On November 7, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a business update and announced financial results for the third quarter ended September 30, 2023 (Press release, Mersana Therapeutics, NOV 7, 2023, View Source [SID1234637149]).

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"Our team has made considerable progress on multiple fronts in recent months as we seek to demonstrate the clinical potential of our next-generation ADC platforms," said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. "With recent clinical presentations at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 affirming B7-H4 as an intriguing oncology target, we are advancing XMT-1660 in Phase 1 dose escalation with plans to initiate dose expansion in 2024. Additionally, we are now preparing to resume enrollment in our Phase 1 clinical trial of XMT-2056, a novel HER2-directed STING-agonist ADC product candidate. We believe this progress and the actions we have taken to right-size the company provide an exciting opportunity to advance our clinical assets to their next milestones."

Mersana’s Recent Activities and Strategic Priorities

Advance XMT-1660 and Mersana’s Dolasynthen Platform: Dolasynthen is Mersana’s next-generation cytotoxic ADC platform that is designed to generate site-specific, homogeneous ADCs, utilizes a proprietary auristatin payload and has the ability to match the drug-to-antibody ratio (DAR) to specific targets. The company is currently advancing a Phase 1 trial of XMT-1660, a B7-H4-directed Dolasynthen ADC with a precise, target-optimized DAR 6, and it has begun to enroll patients in backfill cohorts at clinically relevant doses as part of the dose escalation design. Mersana expects to complete the dose escalation portion of this Phase 1 clinical trial by the end of 2023 and initiate the dose expansion portion of the trial in 2024. Additionally, Mersana is supporting Janssen Biotech, Inc. under a collaboration and license agreement focused on discovering novel Dolasynthen ADCs for up to three targets. In the third quarter of 2023, Mersana received $6 million in milestone payments from this agreement.

Advance XMT-2056 and Mersana’s Immunosynthen Platform: Immunosynthen is Mersana’s proprietary STING-agonist platform that is designed to generate systemically administered ADCs that locally activate STING signaling in both tumor-resident immune cells and in antigen-expressing cells to unlock the anti-tumor potential of innate immune stimulation. Mersana recently announced the lifting of the U.S. Food and Drug Administration’s clinical hold on the Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen ADC candidate that targets a novel HER2 epitope, and work is now underway to resume enrollment in the trial. In August 2022, Mersana entered into a global collaboration providing GSK plc with an exclusive option to co-develop and commercialize XMT-2056. GSK has not exercised this option to date. Additionally, Mersana is supporting Merck KGaA, Darmstadt, Germany under a collaboration and license agreement that focuses on discovering novel Immunosynthen ADCs for up to two targets.

UPLIFT Data Analysis

In the third quarter of 2023, the company reported top-line data from UPLIFT, its Phase 2 clinical trial of upifitamab rilsodotin (UpRi), that showed the trial did not meet its primary endpoint. UpRi is an ADC targeting the sodium-dependent phosphate transport protein NaPi2b that was developed utilizing the company’s first-generation Dolaflexin platform. Mersana is completing its analysis of UPLIFT results and plans to share detailed efficacy and safety data with the medical and scientific community in the first half of 2024.

Third Quarter 2023 Financial Results

Net cash used in operating activities for the third quarter of 2023 was $46.1 million.
Cash, cash equivalents and marketable securities as of September 30, 2023 were $241.0 million, compared to $280.7 million as of December 31, 2022. Mersana expects that its available funds will be sufficient to support its current operating plan commitments into 2026.
Collaboration revenue for the third quarter of 2023 was $7.7 million, compared to $5.6 million for the same period in 2022. The year-over-year increase was primarily related to Mersana’s collaboration agreement with Merck KGaA, Darmstadt, Germany.
Research and development (R&D) expenses for the third quarter of 2023 were $30.5 million, compared to $50.6 million for the same period in 2022. The decline in R&D expenses was primarily related to reduced manufacturing and clinical costs related to UpRi and XMT-2056 and reduced employee compensation. Included in third quarter 2023 R&D expenses were $2.2 million in non-cash stock-based compensation expenses.
General and administrative (G&A) expenses for the third quarter of 2023 were $12.9 million, compared to $14.6 million during the same period in 2022. The year-over-year decline in G&A expenses was primarily related to reduced consulting and professional services fees and reduced employee compensation. Included in third quarter 2023 G&A expenses were $1.8 million in non-cash stock-based compensation expenses.
Mersana incurred $8.2 million in restructuring expenses for the third quarter of 2023 related primarily to severance-related costs and contract termination expenses.
Net loss for the third quarter of 2023 was $41.7 million, or $0.35 per share, compared to a net loss of $59.8 million, or $0.61 per share, for the same period in 2022.
Conference Call Reminder
Mersana will host a conference call today at 8:00 a.m. ET to discuss business updates and its financial results for the third quarter of 2023. To access the call, please dial 877-270-2148 (domestic) or 412-902-6510 (international). A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.

On November 7, 2023 Manhattan BioSolutions, Inc. ("Manhattan Bio"), an emerging biotechnology company developing new classes of precision biologics for the treatment of advanced cancers, reported a discovery collaboration agreement with the National Cancer Institute (NCI), part of the US National Institutes of Health (NIH), and Binghamton University (Press release, Manhattan BioSolutions, NOV 7, 2023, View Source [SID1234637148]). The collaboration will utilize novel monoclonal antibodies developed by NCI as well as novel tumor-cleavable linker-payload technology invented at Binghamton University to generate and validate novel antibody-drug conjugates (ADCs) for the treatment of pediatric Rhabdomyosarcoma (RMS).

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ADCs harness the targeting ability of antibodies to selectively deliver drugs directly to cancer cells or to the tumor microenvironment while sparing healthy tissues. RMS is the most common pediatric sarcoma; however, the survival for patients with relapsed and metastatic disease remains dismal. Under the agreement, Manhattan Bio, NCI and Binghamton University will jointly conduct preclinical experiments to develop ADC targeting an oncogenic cell surface receptor that is highly overexpressed in RMS as well as in other solid tumors.

The lead investigator is Javed Khan, MD, Senior Investigator and Deputy Chief of the Genetics Branch at the NCI Center for Cancer Research. The antibodies discovered by the team of Dr. Javed Khan will be conjugated with proprietary protease-cleavable topoisomerase 1 inhibitor warheads, invented by Dr. Nathan Tumey’s laboratory at Binghamton University. The resulting ADCs will be evaluated in preclinical models of RMS. This discovery collaboration builds on an earlier commercial evaluation license agreement between Manhattan Bio and the NCI.

"We are extremely pleased to partner with these prominent research institutions to accelerate the development of transformative targeted therapies for children with cancer," said Dr. Borys Shor, Chief Executive Officer of Manhattan Bio. "Our industry expertise in ADC development complements Dr. Khan’s world-class leadership in pediatric oncology research, which enables us to advance the pipeline and bring new hope to young patients battling RMS."

On November 7, 2023 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T‑cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors, reported financial results and business highlights for the third quarter ended September 30, 2023 (Press release, Lyell Immunopharma, NOV 7, 2023, View Source [SID1234637147]).

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"We remain on track to present initial data from each of our two lead Phase 1 programs next year and remain confident in our science, our product candidates and our ability to deliver meaningful advances in cell therapy to patients with solid tumors," said Lynn Seely, M.D., Lyell’s President and CEO. "As we continue to generate clinical data from our two lead programs, we have also taken important steps toward reducing costs and manufacturing time for cell therapies through our proof-of-concept CAR T-cell manufacturing collaboration with Cellares and advances in our Epi-R P2 manufacturing process. We are focused on strengthening our ability to fully elucidate the potential of the currently disclosed product candidates in our pipeline through multiple clinical milestones and have extended our ability to fund operations into 2027. We have restructured our company to prioritize investment in our clinical stage programs and core research platforms and have streamlined operations. In doing so we are parting ways with talented and valued Lyellites. Tina Albertson, M.D., Ph.D., our Chief Medical Officer is also leaving the company. We thank our departing colleagues for their many contributions that have helped advance our mission."

With key infrastructure now in place and a maturing company focus, the company is prioritizing investment in its most value enhancing clinical stage product candidates and core research platforms and has scaled down investment in certain early-stage research programs and stage gated certain other expenses. An approximately 25% reduction in workforce associated with this prioritization is expected to be completed in the fourth quarter of 2023.

Third Quarter Updates and Recent Business Highlights

Lyell is advancing four wholly-owned product candidates with two product candidates in Phase 1 clinical development, LYL797 and LYL845. Two additional product candidates, LYL119 and a second-generation tumor infiltrating lymphocyte (TIL) product candidate, are in preclinical development.

LYL797 – A ROR1-targeted Chimeric Antigen Receptor (CAR) T-cell product candidate genetically reprogrammed to overexpress c-Jun and epigenetically reprogrammed using Lyell’s proprietary Epi-R manufacturing protocol, designed for differentiated potency and durability

Enrollment in the Phase 1 clinical trial of LYL797 is ongoing. The study includes patients with relapsed or refractory triple-negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC).
Initial clinical and translational data from at least 20 patients in the Phase 1 trial of LYL797 are expected in the first half of 2024.
Initiated a CAR T-cell manufacturing proof-of-concept collaboration with Cellares as part of an overall manufacturing strategy to build scale and reduce cost. Under the collaboration, the companies have agreed on a proof-of-concept technology transfer process for the manufacture of Lyell’s LYL797 CAR T-cell therapy, using Cellares’ Cell Shuttle.
Announced initial results from Lyell’s ROR1 screening program indicating that expression of ROR1 in TNBC and NSCLC, 53% (N=77) and 33% (N=18), respectively, is consistent with what has been reported in the literature. The screening program is designed to support Lyell’s current and future clinical trials.
LYL797 Trial in Progress poster was presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in San Diego on November 1-5, 2023.
LYL845 – A novel epigenetically reprogrammed TIL product candidate designed for differentiated potency and durability

Enrollment in the Phase 1 clinical trial for LYL845 is ongoing. The study includes patients with relapsed and/or refractory metastatic or locally advanced melanoma, NSCLC and colorectal cancer.
Initial clinical data from the Phase 1 trial of LYL845 are expected in 2024.
Preclinical data on the Epi-R P2 manufacturing process designed to shorten TIL manufacturing time without impacting cell number and phenotype were presented at SITC (Free SITC Whitepaper). Epi-R P2 is expected to be incorporated into the Phase 1 trial in 2024.
LYL845 Trial in Progress poster was presented at SITC (Free SITC Whitepaper).
LYL119 – A ROR1-targeted CAR T-cell product candidate incorporating Lyell’s four stackable reprogramming technologies for enhanced cytotoxicity

LYL119 is a ROR1-targeted CAR T-cell product enhanced with Lyell’s four novel, stackable genetic and epigenetic reprogramming technologies: c-Jun overexpression, NR4A3 knockout, Epi-R manufacturing protocol and Stim-R T-cell activation technology.
An investigational new drug (IND) application for LYL119 is expected to be submitted in the first half of 2024.
An abstract highlighting preclinical development of LYL119 was presented at SITC (Free SITC Whitepaper).
Rejuvenation – Novel partial reprogramming technology designed to maintain T-cell identity while reducing cells’ epigenetic age

An abstract highlighting rejuvenation of TIL through partial reprogramming was presented at SITC (Free SITC Whitepaper).
Third Quarter Financial Results

Lyell reported a net loss of $50.9 million for the third quarter ended September 30, 2023, compared to a net loss of $70.3 million for the same period in 2022. Non‑GAAP net loss, which excludes non-cash stock-based compensation, changes in the estimated fair value of success payment liabilities and certain non-cash investment charges, was $43.0 million for the third quarter ended September 30, 2023, compared to $43.7 million for the same period in 2022.

Revenue

Revenue was approximately zero for both the third quarter ended September 30, 2023 and 2022. No research and development pursuant to our collaboration and license agreement with GlaxoSmithKline (GSK Agreement) was performed in the third quarter of 2023 due to the termination of the GSK Agreement in December 2022.

On November 7, 2023 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, reported that topline results met primary and secondary endpoints for its Phase 2 Dose-Finding OraGrowtH210 Trial and Phase 2 Pharmacokinetic/Pharmacodynamic (PK/PD) OraGrowtH212 Trial evaluating oral LUM-201 for subjects with moderate pediatric growth hormone deficiency (PGHD) who screened PEM-positive utilizing Lumos Pharma’s predictive enrichment marker (PEM) strategy (Press release, Lumos Pharma, NOV 7, 2023, View Source [SID1234637146]). Lumos also announced its financial results for the quarter ended September 30, 2023.

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"With the end of Phase 2 readout from our OraGrowtH210 and OraGrowtH212 trials announced today, we are thrilled that these data support advancing our clinical program towards a pivotal Phase 3 trial for potentially the first oral therapeutic for moderate PGHD," said Rick Hawkins, Chairman and CEO of Lumos Pharma. "Data confirm the optimal dose is 1.6 mg/kg/day LUM-201 to advance to Phase 3, and preliminary data show durability out to 24 months of treatment. Additionally, the OraGrowtH212 data reaffirms our confidence in our oral compound’s unique mechanism of action, the importance of the natural, pulsatile release of growth hormone, and its impact on restoring growth."

Recent Highlights

•Phase 2 OraGrowtH210 and PK/PD OraGrowtH212 Trials met all primary and secondary endpoints. Data from the topline Phase 2 OraGrowtH210 Trial demonstrated that the 1.6 mg/kg/day LUM-201 dose produced a mean annualized height velocity (AHV) of 8.2 cm/yr at six months on treatment for moderate PGHD subjects, in line with historical data in moderate PGHD patients1,2,3,4. Additionally, at twelve months on treatment, a durable effect was also observed with LUM-201 achieving AHV of 8.0 cm/yr at the 1.6 mg/kg dose, within the targeted 2 cm/yr margin of the comparator injectable rhGH arm. Data also provided preliminary validation of the PEM strategy, with prespecified primary and secondary outcomes met, de-risking our patient selection for our Phase 3 program. Data from the OraGrowtH212 Trial confirmed that LUM-201’s unique pulsatile mechanism produces an increase in the growth rates by restoring growth hormone secretion and IGF-1 to within normal ranges. The safety profile for LUM-201 remained clean throughout both Phase 2 trials, with no safety concerns identified in either of our Phase 2 trials conducted thus far. For a link to the Company’s conference call and presentation of the data refer to the Events & Presentations page in the Investors & Media section of the Company’s website.

•OraGrowtH212 Trial Data Presented at the 2023 annual meeting of the European Society for Paediatric Endocrinology. An oral presentation of the deconvolution analysis of growth hormone (GH) concentration sampled over 12 hours at baseline and after 6 months of therapy with daily oral LUM-201 illustrated how treatment with LUM-201 increases AHV, total GH secretion, and serum IGF-1 and IGFBP3 for individuals with moderate PGHD. Measured at 6 months compared to baseline, data showed a 60% increase in GH secretion to a level comparable to established values in normal healthy children and a 62% increase in AHV.

•Independent Panel of Renowned Pediatric Endocrinologists Discussed PGHD and Therapeutic Landscape. On September 5, 2023, a panel of five pediatric endocrinologists participated in a webinar where they discussed the benefits that the oral therapeutic LUM-201 candidate may provide compared to current injectable therapeutic options.

Upcoming Events

•Virtual KOL Event Planned. The Company plans to host a virtual KOL Event on December 6th to discuss topline results from OraGrowtH210 and OraGrowtH212 trials in greater detail and provide updates on clinical and corporate strategy. Management will be joined by the following three esteemed thought leaders in the field of endocrinology:
•Andrew Dauber, MD, Chief of Endocrinology at Children’s National Medical Center, Washington, D.C.
•Fernando Cassorla, MD, Chief of Pediatric Endocrinology at the Institute of Maternal and Child Research, University of Chile
•Leslie A. Soyka, MD, Chief of Pediatric Endocrinology, UMass Memorial Medical Center; Associate Professor, UMass Chan Medical School, Worcester, MA

Access information regarding the KOL Event will be provided at a later date.

1 Blum et al JES 2021, 2 Lechuga-Sancho et al JPEM 2009, 3 Ranke et al JCEM 2010, 4 For all OraGrowtH Trial AHV values, ANCOVA Model Terms: treatment, Age at dose 1, Sex, Baseline HT SDS, Baseline BMI SDS, Baseline IGF-1 SDS, LUM-201 PEM, Baseline BA Delay

Financial Results for the Quarter Ended September 30, 2023

•Cash Position – Lumos Pharma ended the quarter on September 30, 2023 with cash, cash equivalents and short-term investments totaling $42.7 million compared to $67.4 million on December 31, 2022. The Company expects cash use of approximately $9.0 to $10.0 million in the fourth quarter of 2023. Cash on hand as of September 30, 2023 is expected to support operations through the third quarter of 2024, inclusive of the activities related to planning and initiation of a pivotal Phase 3 clinical trial.
•R&D Expenses – Research and development expenses were $5.0 million for the quarter ended September 30, 2023, compared to $4.1 million for the same period in 2022, primarily due to an increase of $0.9 million in clinical trial expenses and $0.2 million in consulting expenses, offset by a decrease of $0.2 million in personnel-related expenses.

Exhibit 99.1

•G&A Expenses – General and administrative expenses were $3.9 million for the quarter ended September 30, 2023, compared to $3.9 million for the same period in 2022, primarily due to an increase of $0.3 million in personnel-related expenses offset by a $0.3 million decrease in royalty expense.
•Net Loss – The net loss for the quarter ended September 30, 2023 was $8.3 million compared to a net loss of $7.3 million for the same period in 2022.
•Lumos Pharma ended the third quarter 2023 with 7,914,582 shares outstanding.

About Lumos Pharma’s Clinical Trials

Phase 2 OraGrowtH210 Trial Design

The OraGrowtH210 Trial is a multi-site, global trial evaluating orally administered LUM-201 at three dose levels (0.8, 1.6, 3.2 mg/kg/day) compared to daily injectable recombinant human growth hormone (rhGH) 34 µg/kg/day in 82 subjects diagnosed with moderate PGHD. The trial population was enriched for subjects responsive to LUM-201 during screening by applying the specific PEM cutoffs of a baseline IGF-1 value > 30 ng/ml and a peak growth hormone value of ≥ 5 ng/ml after administering a single dose of 0.8 mg/kg of LUM-201 to treatment-naïve PGHD patients. The study was not designed to evaluate efficacy and demonstrate non-inferiority to daily GH.

OraGrowtH212 Trial Design

The OraGrowtH212 Trial is a single site, open-label trial evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) effects of oral LUM-201 in up to 24 treatment-naïve PGHD subjects at two dose levels, 1.6 and 3.2 mg/kg/day. Every subject in the OraGrowtH212 Trial was PEM-positive and, therefore, enriched for responsiveness to LUM-201.

Switch Study, OraGrowtH213 Trial, Evaluating LUM-201 in OraGrowtH210 Subjects Previously on rhGH

The OraGrowtH213 Trial is an open-label, multi-center, Phase 2 trial evaluating the growth effects and safety of LUM-201 following 12 months of daily rhGH in up to 20 idiopathic PGHD subjects who have completed the OraGrowtH210 Trial. Subjects will be administered LUM-201 at a dose level of 3.2 mg/kg/day for up to 12 months.

On November 7, 2023 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 third quarter ended September 30, 2023, and provided a business update (Press release, Janux Therapeutics, NOV 7, 2023, View Source [SID1234637145]).

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"We are pleased with the enrollment in the two clinical studies for our PSMA-TRACTr JANX007 and our EGFR-TRACTr JANX008," said David Campbell, Ph.D., President and CEO of Janux. "As we enter 2024, equipped with a strong financial foundation, we are committed to advancing these clinical programs and expanding our pipeline so that we can rapidly bring forward new meaningful therapies for cancer patients."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

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

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

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PD-L1xCD28 TRACIr (JANX009) IND-enabling studies completed.

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TROP2-TRACTr development candidate identification completed.

Janux anticipates providing an update on its clinical programs in 2024.

THIRD QUARTER 2023 FINANCIAL HIGHLIGHTS:

•
Cash and cash equivalents and short-term investments: As of September 30, 2023, Janux reported cash and cash equivalents and short-term investments of $349.7 million compared to $327.0 million at December 31, 2022, which we project will be sufficient to fund our current operating plan through 2027 to generate Phase 1b data for our PSMA and EGFR-TRACTr programs.

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Research and development expenses: For the quarter ended September 30, 2023, Janux reported research and development expenses of $11.9 million compared to $13.7 million for the comparable period in 2022.

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General and administrative expenses: For the quarter ended September 30, 2023, Janux reported general and administrative expenses of $6.4 million compared to $6.1 million for the comparable period in 2022.

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Net loss: For the quarter ended September 30, 2023, Janux reported a net loss of $11.6 million compared to $16.7 million for the comparable period in 2022.

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s second clinical candidate, JANX008, is a TRACTr that targets EGFR and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. Janux’s TRACIr drug candidate, JANX009, is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells for the treatment of solid tumors. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.