On May 4, 2023 Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius" or the "Company"), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported that it has entered into definitive agreements with certain healthcare-focused and institutional investors for the purchase of an aggregate of 12,500,001 shares of its common stock and accompanying warrants to purchase up to an aggregate of 12,500,001 shares of its common stock, at a purchase price of $1.20 per share and accompanying warrant in a registered direct offering (Press release, Citius Pharmaceuticals, MAY 4, 2023, View Source [SID1234631067]). The closing of the offering is expected to occur on or about May 8, 2023, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $1.50 per share, will be exercisable six months from the date of issuance, and will expire five years from the date of issuance.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $15 million, before deducting the placement agent fees and other offering expenses payable by the Company. Citius currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-255005) filed with the Securities and Exchange Commission (SEC) and declared effective on April 16, 2021. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or emailing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On May 4, 2023 ABM Therapeutics, an innovative clinical-stage biopharmaceutical company, with an emphasis on developing drugs with high blood–brain barrier (BBB) penetration for CNS diseases including brain metastases, reported that the first patient was successfully dosed with ABM-168 in the United States (Press release, ABM Therapeutics, MAY 4, 2023, View Source [SID1234631066]).

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MEK (mitogen-activated protein kinase kinase), a key kinase of the MAPK pathway, is frequently activated in various cancers, including those with RAS mutations. These mutations are present in 20% of human cancers and 20-30% of NSCLC. ABM-168, a novel small molecule MEK inhibitor developed by ABM, exhibits good water solubility, high cell permeability and brain penetration. Preclinical studies have clearly demonstrated its anti-cancer properties, particularly in intracranial animal models.

"The dosing of the first patient with ABM-168 in the USA represents another important milestone for ABM. ABM-168 is a strategically important program for ABM’s development of combination therapies," Dr. Chen Chen, founder and CEO of ABM Therapeutics said. "Selective MEK inhibitors have the ability to inhibit tumor growth and induce cell death in RAF- and RAS-mutant cell lines. A MEK inhibitor in combination with a BRAF inhibitor has been demonstrated to be more effective and less toxic than a single BRAF inhibitor, which has become the standard of care for patients with BRAF-mutated melanoma. The combination of a MEK inhibitor with other anti-cancer drugs such as KRAS inhibitors and PD-1/PD-L1 antibodies is also explored. We look forward to the early clinical data which will help us to figure out the most effective combination for treating cancers, particularly those with high brain metastasis rates."

This phase I clinical trial in the US is a first-in-human multicenter, open-label, dose escalation and cohort expansion study, which is intended to assess the safety, tolerability, and pharmacokinetics of ABM-168 monotherapy in adult patients with advanced/metastatic solid tumors.

"We are very pleased to reach our study’s first patient dosed milestone at NEXT Oncology – Dallas, one of the clinical trial centers for this novel MEK inhibitor and collaborate with all study sites and investigators," said Dr. Zane Yang, CMO of ABM, "ABM will strive for ABM-168 clinical development to fulfill unmet medical needs and offer more therapeutic options. This makes a major step for our mission, passionate about developing drugs and improving patients’ quality of life."

As a clinical-stage biotechnology company, ABM Therapeutics has built a broad pipeline to construct a robust proprietary Brain-Penetrant Kinase Drug Discovery Platform (BPKddTM). Its first drug candidate ABM-1310, the next generation of BRAF inhibitor, is under clinical studies in both the US and China and has shown good safety profile including tolerability. ABM Therapeutics is in the process of Series B+ round financing, and looks forward to cooperating with international pharmaceutical companies, domestic and foreign biopharmaceutical companies, and securities and funds.

About ABM-168

ABM-168 is a novel small molecule MEK inhibitor with high water solubility, cell and brain permeability. It has demonstrated anti-cancer efficacy in vitro in multiple cancer cell lines and in vivo in multiple xenograft animal models. It was granted clearance of the Investigational New Drug (IND) application to proceed with the first-in-human clinical trial in October 2022 by the US FDA. More information about ABM’s ongoing ABM-168 trial is available at View Source (NCT 05831995) and on the company website at www.abmtx.com.

On May 5, 2023 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that Jacqueline Shea, Ph.D., President and CEO, will present at the 2023 RBC Capital Markets Global Healthcare Conference (Press release, Inovio, MAY 4, 2023, View Source [SID1234631065]).

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2023 RBC Capital Markets Global Healthcare Conference
Date: Wednesday, May 17, 2023
Time: 4:05 PM ET
Format: Fireside Chat

During the conference, Dr. Shea and members of INOVIO’s management team will conduct one-on-one meetings with registered investors.

A webcast of the presentation will be available on the INOVIO Investor Relations Events page at View Source A replay of the webcast will be available for 90 days after the date of the presentation.

On May 4, 2023 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Arvinas, MAY 4, 2023, View Source [SID1234631064]).

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"We made substantial progress throughout the first quarter across all areas of our early- and late-stage pipeline," said John Houston, Ph.D., president and chief executive officer at Arvinas. "Preliminary data from the ongoing Phase 1b combination study of vepdegestrant with palbociclib reinforce our confidence in the potential of vepdegestrant as an important treatment option in metastatic breast cancer. Together with Pfizer, we are on-track to initiate the safety lead-in to identify the dose of palbociclib for the planned Phase 3 trial with vepdegestrant and palbociclib. For bavdegalutamide, we are also on track to initiate a phase 3 trial in the second half of 2023, and we plan to share radiographic progression free survival data from the Phase 1/2 trial in the second half of 2023 as well. We look forward to progressing our clinical programs and new clinical candidates in the coming years."

Recent Developments and 1Q Business Highlights

Evaluated preliminary data (November 2022 cutoff) from Part C of the ongoing Phase 1b/2 ARV-471-mBC-101 study (ClinicalTrials.gov Identifier: NCT04072952).
Preliminary results from the Part C dose escalation (the Phase 1b combination of vepdegestrant + palbociclib 125 mg) demonstrate an observed clinical benefit rate (CBR; rate of confirmed complete response, confirmed partial response, or stable disease ≥24 weeks) of 60.7% (95% CI, 40.6 – 78.5) across all dose cohorts (17 of 28 CBR-evaluable patients; patients are CBR-evaluable if they received their first dose >24 weeks prior to the cut-off). Data are expected to be presented at a medical conference in the second half of 2023.
85.7% of the 28 CBR-evaluable patients had received CDK4/6 inhibitor therapy prior to study entry.
An increase in palbociclib exposure was observed relative to historical palbociclib pharmacokinetic data.
A similar overall safety profile was observed compared with that reported in previous palbociclib and endocrine therapy combination studies, except for a higher incidence of grade 3/4 neutropenia, which was managed by monitoring and dose modification per the palbociclib label. Patients were started on palbociclib 125 mg irrespective of dose reduction during prior CDK4/6 inhibitor therapy.
Gained alignment with the U.S. Food and Drug Administration on an approach for the planned 1L Phase 3 trial (VERITAC-3) with vepdegestrant (200 mg) in combination with palbociclib.
The safety lead-in is on-track to initiate in 2H 2023 and will start with a lead-in to evaluate the best starting dose of palbociclib (100 mg or 75 mg) in combination with vepdegestrant 200 mg once daily.
The objective is to select a dose of palbociclib (100 mg or 75 mg) that, when dosed with vepdegestrant 200 mg, results in a similar exposure and safety profile as palbociclib 125 mg in combination with aromatase inhibitors.
Continued enrollment in the VERITAC-2 Phase 3 2L+ clinical trial of vepdegestrant as a monotherapy for the treatment of patients with ER+/HER2- metastatic breast cancer (ClinicalTrials.gov Identifier: NCT05654623).
Continued enrollment in the TACTIVE-U study (vepdegestrant in combination with abemaciclib or ribociclib, (ClinicalTrials.gov Identifiers: NCTC05548127 and NCTC05573555), the TACTIVE-E study (vepdegestrant in combination with everolimus; ClinicalTrials.gov Identifier: NCT05501769), and the TACTIVE-N study (vepdegestrant as a monotherapy in the neoadjuvant setting; ClinicalTrials.gov Identifier: NCT05549505).
Announced the inclusion of vepdegestrant in the I-SPY-2 (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) trial sponsored by Quantum Leap. The I-SPY-2 Endocrine Optimization Platform (EOP) study (Identifier: NCT01042379) will include a vepdegestrant monotherapy arm and a vepdegestrant plus letrozole arm.
Presented vepdegestrant pre-clinical data at American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2023 demonstrating:
The potential utility of vepdegestrant as an endocrine therapy backbone for combination with other targeted agents in early and late-stage ER+/HER2- breast cancer.
The potential mechanisms of acquired resistance to vepdegestrant that may be associated with alterations within Receptor Tyrosine Kinase/MAPK signaling pathways rather than ER signaling or E3 ligase machinery.
Presented new in vivo and in vitro data at AACR (Free AACR Whitepaper) – Targeting RAS Special Conference demonstrating:
Arvinas’ KRAS G12D PROTAC degraders are potent, selective and led to tumor stasis in a mouse xenograft model with intermittent dosing.
Degradation of KRAS G12D provides an advantage vs. inhibition in vitro and in vivo.
Presented new ARV-766 preclinical data and compound structure at the AACR (Free AACR Whitepaper) annual meeting in April 2023.
Presented new preclinical data at the CHDI Foundation’s Annual Huntington’s Disease Therapeutics Conference showing that Arvinas PROTAC degraders potently and selectively degrade soluble mutant huntingtin (mHTT) in multiple cellular readouts, including rodent neurons, while sparing wild-type HTT.
Appointed Kelly Page as Senior Vice President, Global Head of Oncology Strategy and Program Leadership.
Announced that Timothy Shannon, M.D., our current Chairperson and a member of our board of directors since July 2013, will not be standing for re-election at the Annual Meeting.
"Tim’s support, guidance and unwavering dedication has been instrumental in our success since our founding 10 years ago," continued Dr. Houston. "We are grateful for his years of service on the Board, and on behalf of the entire Company, we thank Tim for his strategic insight, wisdom and integrity – all of which are ingrained in our work as we make progress towards improving the lives of patients with serious diseases."

Anticipated Upcoming Milestones and Expectations

Vepdegestrant (ARV-471)
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:

Initiate the safety lead-in to identify the dose of palbociclib for the planned Phase 3 trial with vepdegestrant + palbociclib as a first-line treatment in patients with ER+/HER2- locally advanced or metastatic breast cancer (2H 2023).
Submit and present additional data from the Phase 1b combination trial with palbociclib (ClinicalTrials.gov Identifier: NCT04072952) at a medical congress (2H 2023).
Initiate additional arms of the Phase 1b combination umbrella trial (TACTIVE-U: ClinicalTrials.gov Identifiers: NCTC05548127 and NCTC05573555) with other targeted therapies (2H 2023).
Complete enrollment for VERITAC-2 Phase 3 monotherapy trial (ClinicalTrials.gov Identifier: NCT05654623) in patients with metastatic breast cancer (2H 2024).
Androgen Receptor (AR) Franchise (Bavdegalutamide/ARV-110, ARV-766)

Share data from the Phase 1 dose escalation trial with ARV-766 in metastatic castration-resistant prostate cancer (mCRPC) (2Q 2023).
Submit and present additional data, including radiographic progression free survival, from the ongoing Phase 1/2 trial with bavdegalutamide at a medical congress (2H 2023).
Initiate a global Phase 3 trial with bavdegalutamide in mCRPC for patients with AR T878/H875 tumor mutations (2H 2023).
Complete enrollment in the Phase 1b combination study with bavdegalutamide plus abiraterone (2H 2023).
Initiate a Phase 1b or Phase 2 trial in patients who have not previously received novel hormonal agents (2H 2023).
Pipeline:

Submit two investigational new drug (IND)/clinical trial authorization (CTA) applications for the Company’s BCL6 (oncology) and LRRK2 (neuroscience) PROTAC protein degraders by year-end 2023.
Progress at least two additional PROTAC protein degrader programs into IND- or CTA-enabling studies by year-end 2023.
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, restricted cash and marketable securities as of March 31, 2023, is sufficient to fund planned operating expenses and capital expenditure requirements into 2026.

First Quarter Financial Results

Cash, Cash Equivalents, Restricted Cash and Marketable Securities Position: As of March 31, 2023, cash, cash equivalents, restricted cash and marketable securities were $1,129.0 million as compared with $1,210.8 million as of December 31, 2022. The decrease in cash, cash equivalents, restricted cash and marketable securities of $81.8 million for the three months ended March 31, 2023 was primarily related to cash used in operations of $87.9 million (net of $2.5 million received from two collaborators), loss on the sale of marketable securities of $0.9 million and the purchase of lab equipment and leasehold improvements of $1.1 million, partially offset by unrealized gains on marketable securities of $6.6 million and proceeds from the exercise of stock options of $1.5 million.

Research and Development Expenses: Research and development expenses were $95.3 million for the quarter ended March 31, 2023, as compared with $64.0 million for the quarter ended March 31, 2022. The increase in research and development expenses of $31.3 million for the quarter was primarily due to an increase in our continued investment in our platform and exploratory programs of $18.3 million, as well as an increase in expenses related to our AR program of $3.5 million, which includes bavdegalutamide and ARV-766, and our ER program of $9.5 million, which is net of the cost sharing of vepdegestrant (ARV-471) under the global Pfizer collaboration agreement to develop and commercialize vepdegestrant that was initiated in July 2021 (ARV-471 Collaboration Agreement).

General and Administrative Expenses: General and administrative expenses were $24.9 million for the quarter ended March 31, 2023, as compared with $20.2 million for the quarter ended March 31, 2022. The increase of $4.7 million was primarily due to an increase in personnel costs of $2.3 million and professional fees of $1.4 million.

Revenues: Revenues were $32.5 million for the quarter ended March 31, 2023, as compared with $26.5 million for the quarter ended March 31, 2022. Revenue is related to the ARV-471 Collaboration Agreement, the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017 and revenue related to our Oerth Bio joint venture which was initiated in July 2019. The increase in revenues of $6.0 million was primarily due to an increase in revenue from the ARV-471 Collaboration Agreement totaling $15.9 million, partially offset by a net decrease in revenue totaling $8.2 million due to extensions of the period of revenue recognition under both the Pfizer and Bayer collaboration agreements and a decrease of $1.2 million of previously constrained deferred revenue related to our Oerth Bio joint venture.

Income Tax Expense: Income tax benefit was $0.4 million for the quarter ended March 31, 2023, as compared with an income tax expense of $4.5 million for the quarter ended March 31, 2022. Current year tax benefit was driven by expected benefits from state net operating loss carryback claims. Prior year tax expense was driven by revenue recognized in 2022 for tax purposes from the ARV-471 Collaboration Agreement.

Loss from Equity Method Investment: Loss from equity method investment was $1.1 million for the quarter ended March 31, 2023, as compared with $2.3 million for the quarter ended March 31, 2022 due to decreased operating losses incurred by Oerth Bio.

Net Loss: Net loss was $81.9 million for the quarter ended March 31, 2023, as compared with $63.4 million for the quarter ended March 31, 2022. The increase in net loss for the quarter was primarily due to increased research and development expenses and general and administrative expenses, partially offset by decreased income tax expense and increased revenue.

About bavdegalutamide (ARV-110)
Bavdegalutamide (ARV-110) is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Bavdegalutamide is being developed as a potential treatment for men with mCRPC.

Bavdegalutamide has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Use of vepdegestrant in the ongoing and planned clinical trials will continue to monitor and evaluate patient safety and anti-tumor activity.

In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.

On May 4, 2023 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported financial results for the first quarter and provided a business update (Press release, Merus, MAY 4, 2023, View Source [SID1234631063]).

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"We were thrilled to share the robust interim clinical results for petosemtamab, our first in class bispecific antibody targeting EGFR and LGR5 in patients with previously treated head and neck squamous cell carcinoma at AACR (Free AACR Whitepaper)," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "We are advancing our petosemtamab program diligently toward a registration-directed study in head and neck cancer. We expect our strong cash position to continue to fund the company meaningfully beyond several near-term clinical milestones and program updates, and into the second half of 2025."

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics): Solid Tumors
Enrollment continues in dose expansion in the phase 1/2 trial, including in combination with Keytruda (pembrolizumab)

Petosemtamab is in clinical development in the expansion part of a phase 1/2 open-label, multicenter trial in advanced solid tumors, including previously treated head and neck squamous cell carcinoma (HNSCC). The Company also initiated a cohort investigating petosemtamab in combination with Keytruda in patients with untreated HNSCC, designed to evaluate safety and clinical activity in this population.

In April, Merus provided an interim clinical update at the AACR (Free AACR Whitepaper) Annual Meeting 2023. As of the February 1, 2023 data cutoff date, 49 previously treated HNSCC patients (pts) were treated with petosemtamab at the recommended phase 2 dose of 1500 mg intravenous every two weeks. Patients had experienced a median of 2 (range 1-4) prior lines of systemic therapy including PD-(L)1 inhibitor in 96% of pts, chemotherapy in 94% and platinum-based chemotherapy in 92% of pts; 2 pts received prior cetuximab. 43 pts were evaluable for efficacy, receiving ≥2 treatment cycles (≥8 weeks) with ≥1 post-baseline tumor assessment or experiencing early progressive disease. The overall response rate was 37.2% (16/43; 95% CI 23%-53.3%) by RECIST 1.1. per investigator assessment, including 15 confirmed partial responses and 1 confirmed complete response (ongoing after 20 months). Median duration of response was 6.0 months (95% CI 3.7-NC), with 10 of 16 (62.5%) responders ongoing at the time of the data cutoff. Median progression free survival was 5.3 months (95% CI 3.7-6.8); with 29 of 43 pts progressing and 14 of 43 pts censored. Median overall survival was 11.5 months (95% CI 7.2-20.6); with 29 of 49 pts still alive at the data cutoff date. Petosemtamab continued to demonstrate a manageable safety profile.

Merus met with the U.S. Food and Drug Administration (FDA) in an end-of-phase meeting to discuss interim results from the previously treated HNSCC cohort of the petosemtamab phase 1/2 trial. The FDA recognized recurrent or metastatic HNSCC represents an area of unmet medical need, and provided clear recommendations for the path to potential registration.

Based on the strong clinical data and discussions with the FDA, Merus believes a randomized clinical trial in previously treated (2L/3L) or untreated (front-line) HNSCC may support a possible registration. Additionally, Merus believes a randomized registration trial in HNSCC with an overall response rate endpoint could potentially support accelerated approval and the overall survival results from the same study could potentially verify its clinical benefit to support regular approval. The Company plans to continue to acquire data to confirm a suitable dose for future randomized clinical trials. Merus plans to provide an update in Q3 2023 on the potential registrational path for this program.

Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3 Biclonics): NRG1+ cancer and other solid tumors
Enrollment continues in the eNRGy trial of Zeno monotherapy in NRG1+ cancer; and a phase 2 trial of Zeno in combination with androgen deprivation therapy (ADT) in castration resistant prostate cancer (CRPC), and in combination with afatinib in NRG1+ non-small cell lung cancer (NSCLC)

Merus plans to provide an update on the potential registrational path and timeline in NRG1+ cancer in the first half of 2023 and a clinical update on Zeno in NRG1+ cancer at a major medical conference in 2023.

Further, Merus is evaluating Zeno in combination with an ADT (enzalutamide or abiraterone) in men with CRPC, irrespective of NRG1+ status. Merus plans to provide initial clinical data on Zeno in CRPC in the second half of 2023.

Merus is also evaluating Zeno in combination with afatinib in patients with NRG1+ NSCLC.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors
Enrollment continues in the expansion cohorts in the phase 1/2 trial; clinical update planned for 2H23

MCLA-129 is in clinical development in a phase 1/2, open-label clinical trial evaluating MCLA-129 monotherapy in patients with EGFR ex20 NSCLC, MET ex14 NSCLC, and in HNSCC, as well as MCLA-129 in combination with Tagrisso (osimertinib), a third generation EGFR TKI, in patients with treatment-naïve EGFR mutant (m) NSCLC and in patients with EGFRm NSCLC that have progressed on Tagrisso.

In April, Merus provided a pre-clinical presentation of MCLA-129 in comparison with amivantamab at the AACR (Free AACR Whitepaper) Annual Meeting 2023. The Company plans to provide an initial clinical data update from the expansion cohorts, and a further clinical development strategy update in the second half of 2023.

MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to develop MCLA-129 and potentially commercialize exclusively in China, while Merus retains global rights outside of China.

MCLA-145 (CD137 x PD-L1 Biclonics): Solid Tumors
Enrollment continues in the phase 1 trial including in combination with Keytruda (pembrolizumab), a PD-1 inhibitor

MCLA-145 is in clinical development in a global, phase 1, open-label, clinical trial evaluating MCLA-145 in patients with solid tumors. The trial consists of a dose escalation phase, followed by a dose expansion phase. Merus is also evaluating the combination of MCLA-145 with Keytruda, with enrollment ongoing.

Collaborations

Incyte Corporation
Since 2017, Merus has been working together with Incyte Corporation (Incyte) under a global collaboration and license agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics technology platform. The agreement grants Incyte certain exclusive rights for up to ten bispecific and monospecific antibody programs. The collaboration is progressing, with multiple programs in various stages of preclinical and clinical development. For each program under the collaboration, Merus receives reimbursement for research activities and is eligible to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved. Further, Incyte announced, in 2023, that INCA32459, a novel Lag3xPD-1 bispecific antibody developed through the collaboration is currently being evaluated in clinical studies. In January 2023, Merus achieved a milestone payment of $2.5 million related to this program.

Loxo Oncology at Lilly
In January 2021, Merus and Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (Lilly), announced a research collaboration and exclusive license agreement to develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies utilizing Merus’ Biclonics platform and proprietary CD3 panel along with the scientific and rational drug design expertise of Loxo Oncology at Lilly. The collaboration is progressing with multiple active research programs underway.

Cash Runway, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into second half 2025
As of March 31, 2023, Merus had $287.3 million cash, cash equivalents and marketable securities. Based on the Company’s current operating plan, the existing cash, cash equivalents and marketable securities are expected to fund Merus’ operations into second half 2025.

Annual General Meeting and Board of Directors
The Company’s annual general meeting of shareholders is planned to be held on May 26, 2023.

First Quarter 2023 Financial Results
We ended the first quarter with cash, cash equivalents and marketable securities of $287.3 million compared to $326.7 million at December 31, 2022. The decrease was primarily the result of cash used to fund the operations.
Collaboration revenue for the three months ended March 31, 2023 increased by $1.8 million as compared to the three months ended March 31, 2022, primarily as a result of an increase from an Incyte milestone met of $2.5M partially offset by lower cost reimbursement revenue.

Research and development expense for the three months ended March 31, 2023 increased by $7.9 million as compared to the three months ended March 31, 2022, primarily as a result of an increase in clinical and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the three months ended March 31, 2023 increased by $3.6 million as compared to the three months ended March 31, 2022, primarily as a result of increases in consulting costs of $2.3 million, facilities costs of $0.8 million and personnel related expenses including stock-based compensation.

Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.