On February 27, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent business highlights (Press release, Personalis, FEB 27, 2025, View Source [SID1234650716]).

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Recent Business Highlights

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Delivered 1,441 total molecular tests in the fourth quarter of 2024, an increase of 52% compared with 945 tests delivered in the third quarter of 2024; delivered 3,285 total molecular tests for the full year of 2024 compared with 177 in 2023

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Submitted for Medicare coverage in early-stage breast cancer

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Collaborators have submitted manuscripts for publication in peer-reviewed journals for all three Personalis focus indications in breast and lung cancer and IO monitoring, with breast cancer accepted for publication

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Expanded the number of clinical studies in progress to over 20

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Raised $50 million with Merck Sharp & Dohme LLC ("Merck") in a direct investment transaction

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Signed a multi-year extension with ModernaTX, Inc. ("Moderna") to utilize ImmunoID NeXT for V940/mRNA-4157, an investigational individualized neoantigen therapy (INT) being jointly developed by Merck and Moderna

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Expanded the commercial agreement with Tempus AI, Inc. ("Tempus") to authorize Tempus to sell NeXT Personal to pharmaceutical and biotechnology companies

"In 2024, we executed very well and are starting 2025 confident our strategy is working and we will "Win in MRD," said Chris Hall, Chief Executive Officer and President. "We expanded our partnership with Tempus, presented compelling clinical data at Medical Conferences, and drove testing growth 52% quarter over quarter ending the year with 1,441 molecular tests in the fourth quarter. Also, we announced a long-term commercial collaboration with Moderna and a strategic investment of $50 million from Merck, endorsing our technology platform and capabilities to support our partners’ initiatives, and providing a pathway to cashflow break-even."

Full Year 2024 Financial Results Compared with 2023

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Revenue of $84.6 million for the full year of 2024 compared with $73.5 million, an increase of 15%

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Revenue from pharma tests and services, enterprise sales, clinical diagnostics, and other customers of $77.2 million for the full year of 2024 compared with $64.1 million, an increase of 20%, despite the expected decrease in revenue from Natera of 20% to $25.4 million for the full year of 2024

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Revenue from population sequencing for the VA MVP of $7.4 million for the full year of 2024, compared with $9.4 million, a decrease of 21%

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Net loss of $81.3 million, and net loss per share of $1.37 based on a weighted-average basic and diluted share count of 59.3 million for the full year of 2024 compared with a net loss of $108.3 million, and net loss per share of $2.25 based on a weighted-average basic and diluted share count of 48.2 million

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Cash, cash equivalents, and short-term investments of $185.0 million as of December 31, 2024; includes the $50.0 million strategic investment from Merck; reduced cash usage from operations and capital equipment additions in 2024 to $46.8 million, compared with $67.2 million

Fourth Quarter 2024 Financial Results Compared with 2023

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Revenue of $16.8 million for the fourth quarter of 2024 compared with $19.7 million for the fourth quarter of 2023, a decrease of 15%, primarily due to the expected decline in revenue from Natera and the VA MVP

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Pharma tests and services, enterprise sales, clinical diagnostics, and other customers of $16.6 million for the fourth quarter of 2024 compared with $18.7 million for the fourth quarter of 2023, a decrease of 11%

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Population sequencing for the VA MVP of $0.2 million for the fourth quarter of 2024 compared with $1.0 million for the fourth quarter of 2023, a decrease of 78%

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Net loss of $16.4 million, and net loss per share of $0.23 based on a weighted-average basic and diluted share count of 72.9 million in the fourth quarter 2024 compared with a net loss of $26.6 million, and net loss per share of $0.54 based on a weighted-average basic and diluted share count of 49.6 million in the fourth quarter of 2023

First Quarter and Full Year 2025 Outlook

Personalis expects the following for the first quarter of 2025:

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Total company revenue to be in the range of $17 to $18 million

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Revenue from pharma tests and services, and all other customers to be in the range of $10 to $11 million

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Revenue from population sequencing and enterprise sales of approximately $7 million

Personalis expects the following for the full year of 2025:

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Total company revenue in the range of $80 to $90 million

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Revenue from pharma tests and services, and all other customers in the range of $62 to $64 million

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Revenue from population sequencing and enterprise sales in the range of $15 to $16 million

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Revenue from clinical tests reimbursed in the range of $3 to $10 million

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Gross margin in the range of 21% to 23%, which is lower than the 32% gross margin for the full year of 2024 as we invest to drive clinical usage ahead of reimbursement.

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Net loss of approximately $85 million

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Cash usage in the range of $75 to $80 million, which is an increase from the $47 million used in 2024 primarily due to investments in the next phase of our "Win in MRD" strategy, inclusive of growing our test volume, expanding clinical studies, and investing in commercial capabilities to drive growth

Webcast and Conference Call Information

Personalis will host a conference call to discuss the fourth quarter and full year 2024 financial results, as well as plans for 2025, after market close on Thursday, February 27, 2025, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 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 February 27, 2025 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported financial results for the fourth quarter and year ended December 31, 2024, and provided a business update (Press release, AnaptysBio, FEB 27, 2025, View Source [SID1234650715]).

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"Rosnilimab’s positive Phase 2b data in rheumatoid arthritis has revealed impressive safety, tolerability and three-month efficacy data that was sustained and surpasses six-month data from competitor all-active, head-to-head trials. In Q2 2025, we will report full clinical and translational data, further validating rosnilimab’s transformative potential to restore immune homeostasis, not only in RA but also in other diseases like ulcerative colitis. We also are excited to report top-line Phase 2 data for rosnilimab in UC moved up to Q4 2025," said Daniel Faga, president and chief executive officer of Anaptys. "Additionally, Phase 1 development of both ANB033 and ANB101 is advancing as planned. With approximately $420 million of cash coming into 2025, we are well capitalized through year-end 2027, which does not include the significant potential residual royalties and milestones from our GSK financial collaboration."
Updates on Asset Portfolio

Rosnilimab (PD-1 depleter and agonist)
•Announced subcutaneously administered rosnilimab, including two once-monthly doses, achieved positive results in 424-patient Phase 2b RA trial and highest-ever reported clinical disease activity index (CDAI) low disease activity (LDA) response over 6 months
◦Key results for the trial were –
▪Achieved statistical significance on primary endpoint at Week 12 on mean change from baseline DAS28-CRP score across all three rosnilimab doses vs. placebo
▪Achieved statistical significance on key secondary endpoints at Week 12 on ACR20, ACR50 and CDAI LDA
▪Demonstrated highest-ever reported responses on key secondary endpoints at Week 14 on ACR20, ACR50, ACR70 and CDAI LDA
▪69% (220/318) of rosnilimab-treated patients achieved CDAI LDA at Week 14 and appear to show sustained CDAI LDA and ACR50 responses and potentially deepening ACR70 responses out to Week 28
▪Robust pharmacological activity observed in reduction of PD-1high T cells, increase in total Tregs and reduction of CRP across all doses
▪Rosnilimab was safe and well tolerated with similar adverse event rates vs. placebo

◦Full clinical and translational data anticipated in Q2 2025
•Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC
◦132-patient trial assessing two dose levels of subcutaneously administered rosnilimab vs. placebo (randomized 1:1:1)
▪Primary statistical analysis at Week 12 on well-established endpoints, including the primary endpoint of change from baseline in modified Mayo score (mMS) and supportive secondary endpoints of clinical response on mMS, clinical remission on mMS and endoscopic remission
▪All patients in all three study arms treat-through to Week 24 and remain blinded to treatment arm. Placebo-treated patients who achieved clinical response on partial modified Mayo score (pmMS) at Week 12 remain on placebo, while placebo-treated patients who are non-responders are crossed over to the high-dose rosnilimab treatment arm
▪Patients who are in clinical response on pmMS at Week 24 are eligible for an additional 26-weeks (50 weeks of total treatment), blinded treatment extension period (TEP)
◦Top-line data anticipated in Q4 2025
•Presented preclinical data in Q4 2024 and Q1 2025 (available at View Source) evaluating –
◦The PD-1 depletion and agonism mechanisms of rosnilimab in vitro with UC patient-derived PBMCs and a mouse model of colitis at the 2024 United European Gastroenterology Week (UEGW)
◦Inflammatory pathway gene expression in PD-1+ conventional and regulatory T cells in human UC tissue and rosnilimab’s effects in a mouse model of colitis at the European Crohn’s and Colitis Organisation (ECCO) Congress
◦Synovial levels of PD-1 and the correlation with disease activity in RA at American College of Rheumatology (ACR) Convergence
ANB033 (CD122 antagonist)
•Enrollment ongoing for Phase 1a trial in healthy volunteers
◦Phase 1b indication to be disclosed at a 2025 R&D event
ANB101 (BDCA2 modulator)
•Investigational new drug (IND) application accepted by FDA
•Phase 1a trial to initiate in healthy volunteers in Q1 2025
Imsidolimab (IL-36 antagonist)
•Announced an exclusive global out-license agreement with Vanda Pharmaceuticals to develop and commercialize imsidolimab (IL-36R antagonist)
◦Anaptys received $15 million, comprised of a $10 million upfront payment and $5 million for existing drug supply
◦Anaptys eligible to receive up to $35 million for future regulatory approvals and sales milestones in addition to a 10% royalty on global net sales
GSK Immuno-Oncology Financial Collaboration
•GSK announced strong commercial performance for Jemperli ($190 million in Q4 2024 sales) with >100% year-over-year growth
•GSK anticipates top-line data in H1 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 and to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and platinum-based chemotherapy

•GSK anticipates top-line data in 2026 from AZUR-1 pivotal Phase 2 trial of dostarlimab monotherapy in patients with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
◦Jemperli received U.S. FDA Breakthrough Therapy Designation for this indication in December 2024
Cash Runway
•Cash and investments of $420.8 million as of Dec. 31, 2024, and reiterating cash runway through year-end 2027
Fourth Quarter and Full Year 2024 Financial Results
•Cash, cash equivalents and investments totaled $420.8 million as of December 31, 2024, compared to $417.9 million as of December 31, 2023, for an increase of $2.9 million due primarily to the $100 million underwritten registered direct offering completed in Q3 and $50.0 million received from the Sagard royalty monetization in Q2 offset by 2024 operating activities.
•Collaboration revenue was $43.1 million and $91.3 million for the three and twelve months ended December 31, 2024, compared to $9.0 million and $17.2 million for the three and twelve months ended December 31, 2023. The increase in non-cash revenue in 2024 is due to $15.0 million and $25.0 million commercial milestones earned for annual Jemperli sales exceeding $250.0 million and $500.0 million during the year and increased royalties recognized for sales of Jemperli. For the year ended December 31, 2024, GSK reported $598.0 million in sales for Jemperli, a greater than 200% sales growth when compared to $175.6 million for the year ended December 31, 2023.
•Research and development expenses were $42.6 million and $163.8 million for the three and twelve months ended December 31, 2024, compared to $33.5 million and $132.3 million for the three and twelve months ended December 31, 2023. The increase was due primarily to development costs for rosnilimab, ANB032, ANB033 and ANB101 offset by a decrease in development costs for imsidolimab. The R&D non-cash, stock-based compensation expense was $3.9 million and $14.8 million for the three and twelve months ended December 31, 2024 as compared to $2.5 million and $10.2 million in the same period in 2023.
•General and administrative expenses were $10.2 million and $42.4 million for the three and twelve months ended December 31, 2024, compared to $10.3 million and $41.9 million for the three and twelve months ended December 31, 2023. The G&A non-cash, stock-based compensation expense was $4.3 million and $19.2 million for the three and twelve months ended December 31, 2024 as compared to $5.6 million and $23.0 million in the same period in 2023.
•Net loss was $21.8 million and $145.2 million for the three and twelve months ended December 31, 2024, or a net loss per share of $0.72 and $5.12, compared to a net loss of $42.2 million and $163.6 million for the three and twelve months ended December 31, 2023, or a net loss per share of $1.59 and $6.08.
▪Full press release can be found at View Source

On February 27, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline and business progress, reiterated key anticipated milestones, and announced fourth quarter and full year 2024 financial results (Press release, Nuvalent, FEB 27, 2025, View Source [SID1234650712]).

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"The efficient execution by the Nuvalent team to date reflects a shared sense of urgency driven by patient need for additional treatment options – a need that we believe has been clearly demonstrated by the robust enrollment momentum in our ARROS-1 and ALKOVE-1 trials," said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. "We believe we are on track to report pivotal data for TKI pre-treated patients from both trials this year and to submit our first NDA by mid-year 2025."

Ms. Noci continued, "In parallel to advancing initial registration paths for zidesamtinib and neladalkib for TKI pre-treated patients, we continue to work with regulators towards our goal of bringing new therapies to all patients with ROS1-positive or ALK-positive NSCLC. Development programs for TKI-naïve patients are underway for both our ROS1 and ALK programs. To ensure patient access to these therapies, we are also pleased to announce the recent launch of global Expanded Access Programs for patients who are eligible and have no other treatment options outside of a clinical trial."

"As we transition towards becoming a fully integrated commercial-stage biopharmaceutical company, we reiterate our commitment to meeting the medical needs of patients by advancing our programs as quickly as possible," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "This is an important time for Nuvalent and with a steady cadence of anticipated milestones across our pipeline this year, a strong balance sheet and a dedicated and proven team at the helm, we believe we are well-positioned to deliver on our near-, mid- and long-term goals."

Recent Pipeline Progress and Anticipated Milestones

ROS1 Program

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Nuvalent has implemented a global Expanded Access Program (EAP) for zidesamtinib for eligible patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously received at least one prior ROS1 tyrosine kinase inhibitor (TKI) and lack satisfactory therapeutic alternatives and are unable to access zidesamtinib through a clinical trial.
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As of December 31, 2024, a total of 430 patients had been enrolled in the Phase 1 and Phase 2 portions of the ongoing ARROS-1 Phase 1/2 trial of zidesamtinib for patients with advanced ROS1-positive NSCLC and other solid tumors, which is designed with registrational intent for TKI pre-treated and TKI-naïve patients with advanced ROS1-positive NSCLC. The company expects to report pivotal data for TKI pre-treated patients with advanced ROS1-positive NSCLC in the first half of 2025 in support of an anticipated New Drug Application (NDA) submission by mid-year 2025, with an initial target indication of TKI pre-treated patients with advanced ROS1-positive NSCLC. The company plans to continue engagement with the U.S. Food and Drug Administration (FDA) on accelerated opportunities towards a potential line-agnostic indication supported by the ongoing TKI-naïve cohort in the Phase 2 portion of the ARROS-1 trial.
ALK Program

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Nuvalent has implemented a global EAP for neladalkib for eligible patients with locally advanced or metastatic ALK-positive NSCLC who have previously received lorlatinib or a second-generation ALK TKI and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.
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As of December 31, 2024, a total of 596 patients had been enrolled in the Phase 1 and Phase 2 portions of the ongoing ALKOVE-1 Phase 1/2 trial of neladalkib for patients with advanced ALK-positive NSCLC and other solid tumors, which is designed with registrational intent for TKI pre-treated patients. The company expects to report pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC by year-end 2025.
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Nuvalent plans to initiate the ALKAZAR Phase 3 trial, its front-line development strategy for the company’s ALK program, in the first half of 2025. The Phase 3 ALKAZAR trial will be a global, randomized, controlled trial designed to evaluate neladalkib versus the current standard of care for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients will be randomized 1:1 to receive neladalkib monotherapy or ALECENSA (alectinib) monotherapy, reflecting input from collaborating physician-scientists and alignment with the FDA.
HER2 Program

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Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2025.
Business Updates

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Appointed Grant Bogle to Board of Directors: As previously announced, Nuvalent appointed Grant Bogle to its board of directors in December 2024. Mr. Bogle brings nearly four decades of proven leadership in building and growing biotechnology companies to the Nuvalent board. Throughout his career, he has served in senior leadership roles at several specialty pharmaceutical and biotechnology companies and worked alongside oncologists as part of the leadership of U.S. Oncology, the largest network of community oncology practices in the United States. He has a proven track record of success in the field of oncology and has guided numerous products from early-stage development to commercialization. Most recently, Mr. Bogle was the Chief Executive Officer at Epizyme, Inc., and oversaw the 2022 acquisition of the company by Ipsen. Prior to that, Mr. Bogle was Senior Vice President and Chief Commercial Officer of TESARO, which was acquired by GlaxoSmithKline in 2018. Earlier, he served as Senior Vice President of Pharmaceutical and Biotech Solutions at McKesson Specialty Health (formerly U.S. Oncology).
Fourth Quarter and Full Year 2024 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $1.1 billion as of December 31, 2024. Nuvalent continues to believe that its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028.
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R&D Expenses: Research and development (R&D) expenses were $69.4 million for the fourth quarter of 2024 and $217.8 million for the year ended December 31, 2024.
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G&A Expenses: General and administrative (G&A) expenses were $16.9 million for the fourth quarter of 2024 and $62.6 million for the year ended December 31, 2024.
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Net Loss: Net loss was $74.8 million for the fourth quarter of 2024 and $260.8 million for the year ended December 31, 2024.

On February 27, 2025 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following investor conferences in March (Press release, MacroGenics, FEB 27, 2025, View Source [SID1234650711]):

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TD Cowen 45th Annual Healthcare Conference (Boston). MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a fireside chat on Wednesday, March 5, 2025, at 10:30am ET. MacroGenics’ management will also participate in one-on-one meetings.

Leerink Partners 2025 Global Healthcare Conference (Miami). Dr. Koenig will participate in a fireside chat on Tuesday, March 11, 2025, at 11:20am ET. MacroGenics’ management will also participate in one-on-one meetings.

Barclays 27th Global Healthcare Conference (Miami). Dr. Koenig will participate in a fireside chat on Wednesday, March 12, 2025, at 2:00pm ET. MacroGenics’ management will also participate in one-on-one meetings.

Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain archived replays of these webcasts on its website for 30 days.

On February 27, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, Janux Therapeutics, FEB 27, 2025, View Source [SID1234650710]).

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"2024 was an exceptional year for Janux as we displayed the potential power of our TRACTr platform in the clinic. We believe the data recently presented from JANX007 demonstrated substantial clinical activity in late line mCRPC patients, supporting our future clinical development plans directed at earlier line patients. With our substantial cash runway, we feel well-positioned to execute on our clinical plans, as well as bring new programs towards the clinic that could provide substantial value to both Janux, and more importantly, the patients we serve," said David Campbell, Ph.D., President and CEO of Janux.

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

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Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in December 2024. As of the November 15, 2024, data cutoff in 16 patients JANX007 displayed:
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High prostate-specific antigen (PSA) response rates: 100% achieved best PSA50 declines.
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Deep PSA declines: 63% achieved best PSA90 declines; 31% achieved best PSA99 declines.
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Durable PSA declines maintained at ≥ 12 weeks: 75% maintained PSA 50 declines; 50% maintained PSA90 declines.
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Encouraging anti-tumor activity: 50% ORR (4/8) and 63% DCR (5/8) (including confirmed and unconfirmed).
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Well-tolerated safety profile: CRS and TRAEs primarily limited to cycle 1 and lower grades.

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Gross proceeds of approximately $402.5 million (before deducting underwriting discounts and commissions and other estimated offering expenses) raised in an underwritten offering of common stock and pre-funded warrants in December 2024.

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Janux to host R&D Day in 2025.
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Janux plans to provide an update on pipeline programs selected for clinical development.

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JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).

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JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).

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Zachariah McIver, D.O., Ph.D. promoted to Chief Medical Officer. Dr. McIver has been instrumental in executing on Janux’s clinical programs. Dr. McIver continues to lead cross-functional teams in the design, implementation, and execution of clinical and correlative study strategies. An accomplished physician-scientist with over 15-years of experience in clinical research, Dr. McIver joined Janux after serving as Amgen’s Executive Medical Director for over 4 years.

An update on JANX007 and JANX008 data is anticipated in 2025. Janux will also be hosting an R&D
Day in 2025.

FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS:

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Cash and cash equivalents and short-term investments: As of December 31, 2024, Janux reported cash and cash equivalents and short-term investments of $1.03 billion compared to $344.0 million at December 31, 2023.

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Research and development expenses: Research and development expenses were $20.8 million for the quarter and $68.4 million for the year ended December 31, 2024, compared to $12.2 million and $54.9 million for the same quarter and year in 2023.

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General and administrative expenses: General and administrative expenses were $8.2 million for the quarter and $41.0 million for the year ended December 31, 2024, compared to $6.4 million and $26.1 million for the same quarter and year in 2023.

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Net loss: Net loss was $20.2 million for the quarter and $69.0 million for the year ended December 31, 2024, compared to $11.8 million and $58.3 million for the same quarter and year in 2023.

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with metastatic castration-resistant prostate cancer (mCRPC). Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline.