On November 7, 2023 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 third quarter ended September 30, 2023, and provided a corporate update (Press release, Olema Oncology, NOV 7, 2023, View Source [SID1234637152]).

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"With the recent oral presentation of our Phase 2 monotherapy clinical results at ESMO (Free ESMO Whitepaper) in Madrid, we are already experiencing increased awareness of and interest in our OPERA-01 Phase 3 monotherapy clinical trial," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our Phase 2 study of palazestrant in combination with ribociclib is now rapidly enrolling and we look forward to presenting new palazestrant combination data at SABCS in December, including a Poster Spotlight Discussion for our interim Phase 2 palbociclib combination clinical results. We are proud of the advancements we are making across our business, and as we progress our CERAN and KAT6 programs we remain focused on defining the next generation of targeted therapies for women’s cancers."

Recent Corporate Highlights

● OPERA-01, Olema’s first pivotal Phase 3 clinical trial testing palazestrant as a monotherapy in second- and third-line metastatic breast cancer is ongoing, including clinical site activation and first patient expected to be enrolled in the fourth quarter.
● Presented palazestrant Phase 2 monotherapy clinical study results as an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 in Madrid, Spain, on October 22, 2023. Results demonstrated that, across all 86 heavily pretreated patients, the median progression-free survival (PFS) was 4.6 months with a clinical benefit rate (CBR) of 40%; in patients with ESR1 mutations at baseline, the median PFS was 5.6 months with a CBR of 52%. In a subset analysis of 49 second- or third-line patients with or without prior chemotherapy, the median PFS was 7.2 months and CBR was 48% across all patients, and the median PFS was 7.3 months and CBR
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was 59% in ESR1-mutant patients. Study results support continued development of palazestrant in the OPERA-01 monotherapy Phase 3 pivotal trial.
● Announced the appointment of Mr. Scott Garland, who brings more than 30 years of biopharmaceutical industry experience with deep commercial and executive leadership expertise, to Olema’s Board of Directors.
● Announced the expansion of Olema’s clinical collaboration with Novartis Institutes for BioMedical Research, Inc. (Novartis), increasing the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib to approximately 60 patients.
● Presented new preclinical data regarding the discovery of novel compounds targeting KAT6, an epigenetic target that is dysregulated in breast and other cancers, at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), demonstrating anti-tumor activity in preclinical models of ER+ breast cancer.
● Completed a combined financing for up to $180 million including an equity private placement of approximately $130 million of common stock as well as a new senior secured credit facility with an aggregate principal amount of up to $50 million with Silicon Valley Bank, $25 million of which is currently available.

Upcoming Milestones

● Present palazestrant interim Phase 1b/2 clinical study results in combination with CDK4/6 inhibitor, palbociclib, as a Poster Spotlight Discussion at the 2023 San Antonio Breast Cancer Symposium (SABCS) in December 2023.
● Present palazestrant interim Phase 1b clinical study results in combination with CDK4/6 inhibitor, ribociclib, at SABCS.
● Present trial-in-progress poster for OPERA-01, a randomized, open-label, Phase 3, study of palazestrant vs. standard-of-care treatment for ER+/HER2- advanced or metastatic breast cancer after endocrine and CDK4/6 inhibitor therapy, at SABCS, which will provide details on the trial design, inclusion/exclusion criteria, and trial endpoints.

Third Quarter 2023 Financial Results

Cash, cash equivalents and marketable securities as of September 30, 2023, were $276.9 million.

Net loss for the quarter ended September 30, 2023, was $21.5 million, as compared to $22.7 million for the same period of the prior year. The decrease in net loss was primarily related to decreased spending on general and administrative activities, and higher interest income earned from the marketable securities, which were offset by increased spending on clinical operations and development-related activities as Olema continues to advance palazestrant into late-stage clinical trials.

GAAP research and development (R&D) expenses were $19.5 million for the quarter ended September 30, 2023, as compared to $17.6 million for the quarter ended September 30, 2022. The increase was primarily a result of increased spending on clinical operations and development-related activities as Olema continues to advance palazestrant into late-stage clinical development.

Non-GAAP R&D expenses were $16.7 million for the quarter ended September 30, 2023, excluding $2.8 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $14.8 million for the quarter ended September 30, 2022, excluding $2.8 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found in the tables below.

GAAP general and administrative (G&A) expenses were $3.9 million for the quarter ended September 30, 2023, as compared to $5.6 million for the quarter ended September 30, 2022. The decrease in G&A expenses was primarily due to decreased spending on (i) corporate- and legal-related costs, and (ii) personnel-related expenses, primarily due to lower headcount as a result of the restructuring and portfolio prioritization.

Non-GAAP G&A expenses were $2.6 million for the quarter ended September 30, 2023, excluding $1.3 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $4.1 million for the quarter ended September 30, 2022, 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 in the tables below.

On November 7, 2023 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported its participation at two upcoming investor conferences (Press release, Nkarta, NOV 7, 2023, View Source [SID1234637151]):

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Stifel Healthcare Conference
November 14, 2023
10:55 a.m. ET – fireside chat

Evercore ISI HealthCONx Conference
November 28, 2023
12:30 p.m. ET – fireside chat

A simultaneous webcast of each event will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately 90 days.

On November 7, 2023 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the third quarter ended September 30, 2023 (Press release, Nektar Therapeutics, NOV 7, 2023, View Source [SID1234637150]).

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Cash and investments in marketable securities at September 30, 2023, were $372.7 million as compared to $505.0 million at December 31, 2022. Nektar’s cash and marketable securities are expected to support strategic development activities and operations into the middle of 2026.

"We’ve made significant progress across our pipeline, including initiating a Phase 2b atopic dermatitis study in October and completing plans to start a Phase 2b alopecia areata study in early 2024," said Howard W. Robin, President and CEO of Nektar. "These two studies position us for important and transformative data readouts for rezpegaldesleukin in the first half of 2025. In September, we signed a new clinical study collaboration with cell therapy leader, Cellular Biomedicine Group, who will evaluate NKTR-255 in combination with CBMG’s tumor-infiltrating lymphocyte therapy in advanced non-small cell lung cancer. This study is an example of the potential of NKTR-255 in combination with a range of cell therapies in liquid and solid tumors. Finally, we will end this year in a strong financial position with at least $320 million in cash and investments which provides us with a cash runway into the middle of 2026."

Summary of Financial Results

Revenue in the third quarter of 2023 was $24.1 million as compared to $23.6 million in the third quarter of 2022. Revenue for the first nine months of 2023 was $66.2 million as compared to $70.0 million in the first nine months of 2022.

Total operating costs and expenses in the third quarter of 2023 were $69.0 million as compared to $77.9 million in the third quarter of 2022. Total operating costs and expenses in the first nine months of 2023 were $296.4 million as compared to $393.7 million in the first nine months of 2022. The reduction in operating costs and expenses for both the third quarter and the first nine months of 2023 were due to decreases in research and development expenses, general and administrative expense and restructuring, impairment and costs of terminated program. For the first nine months of 2023, these decreases were partially offset by $76.5 million in non-cash goodwill impairment.

R&D expense in the third quarter of 2023 was $24.1 million as compared to $33.6 million for the third quarter of 2022. For the first nine months of 2023, R&D expense was $84.2 million as compared to $183.6 million in the first nine months of 2022. R&D expense decreased for both the third quarter and first nine months of 2023 due to the wind down of the bempegaldesleukin program.

G&A expense was $21.1 million in the third quarter of 2023 as compared to $22.5 million in the third quarter of 2022. For the first nine months of 2023, G&A expense was $60.1 million as compared to $70.4 million in the first nine months of 2022. G&A expense decreased for both the third quarter and first nine months of 2023 due to the wind down of the bempegaldesleukin program.

Restructuring, impairment and costs of terminated program were $11.4 million in the third quarter of 2023 as compared to $16.8 million in the third quarter of 2022. The amount for the third quarter of 2023 includes $10.2 million in non-cash lease and equipment impairment charges, $0.7 million for the wind down of the bempegaldesleukin program and $0.5 million in severance. The amount for the third quarter of 2022 includes $8.5 million for the wind down of the bempegaldesleukin program, $5.0 million for contract termination and other restructuring costs, $2.1 million in severance and $1.2 million in non-cash lease impairment charges.

For the first nine months of 2023, restructuring, impairment and costs of terminated program were $49.1 million. This amount includes $36.6 million in non-cash lease and equipment impairment charges, $8.0 million in severance and $3.6 million for the wind down of the bempegaldesleukin program.

For the first nine months of 2022, restructuring, impairment and costs of terminated program were $124.4 million. This amount includes $58.5 million in non-cash lease and equipment impairment charges, $29.8 million in severance, $28.9 million for the wind down of the bempegaldesleukin program and $7.1 million in contract termination and other restructuring costs.

Net loss for the third quarter of 2023 was $45.8 million or $0.24 basic and diluted loss per share as compared to a net loss of $59.0 million or $0.31 basic and diluted loss per share in the third quarter of 2022. Net loss in the first nine months of 2023 was $234.0 million or $1.23 basic and diluted loss per share as compared to a net loss of $308.5 million or $1.65 basic and diluted loss per share in the first nine months of 2022. Excluding the $10.2 million in non-cash impairment charges, net loss, on a non-GAAP basis, for the third quarter of 2023 was $35.7 million or $0.19 basic and diluted loss per share. Excluding the $113.1 million in non-cash goodwill and other impairment charges, net loss, on a non-GAAP basis, for the first nine months of 2023 was $120.8 million or $0.64 basic and diluted loss per share.

Third Quarter 2023 and Recent Business Updates

● In September 2023, Nektar announced a clinical study collaboration with Cellular Biomedicine Group Inc. (CBMG) to evaluate NKTR-255 in combination with C-TIL051 in advanced non-small cell lung cancer (NSCLC) patients that are relapsed or refractory to anti-PD-1 therapy. Under the collaboration, CBMG will add NKTR-255 to its ongoing Phase 1 clinical trial being conducted at Duke Cancer Institute. Enrollment for this trial is ongoing.

● In October 2023, Nektar presented final data from the Phase 1b study of rezpegaldesleukin in patients with atopic dermatitis at the 2023 European Academy of Dermatology and Venereology (EADV) Congress.

o Patients with moderate-to-severe AD that were treated with rezpegaldesleukin showed dose-dependent improvements in Eczema Area and Severity Index (EASI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA), and Itch Numeric Rating Scale (NRS) over 12 weeks of treatment compared to placebo, which were sustained post-treatment over an additional 36 weeks.

o At the highest studied dose, the proportion of Daily Life Quality Index (DLQI) responders was 75% and the proportion of Patient Oriented Eczema Measure (POEM) responders was 65% at week 12.

o rezpegaldesleukin was well tolerated with no patients in the rezpegaldesleukin groups experiencing severe, serious, or fatal adverse events, and no anti-rezpegaldesleukin antibodies were detected.

● In October 2023, Nektar initiated a Phase 2b study of rezpegaldesleukin in patients with atopic dermatitis.

Conference Call to Discuss Third Quarter 2023 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, November 7, 2023.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through December 8, 2023.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

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."