On May 8, 2024 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the first quarter of 2024 ended March 31, 2024, and provided recent business highlights (Press release, Personalis, MAY 8, 2024, View Source [SID1234642889]).

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Recent Business Highlights

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The analytical validation for the company’s NeXT Personal MRD test was published in Oncotarget on March 14, 2024. NeXT Personal is the first-to-market ultra-sensitive minimal residual disease (MRD) assay to detect cancer, and monitor therapy response in patients with solid tumor cancers. The study demonstrated a detection threshold of 1.67 parts per million (PPM) of ctDNA with high specificity, which is expected to enable an ultra-sensitive range leading to early cancer recurrence detection.
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Five abstracts focused on MRD in breast cancer, therapy monitoring, and colorectal cancer were accepted for the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) medical conference in June. Two abstracts will be featured as podium presentations.
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NeXT Personal Dx clinical launch proceeding ahead of plan; 338 total molecular tests delivered in Q1, reflecting 100% engagement of NeXT Personal Dx early access clients and strong NeXT Dx growth.

"We began 2024 with strong execution as we delivered revenue of $19.5 million in the first quarter, exceeding the upper-end of our guidance range, and we continue to develop compelling NeXT Personal clinical evidence as we work towards obtaining Medicare coverage," said Chris Hall, Chief Executive Officer. "Our efforts in 2024 are focused on executing on the four pillars of our Win-in-MRD strategy: (1) focusing on cancer types where we believe our test provides the most value, (2) generating robust clinical evidence with top KOLs to support our submission for Medicare coverage, (3) leveraging our early success with biopharma customers to accelerate adoption, and (4) working with Tempus AI to expedite commercialization in a capital-efficient manner."

First Quarter Results

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Total company revenue of $19.5 million in the first quarter of 2024, compared with $18.9 million in the first quarter of 2023
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Revenue from pharma testing and services grew 55% to $9.8 million in the first quarter of 2024 from $6.3 million in the first quarter of 2023
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Revenue from Enterprise customers declined 16% to $8.0 million in the first quarter of 2024, compared with $9.5 million in the first quarter of 2023; this revenue decline was expected in connection with the amended agreement with Natera
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Revenue from population sequencing for the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of $1.5 million in the first quarter of 2024, compared with $3.0 million in the first quarter of 2023

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Other Income of $4.6 million in the first quarter of 2024, and included a non-cash gain of $4.8 million related to fair-value accounting for the outstanding warrants issued to Tempus AI, Inc. (Tempus)

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Net loss of $13.0 million in the first quarter of 2024, compared with a net loss of $28.7 million in the first quarter of 2023

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Cash, cash equivalents, and short-term investments of $95.4 million as of March 31, 2024

Second Quarter and Revised Full Year 2024 Outlook

Personalis expects the following for the second quarter of 2024:

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Total company revenue in the range of $19.5 to $20.5 million
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Revenue from pharma tests, enterprise sales, and other customers in the range of $18.0 to $19.0 million
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Revenue from population sequencing of approximately $1.5 million

Personalis expects the following for the full year of 2024:

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Total company revenue range increased to $76.0 to $78.0 million from $73.0 to $75.0 million
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Revenue from pharma tests, enterprise sales, and all other customers in the range of $68.0 to $70.0 million, which increased from our prior guidance of $65.0 to $67.0 million
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Revenue from population sequencing of approximately $8.0 million
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Non-GAAP net loss of approximately $77.0 million, which decreased from our prior guidance of $80.0 million and does not include any income or expense from the outstanding warrants issued to Tempus
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Cash usage of approximately $62.0 million

Webcast and Conference Call Information

Personalis will host a conference call to discuss the first quarter of 2024 financial results, as well as plans for 2024, after market close on Wednesday, May 8, 2024, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 844-826-3035 for domestic callers or 412-317-5195 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On May 8, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported that Dr. Matt Coffey, President and Chief Executive Officer, will participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference, which is taking place May 14-15, 2024 at the InterContinental New York Barclay in New York, NY (Press release, Oncolytics Biotech, MAY 8, 2024, View Source [SID1234642888]). Additional details on the fireside chat can be found below.

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Date: Wednesday, May 15, 2024
Time: 10:30 a.m. ET
Location: InterContinental New York Barclay Grand Ballroom I, 2nd Floor
Webcast Link: Available by clicking here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, contact your RBC representative or email [email protected].

A live webcast of the Company’s presentation will also be available on the Investor Relations page of Oncolytics’ website (LINK) and will be archived until August 13, 2024.

On May 8, 2024 Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, Olema Oncology, MAY 8, 2024, View Source [SID1234642887]).

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"Our mission at Olema is uniquely focused on advancing the standard of care for women living with cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We are excited for the achievements we are making both with palazestrant, our oral complete ER antagonist program, and now with our KAT6 inhibitor program, OP-3136. We believe palazestrant has the potential to become the backbone endocrine therapy-of-choice for advanced or metastatic breast cancer, and we look forward to presenting new clinical data in combination with ribociclib at the 2024 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress later this month."

First Quarter 2024 Highlights

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Completed enrollment of 60-patient Phase 1b/2 studies of palazestrant (OP-1250) in combination with each of ribociclib and palbociclib.
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Nominated OP-3136, an orally bioavailable KAT6 inhibitor, as a development candidate. OP-3136 demonstrated potent anti-tumor activity alone and in combination with both palazestrant and CDK4/6 inhibitors in preclinical ER+ breast cancer models.
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Announced publication of data in Molecular Cancer Therapeutics describing the design, discovery and optimization of palazestrant.

Upcoming Milestones

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Present interim Phase 1b/2 clinical results of palazestrant in combination with ribociclib at ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress 2024, May 15-17, 2024, in Berlin, Germany.
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Present trial-in-progress poster on OPERA-01, a pivotal Phase 3 monotherapy clinical trial in the second- and third-line setting of ER+/HER2- advanced or metastatic breast cancer, at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, May 31-June 4, 2024, in Chicago, IL.
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Initiate Phase 1b/2 clinical study of palazestrant in combination with mTOR inhibitor, everolimus, in Q3 2024.

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File an Investigational New Drug (IND), application with the U.S. Food and Drug Administration (FDA) for OP-3136 in late 2024 and advance clinical development.

First Quarter 2024 Financial Results

Cash, cash equivalents and marketable securities as of March 31, 2024, were $249.0 million.

Net loss for the quarter ended March 31, 2024, was $31.0 million, as compared to $28.3 million for the quarter March 31, 2023. The increase in net loss for the first quarter was primarily related to increased spending on research and clinical development-related activities as a result of late-stage clinical trials for palazestrant and the advancement of our KAT6 inhibitor program. This increase was offset by decreased spending on general and administrative activities and higher interest income earned from marketable securities.

GAAP research and development (R&D) expenses were $29.9 million for the quarter ended March 31, 2024, as compared to $22.8 million for the quarter ended March 31, 2023. The increase in R&D expenses was primarily related to a $5.0 million milestone payment incurred in connection with the exclusive global licensing agreement entered into in June 2022 between Olema and Aurigene (Aurigene Agreement) associated with the advancement of our KAT6 inhibitor program, and increased spending on clinical development-related activities, as we continue to advance palazestrant into late-stage clinical trials. The increase was offset by decreased spending on clinical pharmacology studies and nonclinical research programs and a one-time restructuring charge recorded in the first quarter of 2023.

Non-GAAP R&D expenses were $26.5 million for the quarter ended March 31, 2024, which included a $5.0 million milestone payment in connection to the Aurigene Agreement and excluded $3.4 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $19.7 million for the quarter ended March 31, 2023, excluding $3.1 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $4.5 million for the quarter ended March 31, 2024, as compared to $6.8 million for the quarter ended March 31, 2023. The decrease in G&A expenses was primarily due to decreased spending on corporate- and legal-related costs, and personnel-related expenses, including a one-time restructuring charge recorded in the first quarter of 2023.

Non-GAAP G&A expenses were $3.0 million for the quarter ended March 31, 2024, excluding $1.5 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $5.2 million for the quarter ended March 31, 2023, excluding $1.5 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

ESMO Breast Cancer Investor Conference Call

Olema will host a webcast and conference call for analysts and investors to review the data being presented at ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress 2024 on Wednesday, May 15, 2024, at 8:00 a.m. ET (2:00 p.m. CEST). Please register for the webcast by visiting the Investors & Media section of Olema’s website at olema.com.

About Palazestrant (OP-1250)

Palazestrant (OP-1250) is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). For more information, please visit www.opera01study.com.

On May 8, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Caroline Litchfield, executive vice president and chief financial officer, is scheduled to participate in a fireside chat at the Bank of America Securities 2024 Healthcare Conference on Wednesday, May 15, 2024, at 1:40 p.m. PDT / 4:40 p.m. EDT (Press release, Merck & Co, MAY 8, 2024, View Source [SID1234642886]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

On May 8, 2024 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in Bank of America Securities 2024 Healthcare Conference (Press release, Kura Oncology, MAY 8, 2024, View Source [SID1234642885]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at 1:40 p.m. ET / 10:40 a.m. PT on May 15, 2024. A live audio webcast of the fireside chat will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay following the event.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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