On May 9, 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 first quarter ended March 31, 2023, and provided a corporate update (Press release, Olema Oncology, MAY 9, 2023, View Source [SID1234631285]).

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"We are on track for the initiation of our first pivotal Phase 3 clinical trial in the second half of this year," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our ongoing Phase 2 studies continue to generate data in support of our underlying thesis that OP-1250 has the potential to become a best-in-class complete estrogen receptor antagonist and improve upon the current standard of care in the treatment of ER+/HER2- metastatic breast cancer. We look forward to presenting our next clinical update at the 2023 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in mid-May, and we believe we are well-positioned to achieve our goal to significantly improve endocrine therapy for women living with breast cancer."

Anticipated Upcoming Milestones

● Present interim Phase 2 clinical study results of OP-1250 in combination with CDK4/6 inhibitor (palbociclib) at the 2023 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in Berlin, Germany, in a poster presentation on May 12, 2023.
● Present trials-in-progress clinical study overview of OP-1250 in combination with ribociclib or alpelisib in a poster presentation at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, June 2-6, 2023, in Chicago, IL.
● Initiate a pivotal Phase 3 monotherapy clinical trial in the second- and third-line setting of ER+/HER2- advanced or metastatic breast cancer in the second half of 2023.
● Present Phase 2 monotherapy clinical study results in the second half of 2023.
● Present Phase 1b clinical study results of OP-1250 in combination with CDK4/6 inhibitor (ribociclib) in the second half of 2023.

First Quarter 2023 Financial Results

Cash, cash equivalents and marketable securities as of March 31, 2023, were $186.0 million. Olema anticipates that this balance will be sufficient to fund operations into 2025.

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Net loss for the quarter ended March 31, 2023, was $28.3 million, as compared to $23.0 million for same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development (R&D) activities, and personnel-related costs, including a one-time restructuring charge of $2.8 million. The increase in R&D spending was partially offset by a decrease in general and administrative (G&A) costs.

GAAP R&D expenses were $22.8 million for the quarter ended March 31, 2023, as compared to $16.0 million for the quarter ended March 31, 2022. The increase in R&D expenses was primarily related to increases in advancing ongoing clinical studies of OP-1250 and associated manufacturing costs, nonclinical research and discovery program activities, and personnel-related expenses, including a one-time restructuring charge of $1.8 million.

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. Non-GAAP R&D expenses were $12.9 million for the quarter ended March 31, 2022, respectively, excluding $3.1 million non-cash stock-based compensation expense, respectively. 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 $6.8 million for the quarter ended March 31, 2023, as compared to $7.2 million for the quarter ended March 31, 2022. The decrease in G&A expenses was primarily due to lower corporate costs, and personnel-related expenses, including non-cash stock-based compensation expense. The decrease in spending was partially offset by a one-time restructuring charge of $1.0 million.

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. Non-GAAP G&A expenses were $5.3 million for the quarter ended March 31, 2022, excluding $1.9 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.

On May 9, 2023 Nusano, Inc., a company reshaping the production of cancer-fighting radioisotopes, reported it will participate in a fireside chat at the 2nd Annual Guggenheim Securities Radiopharmaceuticals Day in New York City on Monday, May 15, 2023 (Press release, Nusano, MAY 9, 2023, View Source [SID1234631284]).

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WHAT: Guggenheim Securities Fireside Chat
WHO: Chris Lowe, CEO, Nusano
Howard Lewin, COO and Co-Founder, Nusano
WHEN:
May 15, 2023
3:55 – 4:20 p.m. EST
WHERE: New York, NY

Lowe and Lewin will discuss how Nusano’s proprietary ion source and production platform are poised to supply desperately needed medical radioisotopes to support patient care and accelerate cancer therapeutics.

On May 9, 2023 Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the first quarter ended March 31, 2023 (Press release, Nektar Therapeutics, MAY 9, 2023, View Source [SID1234631283]).

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Cash and investments in marketable securities at March 31, 2023, were $456.8 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 at least the middle of 2026.

"With Nektar regaining full rights to rezpegaldesleukin, we are already making progress towards initiating a Phase 2b study in atopic dermatitis," said Howard W. Robin, President and CEO of Nektar. "We are confident that our focus on immunology is the best path forward to bring important potential therapies to patients and create shareholder value. Based on feedback from key opinion leaders in atopic dermatitis, we are enthusiastic about the future prospects for rezpegaldesleukin in a significant and growing biologic treatment landscape. Finally, we are working diligently to advance our immunology research pipeline with the goal of advancing a new IND candidate next year."

Summary of Financial Results

Revenue in the first quarter of 2023 was $21.6 million as compared to $24.8 million in the first quarter of 2022.

Total operating costs and expenses in the first quarter of 2023 were $156.3 million as compared to $141.4 million in the first quarter of 2022. Operating costs and expenses for the first quarter include $76.5 million in non-cash goodwill impairment, $13.2 million in other non-cash impairment charges primarily related to lease assets, and $8.0 million in other restructuring costs, offset by decreases in R&D and G&A expenses.

R&D expense in the first quarter of 2023 was $30.5 million as compared to $107.3 million for the first quarter of 2022. R&D expense decreased primarily due to the wind down of the bempegaldesleukin program.

G&A expense was $21.1 million in the first quarter of 2023 as compared to $27.3 million in the first quarter of 2022. G&A expense decreased primarily due to the wind down of the bempegaldesleukin program.

Restructuring, impairment and costs of the terminated program were $21.2 million in the first quarter of 2023 as compared to $1.5 million in the first quarter of 2022. The amount for the first quarter of 2023 includes $13.2 million in non-cash lease and equipment impairment charges, $5.5 million in severance, and $2.5 million in other costs.

Net loss for the first quarter of 2023 was $137.0 million or $0.73 basic and diluted loss per share as compared to a net loss of $90.4 million or $0.49 basic and diluted loss per share in the first quarter of 2022. Excluding the $89.7 million in non-cash goodwill and other impairment charges, net loss, on a non-GAAP basis, for the first quarter of 2023 was $47.3 million or $0.25 basic and diluted loss per share.

First Quarter 2023 and Recent Business Updates

● On April 27, 2023, Nektar announced that it will be regaining the full rights to rezpegaldesleukin from Eli Lilly and Company. Nektar plans to move forward with rezpegaldesleukin and will initiate a Phase 2b study in patients with moderate-to-severe atopic dermatitis in 2023. The company will also explore other auto-immune indications for the development plan for rezpegaldesleukin.

● On April 17, 2023, Nektar announced a strategic reprioritization and cost restructuring plan that includes a new pipeline focus on immunology, as well as several cost reduction initiatives.

Conference Call to Discuss First 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, May 9, 2023.

The 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 June 4, 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 May 9, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in therapeutic monoclonal antibody space, reported that the Company has been selected for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting held in Chicago on June 2-6, 2023 (Press release, Nascent Biotech, MAY 9, 2023, View Source [SID1234631282]). The poster presentation, entitled "Phase I Study of Pritumumab in Brain Cancer", will take place from 1:15-4:15 PM CDT on June 3rd, during the "Central Nervous Systems Tumors" session in Hall A of McCormick Place Convention Center. ASCO (Free ASCO Whitepaper) is the largest clinical oncology conference that brings together cancer leaders from across the globe to discuss the latest cutting-edge research.

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The Company will have a clinical trials medical team member presenting the pivotal results from the NAS-101 trial, and interested parties are welcome to stop by the poster (board #410). The poster will also be available for download after the conference by contacting [email protected].

Nascent Biotech therapeutic antibody Pritumumab (PTB) is a natural human antibody originally isolated from lymph nodes of a patient with cervical cancer. This monoclonal antibody targets cell surface Vimentin (also referred to as ectodomain vimentin), shown to be significantly expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy that binds the tumor and recruits the host immune system to eliminate cancer cells.

On May 9, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported financial results for the first quarter 2023 along with recent pipeline and corporate updates (Press release, Mirati, MAY 9, 2023, View Source [SID1234631281]).

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"Today we are pleased to share the significant progress made during the first quarter of 2023, highlighted by our first full quarter of sales for KRAZATI, which we believe is the best-in-class KRASG12C inhibitor. This is just the beginning of our journey with KRAZATI, as we continue to advance our broad development plan in lung cancer and across other indications and lines of therapy," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "In addition, we advanced our robust portfolio of potential best-in-class clinical programs, including MRTX1133, our KRASG12D inhibitor, MRTX1719, our MTA cooperative PRMT5 inhibitor, MRTX0902, our SOS1 inhibitor and sitravatinib, our TAM receptor inhibitor. Looking ahead, we remain committed to executing on our strategy to advance our pipeline of targeted oncology programs to positively impact the lives of people living with cancer."

Pipeline Updates

Adagrasib (Potent and selective KRASG12C inhibitor)

•The Company presented updated clinical data for adagrasib as a targeted treatment for KRASG12C-mutated advanced pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer and other solid tumors at the April session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series Program. In addition, the Journal of Clinical Oncology published these findings as a Rapid Communication.

•Adagrasib was included as the only KRAS inhibitor in the National Comprehensive Cancer Network guidelines for Central Nervous System Cancers for patients with KRASG12C -mutated non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases and for KRASG12C -mutation positive pancreatic adenocarcinoma cancer patients.

•The Company is on track to complete supplemental New Drug Application (sNDA) for third-line and beyond colorectal cancer by year-end 2023.

•The Company continues to enroll in KRYSTAL-10, a Phase 3 registrational clinical study in second-line colorectal cancer patients, evaluating the combination of adagrasib plus cetuximab versus chemotherapy. The Company expects to complete enrollment by year-end 2023.

•Enrollment ongoing in KRYSTAL-12, a Phase 3 clinical study of adagrasib versus docetaxel in second line NSCLC. The Company plans to share data from this study in 2024.

•The Company plans to share updated first-line NSCLC data of the combination of adagrasib with pembrolizumab and first-line development plans in the second half of 2023.

Sitravatinib (Potent TAM receptor inhibitor)

•The Company remains on track to provide topline final overall survival results from the global, registration-enabling Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC in the second quarter of 2023.

MRTX1133 (Potent and selective KRASG12D inhibitor)

•In March 2023, the Company began enrolling patients in the Phase 1/2 clinical study with plans for multiple expansion cohorts in pancreatic, colorectal, lung and other tumor types with KRASG12D mutations.

MRTX1719 (MTA cooperative PRMT5 inhibitor)

•The Company presented posters to highlight the mechanism by which MRTX1719 elicits potent and selective synthetic lethality in MTAP deleted tumors as well as the further enhancement of antitumor activity via rational targeted combination strategies at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

•Enrollment is ongoing in the Phase 1/2 clinical study to evaluate MRTX1719, an MTA cooperative PRMT5 inhibitor, in patients with solid tumors harboring MTAP-gene deletions with plans to share initial clinical data from this study in the second half of 2023.

MRTX0902 (Potent SOS1 inhibitor)

•The Company presented preclinical data describing the ability of MRTX0902 to enhance anti-tumor activity and overcome acquired resistance in combination with either adagrasib, a potent and selective KRASG12C inhibitor, or an epidermal growth factor receptor inhibitor (e.g. osimertinib) at the 2023 AACR (Free AACR Whitepaper) Annual Meeting.

•The Company continues to enroll in the Phase 1/2 clinical study evaluating MRTX0902, a selective KRAS signal modifying SOS1 inhibitor, in an escalating dose cohort as a monotherapy and expects to initiate dose escalation cohorts combining MRTX0902 and adagrasib in the second half of 2023.

Recent Corporate Updates

•In May 2023, the Company announced a strategic partnership with Sarah Cannon Research Institute aimed at increasing diversity in clinical study recruitment practices.

First Quarter Financial Results

•Cash, cash equivalents and short-term investments of approximately $0.9 billion as of March 31, 2023.

•Net KRAZATI product revenue for the first quarter 2023 was $6.3 million. There was no product revenue for the same period in 2022.

•License and collaboration revenue for the first quarter 2023 was $0.9 million, compared to $0.7 million for the same period in 2022. Both periods represent clinical supply revenue earned under the agreement with Zai Lab.

•Cost of product revenue for the first quarter 2023 was $0.8 million, of which $0.6 million related to product manufacturing and distribution costs, and royalties incurred on net sales of KRAZATI, and
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$0.2 million represented non-cash amortization expense for our intangible asset. There was no cost of product revenue for the same period in 2022.

•Research and development expenses for the first quarter 2023 were $126.7 million, compared to $131.0 million for the same period in 2022. The decrease in research and development expenses was primarily driven by a reduction in clinical development costs for sitravatinib as enrollment was completed in the SAPPHIRE Phase 3 clinical study in the second quarter of 2022, and lower clinical manufacturing costs to support ongoing clinical studies, partially offset by increases in costs for earlier stage clinical development programs such as MRTX1133, and an increase in salaries and other employee related expense to support portfolio advancement.

•Selling, general and administrative expenses for the first quarter 2023 were $73.5 million, compared to $54.0 million for the same period in 2022. The increase in selling, general and administrative expenses was primarily due to an increase in headcount-related costs, including share-based compensation and salaries, and commercial-related costs to support the marketing and sales of KRAZATI.

•Net loss for the first quarter 2023 was $184.6 million, or $3.18 per share basic and diluted, compared to a net loss of $188.4 million, or $3.40 per share basic and diluted for the same period in 2022.

•Net reduction in cash, cash equivalents and short-term investments for the first quarter was $181.5 million, which included 2022 annual bonus payments and a one-time cash payment of $15 million to Pfizer. The Company expects 2023 net cash burn to annualize within a range of $525 million to $580 million.

Conference Call Information

There will be a conference call on May 9, 2023 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the first quarter and provide corporate updates.

Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 773-305-6853 or international +1 888-394-8218, confirmation code: 8109078.

A replay of the call will be available approximately 2 hours after the event has ended at the same website.