On August 8, 2022 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the quarter ended June 30, 2022, its recent business highlights, and a preview of anticipated select milestones (Press release, Sutro Biopharma, AUG 8, 2022, View Source [SID1234617848]).

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"This quarter, Sutro continued to execute on the promise of our platform, as marked by the recently announced collaboration with Astellas covering research and development of immunostimulatory ADCs, or iADCs—a novel modality with the potential to turn cold tumors hot," said Bill Newell, Sutro’s Chief Executive Officer. "Additionally, we are pleased to see Merck dosing patients in its Phase 1 study as part of our cytokine derivative collaboration. This represents the sixth clinical-stage product candidate enabled by Sutro’s platform. Looking ahead, we are optimistic about the potential of our pipeline of ADCs; this includes STRO-002 for patients with platinum-resistant ovarian cancer, as well as our newly unveiled STRO-003, an optimized ROR1 ADC, which we anticipate will be our next proprietary product candidate to move into clinical studies."

Recent Business Highlights and Anticipated Select Milestones

STRO-002, FolRα-Targeting ADC: STRO-002 is being studied in the clinic, in both the U.S. and Europe, for patients with ovarian and endometrial cancers.

The Phase 1 dose-expansion cohort for patients with advanced ovarian cancer has completed enrollment and is ongoing. Sutro expects to report additional data on efficacy, safety, and durability from the dose-expansion cohort, together with the design of a potential registrational study, in the second half of 2022.
Discussions with the FDA on a potential registrational study for patients with advanced ovarian cancer were held mid-year 2022, in which the agency signaled that an accelerated approval pathway could be available for STRO-002 in a platinum-resistant ovarian cancer patient population.
Additional ongoing clinical studies for STRO-002 include a combination study with bevacizumab for patients with advanced ovarian cancer and a dose-expansion study for patients with endometrial cancer.
STRO-001, CD74-Targeting ADC: The Phase 1 study for patients with B-cell malignancies, including patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM), continues in dose escalation.

Dose escalation is ongoing to achieve a recommended Phase 2 dose (RP2D), with the last reported doses of 5.0 mg/kg in the MM cohort and 5.0 mg/kg in the NHL cohort.
Sutro is opening additional sites for STRO-001 outside of the U.S. and Greater China, to increase the rate of enrollment; and Sutro’s partner BioNova Pharma (BioNova) is advancing clinical development of BN301 (STRO-001) for patients with hematological malignancies in Greater China.
Additional Pipeline Programs: A Sutro Research Forum highlighted STRO-003 and its emerging research portfolio.

STRO-003 is an optimally designed ADC targeting ROR1, with precisely positioned β-Glucuronidase-cleavable linkers, attached to eight next-generation exatecan warheads, which inhibit topoisomerase-1 resulting in DNA disruption.
Patient-derived xenograft models (PDX) have shown potent cell killing by STRO-003 in low antigen expressing tumors; and STRO-003 has shown encouraging tolerability in preclinical rodent and non-human primate studies.
Sutro provided details on its product and process design, which enables its emerging portfolio including novel therapeutic modalities—for example, a single antibody which was conjugated to be site-specific, with two different payloads with synergistic mechanisms.
Collaboration Updates: Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has generated from collaborators an aggregate of approximately $583 million, which includes payments and equity investments through June 30, 2022, in addition to the $90 million upfront payment from Astellas received in July 2022.

Sutro entered into a collaboration with Astellas on the discovery and development of iADCs for three targets, including an upfront payment to Sutro of $90 million, which was received in July 2022, and $422.5 million in potential milestones per product candidate. Sutro will also receive financial support for its research efforts and has an option to co-develop and co-commercialize product candidates in the U.S.
A $10 million milestone payment from Merck was triggered in July 2022 upon the first patient dosed in a Phase 1 study of MK-1484, a selective IL-2 agonist, under the existing cytokine derivative collaboration.
Sutro is manufacturing initial drug supply for the clinical development of Merck’s MK-1484, currently in a Phase 1 study; clinical trial materials for Bristol Myers Squibb’s (BMS) CC-99712, a BCMA-targeting ADC for treatment of multiple myeloma, in Phase 1 studies; and clinical trial materials for M1231, a MUC1-EGFR-targeting bispecific ADC, for Merck KGaA, Darmstadt, Germany, known as EMD Serono in the U.S. and Canada (EMD Serono), in Phase 1 studies.
Sutro supplies cell-free extract to Vaxcyte for the manufacture of clinical trial materials for VAX-24, which is designed to prevent invasive pneumococcal disease. Vaxcyte announced in July 2022 that it had completed enrollment of the Phase 1/2 clinical proof-of-concept study of VAX-24. Sutro is eligible to receive four percent (4%) royalties on worldwide net sales of VAX-24 and any licensed vaccine candidates.
BioNova announced in July 2022 that it had submitted its IND for BN301 (STRO-001) to the National Medical Products Administration for the treatment of hematologic malignancies. Sutro is providing clinical drug supply to BioNova for clinical studies in Greater China.
Sutro is currently supporting Tasly for initiation of clinical development activities and IND filing in Greater China for STRO-002 and will provide initial clinical drug supply.
Second Quarter 2022 Financial Highlights

Cash, Cash Equivalents and Marketable Securities
As of June 30, 2022, Sutro had cash, cash equivalents and marketable securities of $191.6 million, as compared to $192.1 million as of March 31, 2022, which, together with the $90 million upfront payment received from Astellas in July 2022, provides a projected cash runway into the first half of 2024, based on current business plans and assumptions. The above balances do not include the value associated with Sutro’s holdings of Vaxcyte common stock.

Unrealized Loss from Decrease in Value of Vaxcyte Common Stock
As of June 30, 2022, Sutro held approximately 1.6 million shares of Vaxcyte common stock, with a fair value of $34.0 million. The non-operating, unrealized loss of $3.7 million in the second quarter of 2022 was due to the decrease since March 31, 2022 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’s statements of operations.

Revenue
Revenue was $28.1 million for the quarter ended June 30, 2022, as compared to $28.0 million for the same period in 2021, related principally to recognition of the upfront payment from Tasly in the second quarter of 2022 and the Merck, BMS, and EMD Serono collaborations in both years. Future collaboration revenue from Astellas, Tasly, Merck, BMS, and EMD Serono, and from any additional collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other collaboration agreement payments.

Operating Expenses
Total operating expenses for the quarter ended June 30, 2022 were $47.5 million, as compared to $37.9 million for the same period in 2021. The second quarter of 2022 includes non-cash expenses for stock-based compensation of $6.7 million and depreciation and amortization of $1.4 million, as compared to $5.9 million and $1.1 million, respectively, in the comparable 2021 period. Total operating expenses for the quarter ended June 30, 2022 were comprised of research and development expenses of $32.3 million and general and administrative expenses of $15.1 million, which are expected to increase in 2022 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.

On August 8, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported financial results and provided business highlights for the second quarter and first six months of 2022 (Press release, Prothena, AUG 8, 2022, View Source [SID1234617847]).

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"We are closing the first half of 2022 from a position of strength, with multiple clinical programs advancing and a solid cash position supporting a robust set of milestones anticipated in 2022 and beyond. We are grateful for the opportunity to quickly progress the development of PRX012, a next-generation anti-Aβ antibody, under FDA’s Fast Track designation, further reinforcing our commitment to Alzheimer’s disease patients and their families," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "We believe our anticipated progress in the second half of the year will continue to validate our biology-directed R&D strategy, with antibodies that have been engineered to target pathogenic proteins in a manner we believe will be most impactful for the treatment of disease. We expect to achieve multiple milestones, including topline Phase 1 data for PRX005, the initiation of a Phase 1 multiple ascending dose study of PRX012 and the continued advancement of the Phase 2 study of PRX004 by Novo Nordisk. Additionally, we remain focused on our confirmatory Phase 3 AFFIRM-AL study of birtamimab, the first potential therapy to show survival benefit in Mayo Stage IV patients with AL amyloidosis."

Second Quarter and Recent Business Highlights and Upcoming Milestones

Neurodegenerative Diseases Portfolio

Alzheimer’s Disease (AD)

PRX012, a potential best-in-class, next-generation treatment for AD, is an investigational monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency supporting subcutaneous administration

In April, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for PRX012 for the treatment of AD
Phase 1 multiple ascending dose (MAD) study initiation expected by year-end 2022
Topline data from Phase 1 study expected in 2023
PRX005, a potential best-in-class treatment for AD, is an investigational antibody that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE), and other tauopathies. PRX005 is part of the global neuroscience research and development collaboration with Bristol Myers Squibb

Topline data from Phase 1 study expected in 2022
PRX123, a potential first-in-class dual Aβ/tau vaccine treatment and prevention therapy for AD, is a dual-target vaccine targeting key epitopes within the Aβ and tau proteins to promote amyloid clearance and blockade of pathogenic tau

IND filing expected in 2023
Parkinson’s Disease (PD)

Prasinezumab, a potential first-in-class treatment for PD, is a humanized monoclonal antibody designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of the worldwide collaboration with Roche

Phase 2b PADOVA study results expected in 2024
Rare Peripheral Amyloid Diseases Portfolio

AL Amyloidosis

Birtamimab, a potential best-in-class amyloid depleter treatment for AL amyloidosis, is an investigational humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure

Abstract accepted for poster presentation on Monday September 5, 2022 at the XVIII International Symposium on Amyloidosis (ISA) titled: Birtamimab in Patients with Mayo Stage IV AL Amyloidosis: Rationale for Confirmatory AFFIRM-AL Phase 3 Study (Poster P040)
Confirmatory Phase 3 AFFIRM-AL study results expected in 2024
ATTR Amyloidosis

NNC6019 (previously PRX004), a potential first-in-class treatment for ATTR amyloidosis, is a humanized monoclonal antibody designed to deplete the pathogenic, non-native forms of the transthyretin (TTR) protein, that is being developed by Novo Nordisk for the treatment of ATTR cardiomyopathy

Phase 2 trial of NNC6019 in patients with ATTR cardiomyopathy is being conducted by Novo Nordisk (NCT05442047)
Second Quarter and First Six Months of 2022 Financial Results

For the second quarter and first six months of 2022, Prothena reported a net loss of $41.2 million and $77.5 million, as compared to a net income of $27.6 million and a net loss of $9.1 million for the second quarter and first six months of 2021. Net loss per share for the second quarter of 2022 and first six months of 2022 was $0.88, and $1.66, respectively, as compared to net income per share on a diluted basis of $0.58 and net loss per share of $0.21 for the second quarter and first six months of 2021, respectively.

Prothena reported total revenue of $1.3 million and $2.5 million for the second quarter and first six months of 2022, respectively, primarily from collaboration revenue from BMS. As compared to total revenue of $60.1 million and $60.2 million for the second quarter and first six months of 2021, from collaboration and license revenue from Roche.

Research and development (R&D) expenses totaled $31.6 million and $58.8 million for the second quarter and first six months of 2022, respectively, as compared to $21.1 million and $42.2 million for the second quarter and first six months of 2021, respectively. The increase in R&D expense for the second quarter and first six months of 2022 compared to the same periods in the prior year was primarily due to higher personnel related expenses, higher clinical trial expenses primarily related to the PRX012 and birtamimab programs, higher manufacturing costs primarily related to the birtamimab, PRX019 and PRX123 programs, and higher other R&D expense; offset in part by lower collaboration expenses related to the prasinezumab program with Roche as a result of the cost share opt-out exercised in May 2021 and lower manufacturing expenses related to the NNC6019/PRX004 and PRX005 programs. R&D expenses included non-cash share-based compensation expense of $3.8 million and $7.1 million for the second quarter and first six months of 2022, respectively, as compared to $2.2 million and $4.2 million for the second quarter and first six months of 2021, respectively.

General and administrative (G&A) expenses totaled $13.0 million and $24.8 million for the second quarter and first six months of 2022, respectively, as compared to $11.0 million and $22.2 million for the second quarter and first six months of 2021, respectively. The increase in G&A expenses for the second quarter and first six months of 2022 compared to the same periods in the prior year was primarily related to higher personnel related expenses and higher consulting expenses; offset in part by lower legal expenses. G&A expenses included non-cash share-based compensation expense of $4.5 million and $8.8 million for the second quarter and first six months of 2022, respectively, as compared to $3.3 million and $7.5 million for the second quarter and first six months of 2021, respectively.

Total non-cash share-based compensation expense was $8.3 million and $15.9 million for the second quarter and first six months of 2022, respectively, as compared to $5.5 million and $11.7 million for the second quarter and first six months of 2021, respectively.

As of June 30, 2022, Prothena had $510.1 million in cash, cash equivalents and restricted cash, and no debt.

As of July 29, 2022, Prothena had approximately 46.9 million ordinary shares outstanding.

2022 Financial Guidance

The Company continues to expect the full year 2022 net cash used in operating and investing activities to be $120 to $132 million, which includes an expected $40 million clinical milestone payment from Novo Nordisk and expects to end the year with approximately $454 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2022 net cash used in operating and investing activities is primarily driven by an estimated net loss of $154 to $170 million, which includes an estimated $32 million of non-cash share-based compensation expense.

On August 8, 2022 PDX Pharmaceuticals reported Data on the ARAC (Antigen Release Agent and Checkpoint Inhibitor) technology has been published in Nature Communications (impact factor 17.7) (Press release, PDX Pharmaceuticals, AUG 8, 2022, View Source [SID1234617846]). ARAC is built upon our patented nanoparticle platform capable of co-delivering multiple therapeutic agents, while keeping a small size – similar to the size of a virus – suitable for infusion and tumor accumulation. ARAC co-delivers a polo-like kinase 1 (PLK1) inhibitor and a PD-L1 antibody to generate cancer specific immune responses. In a metastatic lung tumor model, ARAC reduced the effective doses of free drugs (PLK1 inhibitor and PD-L1 antibody) by 5-fold and the effect was mediated by CD8+ T cells. Importantly, ARAC was also effective in lung tumors that were not responsive to the gold standard immunotherapies, which suggests that ARAC may overcome the clinical limitation of low response rates to immunotherapies.

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PDX Pharma in collaboration OHSU is further optimizing the second gen ARAC-02, which is ARAC loaded with immune-stimulant CpG to increase the CD8+ T cell repertoire. These three agents were carefully selected based on their roles in cancer and immune pathways. ARAC-02 can attack tumors directly, train the immune system to attack tumors, and prevent tumors from avoiding the immune system’s attack. The project received a perfect score from the NIH review panel and is now funded by a fast track SBIR award from the National Cancer Institute. We are seeking private investment for IND enabling studies of ARAC-02 for lung cancer treatment as well as funding from the Department of Defense’s Breast Cancer Research Program (BCRP) for treating triple negative breast cancer.

On August 8, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a global collaboration that provides GSK plc (LSE/NYSE: GSK) an exclusive option to co-develop and commercialize XMT-2056, an Immunosynthen ADC that targets a novel epitope of HER2 (Press release, Mersana Therapeutics, AUG 8, 2022, View Source [SID1234617842]). XMT-2056 is designed to activate the innate immune system through STING signaling in both tumor-resident immune cells and in tumor cells.

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"GSK brings highly complementary development and commercial capabilities, a wealth of immuno-oncology experience, a deep knowledge of the STING pathway and a shared vision for XMT-2056’s broad potential," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "We believe this agreement solidifies Mersana’s position as a partner of choice during this momentous period in the ADC space and serves as validation for our Immunosynthen platform, which takes ADCs beyond the cytotoxic realm by enabling a targeted stimulation of the innate immune system. Additionally, the agreement structure demonstrates our ability to generate meaningful non-dilutive capital upfront to support the development of our innovative candidates while also providing the potential for meaningful downstream economics."

In preclinical models, XMT-2056 demonstrated robust anti-tumor activity as a monotherapy in both HER2-high and HER2-low expressing models, and enhanced efficacy has been shown when used in combination with multiple approved agents, including trastuzumab, pertuzumab, anti-PD-1, or trastuzumab deruxtecan. Preclinical data also suggest that XMT-2056 has the potential to enable immunological memory for prolonged anti-tumor activity.

Mersana expects to initiate a Phase 1 clinical trial of XMT-2056 to investigate its potential in a range of HER2-expressing tumors such as breast, gastric and non-small-cell lung cancers. The U.S. Food and Drug Administration recently granted an orphan drug designation to XMT-2056 for the treatment of gastric cancer.

John Lepore, Senior Vice President of Research, GSK, said, "At GSK, our goal is to bring transformational treatment options to patients with cancer, so we are pleased to be able to enter into this agreement for XMT-2056. Its preclinical data demonstrate how it might work to harness the immune system by activating the STING pathway, and its differentiated mechanism of action offers the potential for additional clinical benefit in patients with HER2-expressing tumors."

Under the terms of the agreement, Mersana will receive an upfront option purchase fee of $100 million. Mersana also is eligible to receive up to $1.36 billion in the form of an option exercise payment and development, regulatory and commercial milestone payments if GSK exercises its option.

Mersana has retained options to profit-share and to co-promote in the United States. If it exercises its profit-share option, Mersana will be eligible to receive tiered royalties on net sales outside of the United States. If Mersana does not elect to profit-share, it is eligible to receive double-digit tiered royalties on global net sales.

If GSK opts into the license, the effectiveness of the license grant may be subject to customary closing conditions, including review under the Hart-Scott-Rodino Act.

Conference Call Reminder
Mersana will host a conference call today at 4:30 p.m. ET to discuss this collaboration, other business updates and its financial results for the second quarter of 2022. To access the call, please dial 646-307-1963 (domestic) or 800-715-9871 (international) and provide the Conference ID 4656534. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for at least 90 days.

On August 8, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the second quarter ended June 30, 2022 (Press release, Corvus Pharmaceuticals, AUG 8, 2022, View Source [SID1234617841]).

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"We continue to see encouraging clinical data from the Phase 1 clinical trial of CPI-818 in T cell lymphomas, both in its effects on tumor growth and its effects on normal T cells. Based on this data, along with new preclinical models that demonstrate its potential in autoimmune and allergic diseases, we have decided to focus our efforts on advancing the development of CPI-818," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "The intensification of efforts on this program brings other advantages – we expect that we can generate additional clinical data in the near-term, we believe CPI-818 is the most advanced program targeting ITK inhibition and our team has expertise developing and launching an analogous target in BTK inhibition with Ibrutinib."

"We will continue to advance ciforadenant, our adenosine 2a inhibitor, which also has the potential to deliver near-term clinical data from our planned Phase 2 clinical trial. We remain excited about mupadolimab, our B cell activating anti-CD73 antibody, which will now be paused in development but remains ready to enter a randomized Phase 2 clinical trial in front line lung cancer. Altogether, our portfolio prioritization extends our cash runway and gives us the potential to deliver near-term clinical data for CPI-818, which is uniquely positioned to address a broad range of indications in cancer, autoimmunity and allergy."

Business Update and Strategy

CPI-818 (selective ITK inhibitor)
Corvus and its partner in China, Angel Pharmaceuticals, are enrolling patients with relapsed T cell lymphomas (TCL) in Phase 1/1b trial evaluating single agent therapy with CPI-818. Angel Pharmaceuticals is responsible for all expenses related to conducting the clinical trial in China.

Monitoring of immune modulation of normal T cells as well as safety and anti-tumor activity are being assessed in the clinical trial, with additional data from the trial expected later this year.
As recently reported, the Company has identified 200 mg orally twice per day as the optimum dosing regimen for CPI-818. This dose regimen has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of Th2 cells. Corvus and Angel are now enrolling additional patients with TCL in a 200 mg cohort of the clinical trial.
As of July 22, 2022 in the 200 mg cohort, 12 patients have been enrolled and 8 are evaluable for response. There has been 1 complete response (CR) lasting 25 months; 1 nodal CR lasting 16 months; 1 partial response (PR) ongoing at 2 months follow up. Five patients had stable disease (SD), 2 of the patients with SD have been on treatment for approximately 12 weeks and continue on study. Two additional patients are on treatment and have not yet had their disease monitoring assessments. An additional patient in the 600 mg cohort also had a PR.
As of July 22, 2022, analysis of blood in 4 of 4 patents treated in the 200 mg cohort showed increases in Th1 cells compared to baseline and increases in terminally differentiated T effector memory cells; these are T cells that are antigen primed and capable of destroying tumor cells. Tumor biopsy from 1 patient taken during response demonstrated an increase in these cells in the tumor.
Three of three patients in the 200 mg cohort with high baseline, pretreatment eosinophil counts demonstrated reductions in circulating eosinophils during treatment with CPI-818. Eosinophils are white blood cells that play a key role in allergic and autoimmune diseases and they are often elevated in patients with TCL.
As of July 22, 2022, no dose limiting toxicities (DLTs) have been observed at doses up to 600 mg orally twice per day.
Corvus is also developing CPI-818 for autoimmune and allergic diseases and is preparing to initiate clinical trials for certain autoimmune diseases.

CPI-818 has demonstrated activity in various animal models of autoimmunity including models of systemic lupus erythematosus, psoriasis, inflammatory bowel disease and graft versus host disease. Some of this research was presented at the annual meetings of the American Society of Hematology (ASH) (Free ASH Whitepaper) in 2020 and 2021.
In July, the Company appointed James Rosenbaum, M.D. as Senior Vice President, Research, with an initial focus on leading the Company’s development efforts for CPI-818 in autoimmune and allergic diseases. Dr. Rosenbaum previously served as Professor of Inflammatory Diseases and Chair, Division of Arthritis & Rheumatic Diseases, at Oregon Health & Science University and has authored over 600 publications.
Ciforadenant (adenosine 2a receptor antagonist)

The Company plans to collaborate with the Kidney Cancer Clinical Trials Consortium to initiate an open-label Phase 2 clinical trial evaluating ciforadenant as a first-line therapy for metastatic RCC in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The clinical trial, which is anticipated to be initiated in the third quarter 2022, will enroll up to 60 patients and is intended to evaluate the potential for ciforadenant to generate increased complete responses and deep responses in the front-line setting.
The Kidney Cancer Clinical Trials Consortium is comprised of a group of leading cancer centers in the United States led by investigators at MD Anderson. The trial design is based on Corvus’ preclinical research published in 2018 in Cancer Immunology Research that demonstrated impressive antitumor control and cures in several animal models using ciforadenant in combination with anti-CTLA4 and anti-PD1.
Mupadolimab (anti-CD73)

The Company has completed enrollment in its two Phase 1/1b clinical trial expansion cohorts of patients with (1) head and neck cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy and (2) relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy.
Based on the results to-date, the Company believes this program is ready to advance into a randomized Phase 2 clinical trial evaluating mupadolimab in combination with pembrolizumab and chemotherapy as a front-line therapy for the treatment of patients with NSCLC. However, the Company is delaying the initiation of this clinical trial in order to prioritize the development of CPI-818 and to conserve capital.
Angel Pharmaceuticals plans to continue the development of mupadolimab in China. The CDE (Center for Drug Evaluation) in China has accepted for filing the IND to initiate a Phase 1 trial with mupadolimab alone and together with pembrolizumab in patients with advanced NSCLC and head and neck cancer.
Financial Results
As of June 30, 2022, Corvus had cash, cash equivalents and marketable securities totaling $56.7 million. This compared to cash, cash equivalents and marketable securities of $69.5 million as of December 31, 2021. Corvus expects full year 2022 net cash used in operating activities to be between $27 million and $29 million, resulting in a projected cash balance of between $40.5 million and $42.5 million as of December 31, 2022. Based on its current plans, the Company expects its cash to fund operations into early 2024.

Research and development expenses for the three months ended June 30, 2022 totaled $4.9 million compared to $9.1 million for the same period in 2021. The decrease of $4.2 million was primarily due to reduced clinical trial costs associated with the mupadolimab Phase 3 trial in COVID-19 patients.

The net loss for the three months ended June 30, 2022 was $8.4 million compared to a net loss of $11.8 million for the same period in 2021. Total stock compensation expense for the three months ended June 30, 2022 was $0.7 million compared to $1.2 million for the same period in 2021 and the non-cash loss from the Company’s equity method investment in Angel Pharmaceuticals was $1.6 million for the three months ended June 30, 2022 compared to $0.5 million in the same period in 2021.

Conference Call Details
Corvus will host a conference call and webcast today, Monday, August 8, 2022, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2022 financial results. The conference call can be accessed by dialing 1-844-825-9789 (toll-free domestic) or 1-412-317-5180 (international) and using the conference ID 10169996. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.