, or $0.49 per share, which included $3.7 million of non-cash expenses, or $0.06 per share. This compares to a net loss of $28.6 million, or $0.46 per share for the prior year quarter, which included $3.9 million of non-cash expenses, or $0.06 per share.
At June 30, 2022, Omeros had $122.6 million of cash, cash equivalents and short-term investments available for operations, which is a reduction of $19.7 million from March 31, 2022. In addition, Omeros had $14.5 million in net receivables available for operations at June 30, 2022.
In June 2022, Omeros submitted to the United States Food and Drug Administration (FDA) a request for Formal Dispute Resolution regarding the Complete Response Letter (CRL) issued by FDA last year regarding the Company’s biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Formal dispute resolution is an official pathway that enables a sponsor to appeal a decision by an FDA division to a higher authority within FDA, in this case the Office of New Drugs (OND). Last month, in accordance with the standard dispute resolution procedure, Omeros had a formal meeting with the OND official assigned to decide the dispute. A decision is expected in August 2022.
"We remain confident that approval of narsoplimab in TA-TMA is warranted, and we look forward to OND’s decision later this month," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "In addition to FDA’s decision on narsoplimab approval, a series of value-driving milestones have aligned over the next few quarters: data from our Phase 3 trial of narsoplimab in IgA nephropathy are on track for readout by mid-next year; our MASP-3 inhibitor OMS906 is starting trials in PNH and C3 glomerulopathy with efficacy data targeted by early next year; about that same time, we expect data from our Phase 1 trial of OMS1029, our long-acting MASP-2 inhibitor, which began dosing earlier this week; also in early 2023, our PDE7 inhibitor OMS527 should have data available in a clinically predictive primate model of levodopa-induced dyskinesias; and, with separate payment for OMIDRIA reconfirmed by CMS in its recently released proposed rule for the Outpatient Prospective Payment System, we expect continuing growth in our royalty stream and, should OMIDRIA obtain long-term reimbursement, to secure the $200-million milestone payment."

Second Quarter and Recent Clinical Developments

Recent developments regarding narsoplimab, Omeros’ lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in advanced clinical programs for the treatment of TA-TMA, immunoglobulin A (IgA) nephropathy, atypical hemolytic uremic syndrome (aHUS) and severely ill COVID-19 patients, include the following:
Enrollment in Omeros’ Phase 3 ARTEMIS-IGAN trial continues to progress toward an anticipated readout of 9-month data on proteinuria by mid-next year.
The Omeros teams in Cambridge, UK and Seattle recently published two manuscripts detailing the company’s latest COVID-19-related discoveries, the first by Ali et al. in Frontiers in Immunology and the second by Lynch et al. in Clinical and Translational Medicine. Together, these publications describe the findings that:
Patients with severe COVID-19 early in disease show marked complement consumption driven by lectin pathway hyperactivation, causing secondary hypocomplementemia and loss of complement-mediated immune protection against microbial infection. This hypocomplementemia increases the risk of clinically severe infections, a common cause of morbidity and death in COVID-19.
Narsoplimab restores complement function and bactericidal activity, preventing risk of secondary infection.
Narsoplimab is also being evaluated for the treatment of hospitalized COVID-19 patients in the I-SPY COVID-19 platform trial sponsored by Quantum Leap Healthcare Collaborative (QLHC). Omeros looks forward to QLHC’s disclosure of the narsoplimab results.
Recent developments regarding OMS906, Omeros’ lead monoclonal antibody targeting MASP-3, the key activator of the alternative pathway, and OMS1029, the company’s long-acting, next-generation MASP-2 inhibitor, include the following:

In July, OMS906 received designation from FDA as an orphan drug for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Orphan-drug designation is granted by FDA to encourage development of a drug that targets a condition affecting fewer than 200,000 U.S. patients annually. The benefits of orphan drug designation include seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.
To accelerate obtaining OMS906 efficacy data, in addition to the Phase 1b trial expected to begin enrolling soon and evaluating OMS906 in patients with PNH who have had an unsatisfactory response to the C5 inhibitor ravulizumab, Omeros is expanding its program of OMS906 clinical trials to include treatment-naïve PNH patients and complement 3 (C3) glomerulopathy patients as well as one or more related indications. Efficacy data in these indications are targeted by early 2023.
Omeros has submitted an abstract describing the results of the OMS906 Phase 1 study for presentation at a major medical congress later this year. Preliminary results from the Phase 1 study were previously reported and no safety signals of concern were noted.
A Phase 1 clinical trial assessing safety, tolerability and pharmacokinetics/pharmacodynamics (PK/PD) of OMS1029 in healthy subjects is underway, with the first dose administered earlier this week. Designed for convenient dosing, OMS1029 is expected to enable Omeros to pursue a range of indications complementary to those for narsoplimab. Based on animal PK/PD data to date, dosing in humans is expected to be once-monthly to once-quarterly by subcutaneous or intravenous administration.
Financial Results

On December 23, 2021, Rayner acquired OMIDRIA and certain related assets and liabilities. The completion of the sale required Omeros to reclassify all revenues and expenses related to OMIDRIA as discontinued operations for fiscal year 2021 in its financial statements.

During the second quarter of 2022, Omeros earned royalties of $17.2 million on sales of OMIDRIA, which were recorded as a reduction from the OMIDRIA contract royalty asset. The company also recorded $10.1 million of income in discontinued operations, primarily representing interest income and remeasurement adjustments to the OMIDRIA contract royalty asset.

Total costs and expenses for the second quarter of 2022 were $37.4 million compared to $45.6 million for the second quarter of 2021. The decrease was primarily due to the timing of narsoplimab manufacturing activities and a reduction in U.S. TA-TMA pre-launch activities.

Net loss was $30.9 million in the second quarter of 2022, or $0.49 per share, which included $3.7 million of non-cash expenses, or $0.06 per share. This compares to a net loss of $28.6 million, or $0.46 per share, including $3.9 million of non-cash expenses, or $0.06 per share, in 2Q 2021.

As of June 30, 2022, the company had $122.2 million of cash, cash equivalents and short-term investments with an additional $14.5 million in receivables, net.

Conference Call Details

To access the live conference call via phone, please dial (833) 634-2592 from the United States and Canada or (412) 902-4100 internationally and ask to be placed into the Omeros earnings call. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (877) 344-7529 from the United States, (412) 317-0088 internationally, and (855) 669-9658 from Canada. The replay access code is 4990130.

For online access to the live or subsequently archived webcast of the conference call, go to Omeros’ website at View Source

On August 9, 2022 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the second quarter ended June 30, 2022 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, AUG 9, 2022, View Source [SID1234617919]).

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"We remain steadfast in our commitment to accelerate the clinical development of our lead candidates, ZN-c3 and ZN-d5, and we took many important steps this quarter – including continuing to strengthen our leadership team and cash position – to help reach this goal," commented Dr. Kimberly Blackwell, Chief Executive Officer of Zentalis. "To that end, we are excited to receive financial and strategic support from Pfizer, whose commitment will help us to realize the full potential of ZN-c3, a selective Wee1 inhibitor designed to induce synthetic lethality in cancer cells. We look forward to sharing updates on our ongoing and planned trials later this year."

Program Highlights:

The Company is focusing its resources on investigating the full potential of its lead clinical candidates ZN-c3, its Wee1 inhibitor, and ZN-d5, its BCL-2 inhibitor, as monotherapies and in combination across a wide range of cancers. Therefore, Zentalis will discontinue the clinical development of ZN-c5, its oral SERD, and ZN-e4, its EGFR inhibitor, following completion of its existing clinical trials, which are closed to accrual, in these two programs.
In April 2022, Zentalis presented five abstracts at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and held a webcast event with Key Opinion Leader, Dr. Kathleen Moore, to further discuss the clinical and preclinical data presented at the conference, with additional details available here.
Corporate Highlights:

In April 2022, Zentalis sold 953,834 of its common shares at a price of $26.21 per share to Pfizer for gross proceeds of approximately $25.0 million. Zentalis and Pfizer plan to jointly advance the clinical development of ZN-c3. In addition, Dr. Adam Schayowitz, Vice President & Medicine Team Group Lead for Breast Cancer, Colorectal Cancer and Melanoma, Pfizer, joined Zentalis’ Scientific Advisory Board.
In May 2022, the Company closed an underwritten public offering of 10,330,000 shares of its common stock at a public offering price of $19.38 per share. The total gross proceeds were approximately $200.2 million.
In May 2022, the Company appointed Kimberly Blackwell, M.D., an oncology clinical development veteran, as Chief Executive Officer. Dr. Blackwell has been a member of Zentalis’ Board since 2020 and previously served as Chief Medical Officer of Tempus Labs. Before that, she held clinical development leadership roles at Eli Lilly and Company. Additionally, Board member Dave Johnson was appointed Chairman and Cam Gallagher, MBA, a cofounder of Zentalis, was promoted to President and will remain a Board member.
In July 2022, Zentalis announced the appointment of Andrea Paul, J.D., as General Counsel and Corporate Secretary.
Second Quarter 2022 Financial Results

Cash and Marketable Securities Position: As of June 30, 2022, Zentalis had cash, cash equivalents and marketable securities of $455.2 million. The Company believes that its existing cash, cash equivalents and marketable securities as of June 30, 2022 will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2025.
Research and Development Expenses: Research and development expenses for the three months ended June 30, 2022 were $43.8 million, compared to $44.8 million for the three months ended June 30, 2021. The decrease was primarily due to licensing milestones and manufacturing expenditures incurred during the three months ended June 30, 2021, which did not recur during the comparable period in 2022.
General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2022 were $19.6 million, compared to $10.4 million during the three months ended June 30, 2021. The increase in expenses was primarily attributable to an increase in non-recurring, non-cash stock-based compensation and other cash compensation.

On August 9, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported financial results for the quarter ended June 30, 2022 (Press release, Allogene, AUG 9, 2022, View Source [SID1234617918]).

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"We feel confident that we could soon initiate the industry’s first Phase 2 pivotal trial for an allogeneic CAR T product, thereby paving the road not just for ALLO-501A, but our entire portfolio," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "As the use of autologous CAR T therapy increases, we are seeing a greater need for an off-the-shelf, allogeneic CAR T option. We are keenly aware of the devastating consequences patients face when only a minority are able to access the curative potential of CAR T therapy. Clinicians have been forced into the unfathomable position of needing to choose which of their patients will receive this potentially life-saving therapy. As patients face access bottlenecks, we are determined to transform CAR T therapy from a complex individualized procedure to an off-the-shelf, on demand pharmaceutical product."

Pipeline Updates

CD19 Program

In the coming weeks, the Company expects to receive clearance from the U.S. Food and Drug Administration (FDA) to initiate a potential Phase 2 pivotal clinical trial for ALLO-501A in relapsed/refractory (r/r) large B cell lymphoma (LBCL). This includes meeting Chemistry Manufacturing and Controls (CMC) requirements to use ALLO-501A from its manufacturing facility, Cell Forge 1.

In June, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL. RMAT designation was based on data demonstrating the potential of ALLO-501A to address the unmet need for patients who have failed other therapies. Previously presented data support the potential of ALLO-501A to provide a safe and durable alternative to approved autologous CAR T therapies in CAR T naïve patients, including manageable safety with no dose limiting toxicities (DLTs) or graft-vs-host disease (GvHD) and minimal Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), or Grade 3 cytokine release syndrome (CRS). In the Phase 1 ALPHA2 study, nearly all enrolled patients were able to receive therapy with the median time from enrollment to initiation of treatment of two days.

Allogene anticipates providing an update on the Phase 1 portion of the ALPHA and ALPHA2 trials toward the end of 2022. This update will include a few additional patients enrolled in ALPHA2 and will focus on longer-term follow up of patients previously treated in the ALPHA and ALPHA2 trials.

The EXPAND trial is expected to begin in 2022 and is planned to support registration of the lymphodepleting agent ALLO-647. This trial is intended to demonstrate the contribution of ALLO-647 to the lymphodepletion regimen.

BCMA Program

Allogene plans to explore its pivotal study approach and timing for its BCMA program by year end. In parallel, the Company intends to work within the framework afforded by its RMAT designation for ALLO-715 to facilitate FDA interactions and determine the best course forward.

Enrollment continues in the Phase 1 UNIVERSAL trial on ALLO-715 in r/r multiple myeloma (MM). Toward the end of 2022, Allogene intends to provide a clinical update that will focus on the longer-term follow up of patients in UNIVERSAL treated with a single dose of ALLO-715. Allogene has made the decision not to advance ALLO-715 in combination with nirogacestat from SpringWorks Therapeutics into dose expansion cohorts. There was no clear indication that the combination would meaningfully improve the benefit-risk profile of ALLO-715 as a monotherapy. Allogene’s Clinical Trial Collaboration Agreement with SpringWorks is expected to remain in effect until the data from the combination study are fully analyzed.

The IGNITE trial on TurboCAR candidate ALLO-605 continues to enroll patients in the dose escalation portion of this Phase 1 study.

Solid Tumor Programs

ALLO-316, which targets CD70, is the Company’s first AlloCAR T candidate for solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (RCC).

The FDA previously granted ALLO-316 Fast Track Designation (FTD) based on its potential to address the unmet need for patients with difficult to treat RCC who have failed standard therapies. Metastatic solid tumors have historically been a challenge regardless of treatment modality, and the five-year survival rate for patients with advanced kidney cancer is less than 15%, highlighting the need for innovation.

Corporate Highlights
CF1, Allogene’s commercial scale manufacturing facility located in Newark, California is fully operational and producing GMP material with the intent of supplying ALLO-501A for the planned pivotal study as well as other clinical trials. CF1 is projected to have the ability to manufacture approximately 20,000 ALLO-501A AlloCAR T doses annually at scale. CF1 recently earned a LEED Interior Design and Construction Gold designation from the U.S. Green Building Council (USGBS), a non-profit dedicated to sustainable building design and construction.

In July, Allogene announced the appointment of Stephen L. Mayo, Ph.D., a world-renowned expert in computational protein design, to the company’s Board of Directors. Dr. Mayo is the Bren Professor of Biology and Chemistry and Merkin Institute Professor at the California Institute of Technology in Pasadena, California. Dr. Mayo also serves on the Board of Directors of Merck & Co. and Sarepta Therapeutics, Inc.

Second Quarter Financial Results
•Research and development expenses were $57.2 million for the second quarter of 2022, which includes $13.0 million of non-cash stock-based compensation expense.
•General and administrative expenses were $19.5 million for the second quarter of 2022, which includes $9.9 million of non-cash stock-based compensation expense.
•Net loss for the second quarter of 2022 was $74.8 million, or $0.52 per share, including non-cash stock-based compensation expense of $22.9 million.
•The Company had $686 million in cash, cash equivalents, and investments as of June 30, 2022.

Updated 2022 Financial Guidance
While the Company anticipates spending to increase in the second half relative to the first half of 2022, it now expects full year GAAP Operating Expenses to be at the low end of the previous range of $360 million and $390 million. This includes estimated non-cash stock-based compensation expense of $90 million to $100 million and excluding any impact from potential business development activities. Cash burn for 2022 is now expected to be approximately $250 million.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (800) 715-9871 (U.S.) or 1 (646) 307-1963 (International). The conference ID number for the live call is 7832993. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On August 9, 2022 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported financial results for the second quarter ended June 30, 2022 and a midyear corporate update (Press release, Neoleukin Therapeutics, AUG 9, 2022, View Source [SID1234617917]).

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"Our focus at Neoleukin is the advancement of de novo proteins to solve important therapeutic challenges and address unmet medical needs," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "We are excited to be part of a revolutionary approach to creating therapeutic proteins that are not based on native sequences. Our first programs, including our lead product candidate, NL-201, were developed using sophisticated computational algorithms combined with directed evolution in the laboratory. We have now added machine learning and neural networks to our technological approach, enabling faster, more accurate development of increasingly complex proteins. Using these new processes, we have been able to add two new cytokine mimetics to our discovery pipeline this year."

"At Neoleukin, we are excited to be testing NL-201, which we believe is the first fully de novo protein in clinical trials," said Priti Patel, M.D., Chief Medical Officer. "We are pleased to have begun testing NL-201 in combination with pembrolizumab in mid-May of this year. We believe this is just one of many potential opportunities to harness the immune activating properties of NL-201 in novel combination regimens."

NL-201 Update

Neoleukin is conducting a clinical trial of intravenous NL-201 in patients with advanced solid tumors. The trial is evaluating two different schedules and multiple dose levels in order to determine a recommended Phase 2 dose and schedule. Intermediate dose levels have been added to both schedules, which has extended the timeline to reach the anticipated Phase 2 dose. Dose escalation continues in both schedules, and Neoleukin now anticipates disclosing interim data in 2023.

In April 2022, Neoleukin announced the presentation of preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, highlighting the potential for NL-201 to treat non-Hodgkin lymphoma as well as synergistic antitumor activity when NL-201 is combined with radiation therapy, including significant inhibition of tumor growth and increased survival in preclinical models.

In May 2022, Neoleukin announced treatment of the first patient in a combination arm evaluating the safety and efficacy of Neoleukin’s NL-201 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), as part of Neoleukin’s ongoing Phase 1 trial. Up to 132 patients will be enrolled in the combination arm of the study, which is being conducted through a clinical collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). The trial is assessing safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Research Updates

Technology: Neoleukin’s research team is actively engaged in the discovery of additional de novo cytokine mimetics as well as technological advances in order to accelerate the process from concept to proof of preclinical activity. Among these advances, the use of machine learning and neural networks have made it possible to design de novo proteins even when high-resolution structures have not yet been solved, using less compute resources and with a higher percentage of functional sequences. In addition to NL-201, Neoleukin has previously reported preclinical data for two de novo proteins: NL-CVX1, a decoy protein that mimics the human ACE2 binding site of the SARs-CoV2 spike protein and Neo-5171, an inhibitor of both IL-2 and IL-15 signaling.

Pipeline: Neoleukin is exploring an activator of T-regulatory cells for the treatment of inflammation and autoimmune diseases, a next generation IL-2/IL-15 agonist, and two additional undisclosed de novo cytokine mimetics for the treatment of cancer.

Summary of Financial Results

Cash Position: Cash, cash equivalents, and short-term investments totaled $116.5 million as of June 30, 2022, compared to $142.5 million as of December 31, 2021.

Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations through 2023.

R&D Expenses: Research and development expenses for the second quarter of 2022 increased to $11.0 million from $9.8 million for the second quarter of 2021. The increase was primarily due to increased clinical trial expenses related to NL-201.

G&A Expenses: General and administrative expenses for the second quarter of 2022 decreased to $4.9 million from $5.3 million for the second quarter of 2021. The decrease was primarily attributable to decreases in personnel-related and facility-related costs.

Net Loss: Net loss for the second quarter of 2022 was $15.7 million compared to a net loss of $15.1 million in the second quarter of 2021.

About NL-201

NL-201 is a de novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models.

Conference Call Information

Neoleukin will host a conference call today to provide a second quarter corporate update and review financials. Details are as follows:

The archived audio webcast with slides will be available on the Investor Relations section of the Neoleukin website approximately two hours after the event and will be available for replay for at least 30 days after the event.