On May 9, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has received an Issue Notification from the United States Patent and Trademark Office (USPTO) for U.S. Patent number 11,980,634 titled, "Method of Reconstituting Liposomal Annamycin" (the ‘634 patent’) to be issued on May 14, 2024 to Moleculin and The University of Texas System Board of Regents (Press release, Moleculin, MAY 9, 2024, View Source [SID1234643006]).

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When issued, the patent will provide claims to liposomal Annamycin suspension compositions with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill regulatory requirements for FDA approval. Moleculin’s novel candidate for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets) uses a unique lipid-based delivery technology. In addition to the expected ‘634 patent and recently issued ‘118 patent, Moleculin has additional patent applications related to Annamycin pending in the U.S. and in major jurisdictions worldwide.

Walter Klemp, CEO and Chairman of Moleculin, stated, "We remain committed to establishing a robust patent estate for Annamycin and driving its development forward. In addition to our recently announced composition of matter patent for Annamycin, we believe we are well positioned for the potential partnering discussions which we expect to have in the near future. The issuance of this patent further underscores the importance and proprietary nature of the innovation that makes this next generation anthracycline possible and bolsters our confidence in its potential to address a number of high-value indications where there remains unmet medical need."

Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic (unlike currently prescribed anthracyclines) and has shown to be non-cardiotoxic in the 82 subjects treated in multiple studies in the U.S. and in Europe. Furthermore, Annamycin has recently shown in Moleculin’s European clinical study for the treatment of AML using Annamycin in combination with Cytarabine (MB-106) a preliminary 60% composite complete response (CRc) rate in 2nd line subjects (N=10) and an overall interim CRc of 39% in all subjects (N=18), regardless of the prior number of therapies, in the European trial. Durability of the CRc’s is developing. One subject has surpassed the one-year mark with a durable complete response. Recruitment in MB-106 has ended for 2nd line subjects while recruitment for 1st line and 3rd line subjects continue. Annamycin is currently in development for the treatment for AML and STS lung mets, and the Company believes the drug may have the potential to treat additional indications.

Disclosure
MD Anderson has an institutional conflict of interest with Moleculin, and this relationship is managed according to an MD Anderson Institutional Conflict of Interest Management and Monitoring Plan.

On May 9, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, ALX Oncology, MAY 9, 2024, View Source [SID1234643034]).

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"We entered the quarter with a great deal of momentum having achieved a key validating development milestone for our platform asset evorpacept in Q4 2023 by reporting positive results in a prespecified randomized interim analysis of ASPEN-06’s Phase 2 clinical trial in advanced HER2-positive gastric/GEJ cancer, becoming the first CD47 blocker to demonstrate anti-tumor activity in a global randomized study in solid tumors," said Jason Lettmann, Chief Executive Officer of ALX Oncology. "On the heels of this outstanding accomplishment, our first quarter efforts were focused on ensuring optimal clinical and operational execution as we advance our robust and maturing clinical-stage pipeline of best-in-class oncology programs that are reporting multiple value inflection datapoints in the coming months."

First Quarter 2024 Highlights and Recent Developments

Reported positive data from an ongoing investigator-sponsored trial ("IST") Phase 1/2 clinical trial of evorpacept in combination with standard-of-care in patients with relapsed or refractory B-cell non-Hodgkin lymphoma ("R/R B-NHL") in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 9, 2024, in San Diego.
Twenty patients with indolent (n=18) and aggressive (n=2) R/R B-NHL received evorpacept plus standard rituximab and lenalidomide ("R2").
Evorpacept plus R2 was well tolerated with a safety profile similar to historical R2.
The combination achieved promising initial activity with a best overall response rate ("ORR") of 94% and a complete response rate ("CRR") of 83% in patients with indolent R/R B-NHL (R2 historical CRR benchmark is 34%).
The clinical trial is conducted and sponsored by the University of Texas MD Anderson Cancer Center.
Received acceptance of two evorpacept abstracts from the 2024 American Society of Cancer Oncology ("ASCO") Annual Meeting taking place in Chicago from May 31-June 4, 2024.
Evorpacept plus enfortumab vedotin in patients with locally advanced or metastatic urothelial carcinoma: Phase 1a dose escalation results
Session Type and Title: Poster Presentation – Genitourinary Cancer – Kidney and Bladder
Session Date and Time: Sunday, June 2, 2024, 9:00 AM – 12:00 PM CDT
Location: Hall A
Abstract Number: 4575 (ALX Oncology Sponsored Clinical Trial)
Results of a Phase 2 study of evorpacept (ALX148), cetuximab and pembrolizumab in patients with refractory microsatellite stable metastatic colorectal cancer
Session Type and Title: Poster Presentation – Gastrointestinal Cancer – Colorectal and Anal
Session Date and Time: Saturday, June 1, 2024, 1:30 PM – 4:30 PM CDT
Location: Hall A
Abstract Number: 3530 (IST conducted by the University of Colorado Cancer Center and sponsored by the Academic GI Cancer Consortium)
Announced initiation of a Phase 2 IST of neoadjuvant radiation and evorpacept in combination with KEYTRUDA (pembrolizumab) in patients with previously untreated and early-stage locally advanced, resectable, human papillomavirus-mediated oropharyngeal cancer.
The clinical trial is conducted and sponsored by the Hanna and Mark Gleiberman Head and Neck Cancer Center at the University of California, San Diego.
Announced appointment of Allison Dillon, Ph.D., as Chief Business Officer.
Upcoming Clinical Milestones for Evorpacept’s Development Pipeline

Urothelial Carcinoma – Data from a Phase 1b ASPEN-07 clinical trial with PADCEV (enfortumab vedotin-ejfv) (ASCO: Embargo to lift on full abstract May 23, 2024; Poster to be presented on June 2, 2024)
Gastric/Gastroesophageal Junction ("GEJ") Cancer – Top line results from all 122 subjects in a Phase 2 randomized clinical trial of ASPEN-06 (July 2024)
Breast Cancer – Top line results from a Phase 1b I-SPY TRIAL with ENHERTU (fam-trastuzumab deruxtecan-nxki) (Q4 2024)
Head and Neck Squamous Cell Carcinoma – Top line results from a Phase 2 randomized clinical trial of ASPEN-03 with KEYTRUDA (Q4 2024/Q1 2025)
Head and Neck Squamous Cell Carcinoma – Top line results from a Phase 2 randomized clinical trial of ASPEN-04 with KEYTRUDA and chemotherapy (Q4 2024/Q1 2025)
Gastric/GEJ Cancer – Initiation of Phase 3 registrational randomized clinical trial for evorpacept (Q4 2024)
First Quarter 2024 Financial Results:

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2024, were $184.5 million. Subsequent to March 31, 2024, the Company issued additional shares of common stock under its at-the-market ("ATM") offering for approximately $26.2 million in net proceeds, after deducting commissions. The Company believes its cash, cash equivalents and investments, recent proceeds from sales under its ATM offering, along with the ability to draw down an additional $40 million of its term loan are sufficient to fund planned operations well into Q1 2026.

Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended March 31, 2024, were $31.7 million, compared to $24.8 million for the prior-year period. The $6.9 million increase was primarily attributable to increased clinical development costs from an increased number of active trials and patient enrollment as well as manufacturing of clinical trial materials to support a higher number of active clinical trials and future expected patient enrollment related to evorpacept, an increase of in personnel and related costs primarily driven by headcount growth, an increase in stock-based compensation expense related to a reclassification of stock-based compensation from G&A to R&D because of the change in roles for our former Chief Executive Officer who transitioned to the Chief Scientific Officer in September 2023, and an increase in other research costs primarily due to a development milestone payment related to ScalmiBio.

General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended March 31, 2024, were $6.0 million, compared to $7.4 million for the prior year period. The $1.4 million decrease was primarily due to lower stock-compensation expense related to a reclassification of stock-based compensation which increased R&D stock-based compensation as detailed under R&D expenses.
Net loss: GAAP net loss was $35.6 million for the three months ended March 31, 2024, or ($0.71) per basic and diluted share, as compared to a GAAP net loss of $30.2 million for the three months ended March 31, 2023, or ($0.74) per basic and diluted share. Non-GAAP net loss was $28.5 million for the three months ended March 31, 2024, as compared to a non-GAAP net loss of $23.8 million for the three months ended March 31, 2023. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

On May 9, 2024 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported financial results for the first quarter ended March 31, 2024 and provided a business update (Press release, AnaptysBio, MAY 9, 2024, View Source [SID1234642975]).

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"This quarter, we continued to enroll patients globally across three Phase 2 trials for our two best-in-class checkpoint agonists: ANB032, our BTLA agonist, and rosnilimab, our PD-1 agonist. By year end, we anticipate sharing top-line data from ANB032’s Phase 2b trial in atopic dermatitis, as well as moving our two pre-clinical immune cell modulators, ANB033 and ANB101, into clinical development," said Daniel Faga, president and chief executive officer of Anaptys. "Additionally, we are excited to further strengthen our balance sheet by adding $50 million through a capped non-recourse monetization of Jemperli royalties as well as share incremental data from the imsidolimab Phase 3 program."
Updates on Wholly Owned Immune Cell Modulator Pipeline
ANB032 (BTLA agonist antibody)
•Enrollment ongoing for global Phase 2b trial in moderate-to-severe AD
◦160 patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period
◦Reiterating top-line Week 14 data anticipated by year-end 2024
•Primary endpoint in Phase 2b trial to be updated from absolute change in EASI score to EASI-75 at Week 14, which is a well-accepted registrational endpoint that enables more relevant comparisons to benchmark therapies
•Presented posters on previously reported ANB032 preclinical data supporting the modulation of dendritic cell (DC) maturation and function and preclinical graft vs. host disease (GvHD) data at the 2024 American Academy of Dermatology (AAD) Annual Meeting in March 2024 and American Association of Immunologists (AAI) Annual Meeting in May 2024
•Poster presentations are available at View Source
Rosnilimab (PD-1 agonist antibody)
•Enrollment ongoing for global Phase 2b trial in moderate-to-severe RA

◦420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
▪At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI<=10, are eligible to be dosed for an additional 16-week all-active treatment period and then followed for a three-month off-drug follow-up period
◦Reiterating top-line Week 12 data anticipated by mid 2025
•Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC
◦130-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission
▪Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period
◦Reiterating top-line Week 12 data anticipated by H1 2026
•Presented poster on previously reported rosnilimab Phase 1 data and membrane proximal binding epitope to optimize PD-1 agonist signaling at the 19th Congress of the European Crohn’s and Colitis Organisation (ECCO) in February 2024
◦Poster presentation is available View Source
ANB033 (anti-CD122 antagonist antibody)
•Plan to submit an Investigational New Drug (IND) application in Q2 2024
ANB101 (BDCA2 modulator antibody)
•Plan to submit an IND application in H2 2024
Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing
•Announced positive top-line results from its global GEMINI-1 and GEMINI-2 Phase 3 trials evaluating the safety and efficacy of investigational imsidolimab (IL-36R mAb) in patients with generalized pustular psoriasis (GPP)
◦See full press release at View Source
•Plan to submit a comprehensive data abstract for GEMINI-1 and GEMINI-2 to a H2 2024 medical meeting
•Intend to out-license imsidolimab in 2024
Updates on GSK Immuno-Oncology Financial Collaboration
•Announced a $50 million capped non-recourse monetization from amended agreement with Sagard in exchange for additional Jemperli (dostarlimab) royalties
◦See full press release at View Source

•GSK anticipates top-line data in H2 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer
•GSK anticipates top-line data in 2025 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
First Quarter Financial Results and Cash Runway
•Excluding the $50 million in proceeds from the capped non-recourse monetization of Jemperli royalties by Sagard, cash, cash equivalents and investments totaled $370.1 million as of March 31, 2024, compared to $417.9 million as of December 31, 2023, for a decrease of $36.9 million relating primarily to cash used for operating activities as well as a one-time non-operating cash payment of $10.9 million during the quarter.
◦Reiterating cash runway through year-end 2026
•Collaboration revenue was $7.2 million for the three months ended March 31, 2024, compared to $1.4 million for the three months ended March 31, 2023. The change is due primarily to increased royalties recognized for sales of Jemperli.
•Research and development expenses were $37.0 million for the three months ended March 31, 2024, compared to $35.0 million for the three months ended March 31, 2023. The increase was due primarily to development costs for rosnilimab, ANB032 and ANB033 offset by a decrease in development costs for imsidolimab. The R&D non-cash, stock-based compensation expense was $3.5 million for the three months ended March 31, 2024 as compared to $2.8 million in the same period in 2023.
•General and administrative expenses were $12.3 million for the three months ended March 31, 2024, compared to $10.8 million for the three months ended March 31, 2023. The G&A non-cash, stock-based compensation expense was $6.7 million for the three months ended March 31, 2024 as compared to $6.1 million in the same period in 2023.
•Net loss was $43.9 million for the three months ended March 31, 2024, or a net loss per share of $1.64, compared to a net loss of $44.3 million for the three months ended March 31, 2023, or a net loss per share of $1.58.

On May 9, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported financial results for the quarter ended March 31, 2024 (Press release, Guardant Health, MAY 9, 2024, View Source [SID1234642991]).

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First Quarter 2024 Financial Highlights

•Revenue of $168.5 million for the first quarter of 2024, an increase of 31% over the first quarter of 2023
•Reported 46,900 tests to clinical customers and 8,450 tests to biopharmaceutical customers in the first quarter of 2024, representing increases of 20% and 37%, respectively, over the first quarter of 2023
•Reduced free cash flow to $(37.2) million in the first quarter of 2024, compared to $(82.0) million in the prior year
•Raised 2024 annual guidance for revenue to a new range of $675 to $685 million, representing growth of 20% to 21%
•Improved annual free cash flow guidance to $(275) to $(285) million, a reduction of $60 to $70 million compared to 2023
Recent Operating Highlights
•Validated the strength and quality of ECLIPSE clinical data with the study publication in The New England Journal of Medicine
•Launched new service at The Royal Marsden to test advanced NSCLC patients in England through an expanded NHS study
•Presented new data demonstrating the value of epigenomic analysis and methylation sequencing using the Smart Liquid Biopsy platform at the 2024 AACR (Free AACR Whitepaper) Annual Meeting
•Surpassed 500 peer-reviewed publications highlighting Guardant Health technology in scientific literature

"We started the year off very strongly with first quarter revenue growing 31%, driven by both solid volume growth and significant improvements to Guardant360 reimbursement," said Helmy Eltoukhy, co-founder and co-CEO. "In addition to strong topline performance, this was the first quarter of generating positive cash flow in our Therapy Selection business. We also recently surpassed a significant milestone with over 500 peer-reviewed publications highlighting our technology in scientific literature, demonstrating the impact our innovative suite of products have on both patients and the scientific community."
"The publication of ECLIPSE data in The New England Journal of Medicine, one of the world’s leading medical journals, underscores the quality of our clinical data," said AmirAli Talasaz, co-founder and co-CEO. "Our team has worked incredibly hard and is now well-prepared for the upcoming FDA Advisory Committee review on May 23. We are eagerly anticipating the launch of Shield IVD shortly after the expected FDA approval in 2024 and are confident this test is well positioned for rapid adoption."

First Quarter 2024 Financial Results

Revenue was $168.5 million for the first quarter of 2024, a 31% increase from $128.7 million for the corresponding prior year period. Precision oncology revenue grew 38%, to $156.2 million for the first quarter of 2024, from $113.4 million for the corresponding prior year period, driven by an increase in clinical and biopharma testing volume, which grew 20% and 37%, respectively, over the prior year period. The increase in precision oncology revenue was also attributable to an increase in reimbursement for our tests, due to an increase in the Medicare reimbursement rate for our Guardant360 LDT test to $5,000, effective January 1, 2024, and an increase in reimbursement received from commercial payers. Development services and other revenue was $12.3 million for the first quarter of 2024, compared to $15.3 million for the corresponding prior year period.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $103.2 million for the first quarter of 2024, an increase of $27.6 million from $75.6 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 61%, as compared to 59% for the corresponding prior year period. Precision oncology gross margin was 62% in the first quarter of 2024, as compared to 60% in the prior year period. Development services and other gross margin was 51% in the first quarter of 2024, as compared to 48% in the prior year period.

Non-GAAP gross profit was $105.3 million for the first quarter of 2024, an increase of $27.6 million, from $77.7 million for the corresponding prior year period. Non-GAAP gross margin was 63% for the first quarter of 2024, as compared to 60% for the corresponding prior year period.
Non-GAAP gross profit excluding screening was $108.0 million for the first quarter of 2024, an increase of $26.9 million, from $81.1 million for the corresponding prior year period. Non-GAAP gross margin excluding screening was 64% for the first quarter of 2024, as compared to 63% for the corresponding prior year period.

Operating expenses were $202.9 million for the first quarter of 2024, as compared to $209.7 million for the corresponding prior year period. Non-GAAP operating expenses were $176.5 million for the first quarter of 2024, as compared to $188.3 million for the corresponding prior year period.
Net loss was $115.0 million for the first quarter of 2024, as compared to $133.5 million for the corresponding prior year period. Net loss per share was $0.94 for the first quarter of 2024, as compared to $1.30 for the corresponding prior year period. The year-over-year decrease in net loss is primarily due to a $34.4 million year over year improvement in loss from operations, and a $11.8 million increase in interest income, partially offset by a $33.9 million increase in unrealized losses recorded for our investment in Lunit, Inc.
Non-GAAP net loss was $56.4 million for the first quarter of 2024, as compared to $108.5 million for the corresponding prior year period. Non-GAAP net loss per share was $0.46 for the first quarter of 2024, as compared to $1.06 for the corresponding prior year period.
Adjusted EBITDA loss was $61.1 million for the first quarter of 2024, as compared to a $101.0 million loss for the corresponding prior year period.
Free cash flow for the first quarter of 2024 was $(37.2) million, as compared to $(82.0) million for the corresponding prior year period. Cash, cash equivalents, and restricted cash were $1.1 billion as of March 31, 2024.
2024 Guidance
Guardant Health now expects full year 2024 revenue excluding screening to be in the range of $675 to $685 million, representing growth of 20% to 21% compared to full year 2023 This compares to the prior range of $655 to $670 million, representing growth of 16% to 19%. Guardant Health now expects full year 2024 non-GAAP gross margin excluding screening to be in the range of 61% to 63%, compared to the prior range of 60% to 62%. Guardant Health now expects total non-GAAP operating expenses to be in the range of $720 to $730 million, representing a flat to 1% decrease compared to 2023, an improvement compared to the prior range of $740 to $750 million. Guardant Health now expects free cash flow to be in the range of $(275) to $(285) million in 2024, an improvement compared to the prior range of $(320) to $(330) million.
Webcast Information
Guardant Health will host a conference call to discuss the first quarter 2024 financial results after market close on Thursday, May 9, 2024 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

On May 9, 2024 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical‐-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, reported first quarter 2024 financial results and summarized recent developments (Press release, Monopar Therapeutics, MAY 9, 2024, View Source [SID1234643007]).

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Recent Developments

The radiopharma space has had numerous positive recent developments and announcements, from acquisitions to clinical data to reimbursement rates to commercial demand. Since this past December alone, four significant acquisitions have been publicly announced or completed which have had upfront payments ranging from approximately $1 billion to over $4 billion (BMS/RayzeBio, AstraZeneca/Fusion Pharma, Eli Lilly/POINT BioPharma, and Novartis/ Mariana Oncology).

Monopar has been generating promising preclinical data, and recently entered the clinic with its novel, proprietary MNPR-101 radiopharma program targeting the urokinase plasminogen activator receptor (uPAR). Based on these advances, Monopar has made the strategic decision to focus its resources on the assets and capabilities it has been building up in the radiopharma space. As such, the Company is winding down its non-radiopharma programs, including camsirubicin (and its Phase 1b clinical trial) as well as MNPR-202. The Company is targeting launching its second radiopharma clinical trial as early as the end of this year or the first quarter of 2025.

MNPR‐-101 for Radiopharmaceutical Use – First-in-Human Study with MNPR-101-Zr is Now Active

● Received clearance and recently initiated a first-in-human Phase 1 imaging and dosimetry clinical trial with novel radiopharmaceutical MNPR-101-Zr in advanced cancer patients. Further information about the MNPR-101-Zr trial is available at www.ClinicalTrials.gov under study identifier NCT06337084. This study is being led by internationally recognized radiopharmaceutical physician Prof. Rodney Hicks, founder of the Melbourne Theranostic Innovation Centre (MTIC).
● Optimized imaging and therapeutic MNPR-101 radiopharma programs, significantly increasing tumor uptake while minimizing uptake in healthy tissue (link). This work led to in vivo efficacy studies demonstrating near complete elimination of the tumor after a single injection of the MNPR-101 radiopharmaceutical agent.
● Imaged the biodistribution of a therapeutic radioisotope bound to MNPR-101, and demonstrated highly preferential tumor uptake in the tumor consistent with what is seen with the Zr-89 imaging radioisotope (link).
● Filed a provisional patent application to protect the recent advancements and optimizations Monopar has achieved with its MNPR-101 radiopharma programs.
● Announced that Monopar’s abstract on MNPR-101-Zr radiopharma program was selected for presentation at the Society of Nuclear Medicine and Molecular Imaging’s Annual Meeting on June 8-11, 2024.
● Monopar is targeting initiating a Phase 1 clinical study in advanced cancers with its therapeutic radiopharmaceutical MNPR-101-RIT as soon as the end of this year or early next year.

Results for the First Quarter Ended March 31, 2024, Compared to the First Quarter Ended March 31, 2023

Cash and Net Loss

Cash, cash equivalents and short-term investments as of March 31, 2024, were $8.8 million. Monopar projects that its current funds will be sufficient to continue operations at least through June 30, 2025, to continue to conduct and conclude its first-in-human imaging and dosimetry clinical trial with MNPR-101-Zr, and to advance the preclinical MNPR-101-RIT therapeutic program into the clinic. Monopar will require additional funding to advance its preclinical and clinical programs beyond that, and anticipates seeking to raise additional capital within the next 12 months to fund its future operations.

Net loss for the first quarter of 2024 was $1.6 million or $0.10 per share compared to net loss of $2.4 million or $0.19 per share for the first quarter of 2023.

Research and Development (R&D) Expenses

R&D expenses for the first quarter of 2024 were $966,000 compared to $1,653,000 for the first quarter of 2023. This decrease of $687,000 was primarily due to a decrease of $716,000 in Validive clinical trial-related expenses due to the closure of the trial in March 2023, partially offset by a net increase of $29,000 in other R&D expenses.

General and Administrative (G&A) Expenses

G&A expenses for the first quarter of 2024 were $757,000, compared to $872,000 for the first quarter of 2023. This represents a decrease of $115,000 primarily attributed to (1) a decrease in stock-based compensation to the non-employee directors of $70,000 as no equity awards were issued in the first quarter of 2024 compared to the first quarter of 2023, (2) a reduction of $62,000 in patent expenses related to the closure of the Validive trial, and (3) a reduction of stock-based compensation expenses to employees of $16,000 due to the full vesting of the 2020 grants in the fourth quarter of 2023, partially offset by a net increase in consulting, tax services and other G&A expenses of $33,000.