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
2

$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.

On May 9, 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 first quarter ended March 31, 2023 (Press release, Mersana Therapeutics, MAY 9, 2023, View Source [SID1234631280]).

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"We’re excited by the opportunities that lie ahead, with topline data for UPLIFT on the near-term horizon and a comprehensive development plan designed to establish UpRi as a foundational medicine in ovarian cancer," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "Beyond UpRi, we continue to steadfastly focus on ADC innovation as we leverage our proprietary platforms to advance a pipeline of wholly owned assets as well as programs with several collaborators. Thanks to these core strengths and our solid financial position, we believe we have an opportunity to make 2023 a transformational year for Mersana."

Strategic Goals, Recent Developments and Anticipated Milestones

Build UpRi into a Foundational Medicine in Ovarian Cancer

Approaching Topline Data for UPLIFT Registrational Trial: UpRi is a first-in-class NaPi2b-targeting ADC with a novel scaffold-linker-payload that enables high drug-to-antibody ratio and controlled bystander effect.​ Approximately 270 patients with platinum-resistant ovarian cancer were enrolled in UPLIFT. The clinical trial’s primary endpoint is the objective response rate (ORR) in the NaPi2b positive population. The company plans to report topline data from the trial in mid-2023 and, assuming positive data, submit a potential BLA to the U.S. Food and Drug Administration (FDA) for the treatment of patients with platinum-resistant ovarian cancer around the end of 2023.

Progressing Enrollment in UP-NEXT Trial: Patient dosing is ongoing in UP-NEXT, the company’s Phase 3 clinical trial of UpRi as monotherapy maintenance following treatment with platinum doublets in NaPi2b-positive recurrent platinum-sensitive ovarian cancer. If the data from this trial are positive, UP-NEXT could serve as a post-approval confirmatory trial in the United States, support potential approvals outside of the United States and support UpRi’s expansion into earlier lines of therapy.

Advancing Dose Expansion Portion of UPGRADE-A Trial: In the first quarter of 2023, Mersana completed dose escalation and initiated the dose expansion portion of UPGRADE-A, a Phase 1 clinical trial of UpRi in combination with carboplatin. The company expects to present initial interim data from the trial in the second half of 2023.
Build a Pipeline of Highly Impactful Cancer Medicines

Continuing Dose Escalation of XMT-1660 in Phase 1 Trial: XMT-1660 is a B7-H4-directed Dolasynthen ADC designed with a precise, target-optimized drug-to-antibody ratio (DAR 6) and Mersana’s DolaLock microtubule inhibitor payload with controlled bystander effect. The company expects to complete the dose escalation portion of the company’s multicenter Phase 1 clinical trial investigating XMT-1660 in patients with breast, endometrial and ovarian cancers in 2023.

XMT-2056 Phase 1 Trial: XMT-2056 is a systemically administered Immunosynthen STING agonist ADC (DAR 8) that is designed to target a novel HER2 epitope and locally activate STING signaling in both tumor-resident immune cells and in tumor cells. In March 2023, the FDA placed Mersana’s multicenter Phase 1 trial of XMT-2056 on clinical hold following the company’s communication to FDA that it was voluntarily suspending the trial due to a Grade 5 serious adverse event (SAE) that was deemed to be related to XMT-2056. Mersana continues to investigate the SAE and to evaluate next steps related to the development of XMT-2056.
First Quarter 2023 Financial Results

Net cash used in operating activities for the first quarter of 2023 was $29.0 million.

Cash, cash equivalents and marketable securities as of March 31, 2023 were $273.9 million, compared to cash and cash equivalents of $280.7 million as of December 31, 2022. Mersana expects that its available funds will be sufficient to support its operating plan commitments into the second half of 2024.
Collaboration revenue for the first quarter of 2023 was $7.8 million, compared to $2.0 million for the same period in 2022. The year-over-year increase was primarily related to Mersana’s collaboration agreements with Merck KGaA, Darmstadt, Germany and Asana Biosciences.

Research and development (R&D) expenses for the first quarter of 2023 were $47.3 million, compared to $35.8 million for the same period in 2022. Included in first quarter 2023 R&D expenses were $3.3 million in non-cash stock-based compensation expenses. The year-over-year increase in R&D expenses was primarily related to higher manufacturing and clinical costs related to UpRi and an increase in headcount.
General and administrative (G&A) expenses for the first quarter of 2023 were $18.3 million, compared to $12.8 million during the same period in 2022. Included in first quarter 2023 G&A expenses were $3.1 million in non-cash stock-based compensation expenses. The year-over-year increase in G&A expenses was primarily related to increases in medical affairs, pre-commercial activities and headcount.

Net loss for the first quarter of 2023 was $56.2 million, or $0.52 per share, compared to a net loss of $47.3 million, or $0.59 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 first quarter 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 May 9, 2023 MannKind Corporation (Nasdaq: MNKD) reported financial results for the quarter ended March 31, 2023 (Press release, Mannkind, MAY 9, 2023, View Source [SID1234631279]).

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"Demand for Tyvaso DPI has been very strong, which resulted in $23 million in revenues in the first quarter of 2023," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "I’m excited about our inhaled platform and orphan lung pipeline as we get ready to launch our Phase 2/3 inhaled clofazimine trial for patients in the second half of 2023."

Revenue Highlights

Three Months
Ended March 31,
2023 2022 $ Change % Change
(Dollars in thousands)
Net revenue – Afrezza $ 12,423 $ 9,826 $ 2,597 26 %
Net revenue – V-Go 5,139 — $ 5,139 *
Revenue – collaborations and services 11,386 2,166 $ 9,220 426 %
Royalties – collaborations 11,678 — $ 11,678 *
Total revenues $ 40,626 $ 11,992 $ 28,634 239 %
___________________
* Not meaningful

Afrezza net revenue for the first quarter of 2023 increased compared to the same period in 2022 as a result of higher product demand, higher price (including a more favorable gross-to-net adjustment) and a more favorable cartridge mix. V-Go was acquired in the second quarter of 2022. The increase in collaborations and services revenue reflected that the commercial manufacturing of Tyvaso DPI had not yet commenced in the prior period. Royalties related to Tyvaso DPI, launched in the second quarter of 2022 by United Therapeutics ("UT"), continued to grow based on strong patient demand.

Commercial product gross margin in the first quarter of 2023 was 69% compared to 77% for the same period in 2022 primarily related to the addition of V-Go in the second quarter of 2022 which had a lower gross margin than Afrezza.

Cost of revenue – collaborations and services for the first quarter of 2023 was $10.7 million compared to $8.7 million for the same period in 2022, an increase of $2.0 million, due to an increase in manufacturing activities for Tyvaso DPI.

Research and development expenses for the first quarter of 2023 were $5.6 million compared to $3.5 million for the same period in 2022. The $2.1 million increase was primarily attributed to costs incurred to develop our product pipeline, including MNKD-101 (inhaled clofazimine) and the Afrezza pediatrics clinical study (INHALE-1).

Selling expenses for the first quarter of 2023 were $13.3 million compared to $12.7 million for the same period in 2022. The $0.6 million increase was primarily due to V-Go promotional efforts and increased headcount after the acquisition in the second quarter of 2022 as well as an increase in Afrezza promotional activities, partially offset by the termination of an Afrezza pilot promotional effort targeting primary care physicians which ended in the third quarter of 2022.

General and administrative expenses for the first quarter of 2023 were $10.5 million compared to $7.9 million for the same period in 2022. The $2.6 million increase was primarily attributable to higher stock-based compensation, increased headcount, and higher professional fees.

Interest expense on financing liability was $2.4 million for the first quarter of 2023 and remained consistent with the same period in 2022.

Interest expense on notes was $2.8 million in the first quarter of 2023 and remained consistent with the same period in 2022 due to fixed interest rates and no changes in debt balances.

Cash, cash equivalents and investments as of March 31, 2023 were $166.6 million.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.

On May 9, 2023 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and announced financial results for the quarter ended March 31, 2023 (Press release, MacroGenics, MAY 9, 2023, View Source [SID1234631278]).

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"The recent U.S. Food and Drug Administration (FDA) approval of Incyte’s ZYNYZ (retifanlimab-dlwr) represents the third U.S. marketing clearance of a product originating from MacroGenics’ pipeline of proprietary or partnered product candidates. We are delighted that the approval of ZYNYZ provides an additional option for treating patients with Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "With the approval of both ZYNYZ and TZIELD (teplizumab-mzwv) by our partners, MacroGenics remains eligible to receive more than $1 billion in milestone payments related to the continued advancement and successful commercialization of these two products. Over the past nine months, these and other programs have allowed us to generate $270 million in non-dilutive capital, extending our cash runway through 2025."

Updates on Proprietary Investigational Programs

Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below.

Vobramitamab duocarmazine (vobra duo) is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumor types and a member of the B7 family of molecules involved in immune regulation.
MacroGenics initiated the Phase 2 portion of the TAMARACK study of vobra duo in patients with mCRPC in late 2022. This study is designed to evaluate vobra duo at two different doses, 2.0 mg/kg or 2.7 mg/kg every four weeks, in two experimental arms comprising a total of 100 patients. Regulatory approval of a modified protocol, primarily reflecting removal of a control arm, has been obtained in the U.S. and all countries targeted for study enrollment in the E.U. MacroGenics anticipates commencement of enrollment under the revised protocol beginning in the second quarter of 2023 and expects to provide a clinical update in 2024.
MacroGenics continues to enroll a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors.
Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule. The Company presented encouraging preliminary clinical results from a single arm, dose-expansion study of lorigerlimab in patients with advanced solid tumors in a poster session at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February 2023. Based on the strength of the mCRPC data presented, MacroGenics plans to commence enrollment of a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel in second-line, chemotherapy-naïve mCRPC patients in the second half of 2023. A total of 150 patients are planned to be randomized 2:1. The current study design includes a primary study endpoint of radiographic progression-free survival (rPFS).
MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing through a longer half-life. MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes.
Enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3. In April 2023, results from a Phase 2 investigator-sponsored study at the Johns Hopkins Kimmel Cancer Center was published in Nature Medicine. In the clinical study, 32 men with high-risk or very high-risk prostate cancer who were scheduled for prostate cancer surgery were treated with six weekly infusions of enoblituzumab prior to surgery and were followed for an average of 30 months thereafter. Twenty-one patients (66%) had an undetectable prostate-specific antigen (PSA) level 12 months following surgery, suggesting to the authors that there was no sign of residual disease. Additionally, the investigators reported the drug was well-tolerated overall; no patients had any surgical delays or medical complications during or after the operation.
Other Corporate Updates

Sale of TZIELD royalty interest. As announced in March 2023, MacroGenics received a $100 million upfront payment from a wholly-owned subsidiary of DRI Healthcare Trust (DRI) for the sale to DRI of its single-digit royalty on global net sales of TZIELD, while retaining the right to receive a 50% share of the royalty on global net sales above a certain annual threshold. Sanofi, S.A. (Sanofi)’s acquisitions of both Provention Bio and DRI’s royalty interest in TZIELD in April 2023 have not changed MacroGenics’ economic interests, and MacroGenics is eligible to receive from Sanofi a total of up to $430 million in milestone payments, including $105 million upon the achievement of certain regulatory approval milestones, $225 million upon the achievement of certain sales milestones and $100 million in potential payments that Sanofi assumed from DRI.
ZYNYZ approval. As announced in March 2023, the FDA approved ZYNYZ, a humanized monoclonal antibody targeting PD-1, for the treatment of adults with metastatic or recurrent locally advanced MCC. Incyte continues to conduct global registrational studies of retifanlimab across multiple indications, including lung, anal and endometrial cancer. This molecule was initially developed by MacroGenics and licensed by Incyte in October 2017, pursuant to an exclusive global collaboration and license agreement that includes the following provisions:

MacroGenics received a $15 million milestone payment from Incyte based on the approval of ZYNYZ in MCC and is eligible to receive up to a total of $320 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones from Incyte.
MacroGenics is eligible to receive tiered royalties of 15% to 24% from Incyte on any global net sales of the product.
MacroGenics will manufacture a portion of Incyte’s global commercial supply of retifanlimab.
First Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2023, were $241.7 million, compared to $154.3 million as of December 31, 2022. This cash balance did not include a $30 million payment received after March 31, 2023 related to the TZIELD approval milestone.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $24.5 million for the quarter ended March 31, 2023, compared to total revenue of $11.1 million for the quarter ended March 31, 2022.
R&D Expenses: Research and development expenses were $45.9 million for the quarter ended March 31, 2023, compared to $61.4 million for the quarter ended March 31, 2022. The decrease was primarily related to decreased vobramitamab duocarmazine development costs and decreased costs related to discontinued studies. These decreases were partially offset by increased expenses related to discovery projects and preclinical molecules, and increased clinical expenses related to lorigerlimab.
SG&A Expenses: Selling, general and administrative expenses were $13.5 million for the quarter ended March 31, 2023, compared to $16.3 million for the quarter ended March 31, 2022. The decrease was primarily related to decreased legal and consulting expenses.
Net Loss: Net loss was $38.0 million for the quarter ended March 31, 2023, compared to net loss of $66.4 million for the quarter ended March 31, 2022.
Shares Outstanding: Shares of common stock outstanding as of March 31, 2023 were 61,838,565.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $241.7 million as of March 31, 2023, plus projected and anticipated future payments from partners and product revenues should extend its cash runway through 2025. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the planned Phase 2 study of lorigerlimab in mCRPC as well as MacroGenics’ other ongoing clinical and preclinical studies.
Conference Call Information

To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.

On May 9, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR artificial intelligence ("AI") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported operational highlights and financial results for the first quarter ended March 31, 2023 (Press release, Lantern Pharma, MAY 9, 2023, View Source [SID1234631277]).

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"This quarter we continued to execute our mission of transforming the oncology drug discovery and development process using our industry-leading AI platform RADR. We are deploying AI at a massive scale – think millions of simultaneous instances of competing and synergistic algorithms – to determine drug and cancer correlations that would be far too complex and time-consuming for any team of humans to fully analyze, let alone replicate. AI is enabling us to understand and predict drug-cancer interactions, create new drug programs, and discover cancer biology insights at a cost and timeline that was unimaginable in the near past, and Lantern Pharma is at the forefront of this transformative approach," stated Panna Sharma Lantern’s CEO and President.

"As part of our team’s relentless efforts to advance RADR, we recently developed top-ranked and highly accurate algorithms to predict any compound’s blood-brain-barrier (BBB) permeability, which is one of the major obstacles to developing effective brain cancer drugs. Continued innovations like this will position us for additional high-value biopharma collaborations and will also advance our own AI-powered pipeline of brain and CNS cancer drug candidates," continued Sharma.

"In addition to our pioneering work transforming oncology drug discovery and development with AI, we continue to progress our drug candidates into and through their clinical development. In March, we announced the dosing of the first patient in our Phase 2 Harmonic clinical trial for never-smokers with NSCLC and anticipate enrollment will accelerate as we expand our sites across the US. Our team has been unrelenting in their work to advance both LP-184 and LP-284 into first-in-human clinical trials this year. This week, we anticipate submitting our IND application to the FDA for LP-184’s first-in-human trial for advanced solid tumors and brain cancers. On average, we have been able to advance our newly developed drug programs from initial AI insights to first-in-human clinical trials in 2-3 years and at a cost of around $1.0-2.0 million USD per program – both metrics that are completely unheard of in oncology drug discovery," stated Sharma.

Highlights of AI-Powered Pipeline:

● LP-184 – Anticipate submitting the investigational new drug (IND) application for LP-184 to the US Food and Drug Administration (FDA) this week. Lantern is targeting to launch a Phase 1A basket trial for LP-184 in mid-2023 for multiple recurrent brain cancers and solid tumors with unmet clinical needs. Indications for the trial are anticipated to include advanced high-grade gliomas/glioblastoma (GBM), brain metastases, pancreatic cancer, and other solid tumor types with DNA damage response deficiencies. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $11.0-13.0 billion, consisting of $5.0-6.0 billion for CNS cancers and $6.0-7.0 billion for solid tumors.

● LP-300 – Recently dosed the first patient in the Phase 2 Harmonic clinical trial that is assessing the effect of LP-300 in combination with standard-of-care chemotherapy in never-smoker patients with relapsed non-small cell lung cancer (NSCLC). Across the five Harmonic clinical trial sites in the US, over a dozen additional potential patients have been pre-screened and are being monitored for possible enrollment. Multiple additional trial sites across the US are expected to be activated by mid-2023 to bolster patient recruitment and enrollment. In the US, there are approximately 20,000-40,000 never-smokers with NSCLC diagnosed annually, representing an estimated annual market potential of $1.5-2.0 billion. Additional information on the Harmonic trial can be found at the Harmonic website and the clinicaltrials.gov website.

● LP-284 – Completion of the LP-284 IND enabling studies is anticipated for mid-2023. The first-in-human Phase 1 clinical trial launch is targeted for the second half of 2023 for B-cell non-Hodgkin’s lymphomas (NHL), where LP-284 has shown nanomolar potency across multiple in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other NHL cancer subtypes. Nearly all MCL patients relapse from the current MCL standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic options for these patients. In the US and Europe, MCL and DHL are diagnosed in approximately 9,000 patients each year and have an estimated annual market potential of $1.2 billion.

Formation of Starlight Therapeutics:

● Lantern recently formed a wholly-owned subsidiary, Starlight Therapeutics Inc. ("Starlight"), for the clinical development of drug candidate LP-184’s central nervous system (CNS) and brain cancer indications – including glioblastoma (GBM), brain metastases (brain mets.), and several rare pediatric CNS cancers. Starlight will refer to the molecule LP-184, as it is developed in CNS indications, as "STAR-001".

● The clinical development of STAR-001 in CNS cancers beyond the Phase 1A trial will be conducted exclusively by Starlight. Following the launch of Starlight, Lantern will continue to advance LP-184’s preclinical and clinical development for non-CNS indications (including pancreatic cancer and other solid tumors) and will also provide RADR AI-driven bioinformatic and computational biology support to Starlight.

RADR Platform Growth and Development:

● Developed top-ranked AI algorithms to predict any compound’s blood-brain barrier (BBB) permeability. The AI algorithms, which have been fully integrated into RADR, have 89-92% accuracy, have been optimized to rapidly generate predictions in approximately one minute, and are highly scalable to screen thousands of compounds simultaneously. The BBB prevents an estimated 98% of drugs from entering the brain and is a major limitation to developing drugs for brain and CNS cancers. Lantern’s AI-driven approach offers a rapid and highly-accurate alternative for predicting a drug’s BBB permeability compared to conventional wet lab approaches.

● Breakthrough RADR advancements were presented at the AACR (Free AACR Whitepaper) annual meeting in collaboration with Actuate Therapeutics. The AACR (Free AACR Whitepaper) poster presented data demonstrating that RADR algorithms had an 88% accuracy in predicting responders and non-responders in Actuate Therapeutics’ Phase 1 clinical trial for their drug candidate, elraglusib. These patient response predictions are anticipated to be leveraged for patient selection in Actuate’s upcoming late-stage clinical trials for elraglusib.

● Lantern recently established a new RADR and AI-driven collaboration with TTC Oncology to enhance the development of TTC’s Phase 2 ready drug candidate TTC-352. TTC-352 is a novel, first- and best-in-class selective human estrogen receptor (ER) partial agonist (ShERPA) for the treatment of patients with metastatic ER+ breast cancer. The initial aims of the collaboration will be to identify biomarker or gene signatures to power potential patient selection for an upcoming TTC-352 Phase 2 clinical trial and to discover additional treatment indications for TTC-352. Under the terms of the collaboration, Lantern is receiving an exclusive right to license TTC-352, including any collaboration intellectual property (IP), during an exclusive option period.

Other Operational Highlights

● Lantern received a notice of allowance from the United States Patent and Trademark Office (USPTO) for the composition of matter patent, no. 17/192,838, covering the molecule LP-284, including claims covering the new molecular entity. Lantern expects the resulting LP-284 patent will be Orange Book-listable with an anticipated expiration of early 2039.

● At the 2023 AACR (Free AACR Whitepaper) annual meeting, Lantern scientists presented new preclinical data highlighting how LP-184’s unique synthetic lethality mechanism of action is being leveraged as a single agent as well as in combination with the PARP inhibitor (PARPi), Olaparib, for the potential treatment of multiple cancer types that are deficient in DNA damage response (DDR). The poster also highlighted additional results demonstrating that as a single agent, LP-184 has significantly higher potency than Olaparib across multiple preclinical cancer models deficient in DDR including pancreatic, prostate, and non-small cell lung cancer models.

First Quarter 2023 Financial Overview:

● Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $51.5 million as of March 31, 2023, compared to approximately $55.2 million as of December 31, 2022. The quarterly cash burn rate continues to reflect our capital-efficient, collaborator-centered business model.

● R&D Expenses: Research and development expenses were approximately $2.6 million for the quarter ended March 31, 2023, compared to approximately $2.7 million for the quarter ended March 31, 2022. Research and development expenses for the quarter ended March 31, 2022 included a non-recurring escrow release payment of approximately $459,000.

● G&A Expenses: General and administrative expenses were approximately $1.7 million for the quarter ended March 31, 2023, compared to approximately $1.4 million for the quarter ended March 31, 2022.

● Net Loss: Net loss was approximately $3.9 million (or $0.36 per share) for the quarter ended March 31, 2023, compared to a net loss of approximately $4.1 million (or $0.38 per share) for the quarter ended March 31, 2022.

Earnings Call and Webinar Details:

Lantern will host its first quarter 2023 earnings call and webinar today, Tuesday, May 9, 2023 at 4:30 p.m. ET.

● View Source
● Related presentation materials will be accessible at: View Source
● A replay of the first quarter earnings call and webinar will be available at View Source.