On August 8, 2024 Eli Lilly and Company (NYSE: LLY) reported its financial results for the second quarter of 2024 (Press release, Eli Lilly, AUG 8, 2024, View Source [SID1234645595]).

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"Mounjaro, Zepbound and Verzenio led our strong financial performance in the second quarter as we advanced our manufacturing expansion agenda, and it is equally exciting to see the growth around the world of our medicines for cancer, neurological disorders and autoimmune diseases," said David A. Ricks, Lilly’s chair and CEO. "We also recently received approval of Kisunla to help people with Alzheimer’s disease, a moment that was decades in the making. Lilly’s performance and progress in Alzheimer’s, metabolic disorders and many other serious diseases highlight the tenacity, focus and capability of our scientists, clinicians, engineers, customer teams and collaborators."

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

U.S. Food and Drug Administration (FDA) approval of Kisunla (donanemab-azbt) for the treatment of Alzheimer’s disease;
Approval of Jaypirca in Japan for people with relapsed or refractory mantle cell lymphoma who are resistant or intolerant to other Bruton tyrosine kinase inhibitors;
Submission of tirzepatide in the U.S. and EU for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity;
Submission of mirikizumab in Japan for the treatment of moderately to severely active Crohn’s disease;
Positive topline results from the SUMMIT Phase 3 clinical trial evaluating tirzepatide in adults with heart failure with preserved ejection fraction and obesity;
Positive topline results from the QWINT-2 and QWINT-4 Phase 3 clinical trials that showed once-a-week dosing of insulin efsitora alfa in adults with type 2 diabetes delivers A1C reduction and safety profile consistent with daily insulin;
The announcement of an agreement for Lilly to acquire Morphic Holding, Inc. to expand Lilly’s immunology pipeline with oral integrin therapies for treatment of serious chronic diseases;
The commitment of an additional $5.3 billion manufacturing investment in the company’s newest Indiana site to boost API production for tirzepatide and pipeline medicines;
The issuance of an open letter informing the public about potentially serious risks posed by the proliferation of counterfeit, fake, compounded, and other unsafe or untested versions of the company’s FDA-approved tirzepatide medications and about the appropriate use of the company’s authentic medicines; and
Announcements regarding changes to the company’s executive leadership team.
For information on important public announcements, visit the news section of Lilly’s website.

Financial Results

$ in millions, except

per share data

Second Quarter

2024

2023

% Change

Revenue

$ 11,302.8

$ 8,312.1

36 %

Net income – Reported

2,967.0

1,763.2

68 %

Earnings per share – Reported

3.28

1.95

68 %

Net income – Non-GAAP

3,541.2

1,904.4

86 %

Earnings per share – Non-GAAP

3.92

2.11

86 %

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Second-Quarter Reported Results
In Q2 2024, worldwide revenue was $11.30 billion, an increase of 36% compared with Q2 2023, driven by a 27% increase in volume and a 10% increase due to higher realized prices, partially offset by a 1% decrease from the unfavorable impact of foreign exchange rates. The volume increase was primarily driven by growth from Mounjaro, Zepbound, Verzenio, Taltz and Jardiance, partially offset by the sale of rights for Baqsimi in Q2 2023 and declines in Trulicity. Excluding $579.0 million of revenue from the sale of rights for Baqsimi in Q2 2023, revenue in Q2 2024 increased by 46%, and worldwide volume increased by 37%. Excluding the sale of rights for Baqsimi, non-incretin revenue increased 17% worldwide and 25% in the U.S.

Strong performance by the company’s incretin medicines continued, as production increases resulted in improved channel dynamics and stocking levels in the U.S., contributing to sales growth during the quarter. While supply and demand have come into better balance, expected increases in demand may result in periodic supply tightness for certain presentations and dose levels. In the U.S., the company plans to launch Zepbound 2.5 mg and 5 mg single-dose vials in the coming weeks.

Higher realized prices were primarily driven by Mounjaro in the U.S., which saw net price positively impacted by access and savings card dynamics compared with Q2 2023. In the second half of 2024, these savings card dynamics should have a minimal impact on realized price comparisons to base periods, as the $25 non-covered benefit expired on June 30, 2023. New Products(i) revenue grew by $3.46 billion to $4.46 billion in Q2 2024, led by Mounjaro and Zepbound. Growth Products(ii) revenue increased 3% to $5.05 billion in Q2 2024 as growth led by Verzenio, Taltz, and Jardiance was largely offset by lower Trulicity sales.

(i) Lilly defines New Products as select products launched since 2022, which currently consist of Ebglyss, Jaypirca, Mounjaro, Omvoh and Zepbound.

(ii) Lilly defines Growth Products as select products launched prior to 2022, which currently consist of Cyramza, Emgality, Jardiance, Olumiant, Retevmo, Taltz, Trulicity, Tyvyt and Verzenio

Revenue in the U.S. increased 42% to $7.84 billion, driven by a 27% increase in volume and a 15% increase in realized prices. The increase in U.S. volume was driven by Zepbound, Mounjaro and Verzenio, partially offset by the sale of rights for Baqsimi in Q2 2023 and declines in Trulicity. The higher realized prices in the U.S. were primarily driven by Mounjaro. The company fulfilled the majority of prior incretin wholesaler backorders during Q2 2024, improving both wholesaler stocking levels and overall product availability for patients in the U.S. Q2 2024 Mounjaro and Zepbound sales in the U.S. were positively impacted by channel stocking that the company estimates totaled high teens to mid-20s as a percent of U.S. sales.

Revenue outside the U.S. increased 25% to $3.47 billion, driven by a 27% increase in volume, partially offset by a 3% decrease due to the unfavorable impact of foreign exchange rates. The increase in volume outside the U.S. was primarily driven by the launch of Mounjaro KwikPen in various markets.

Gross margin increased 40% to $9.13 billion in Q2 2024. Gross margin as a percent of revenue was 80.8%, an increase of 2.5 percentage points. The increase in gross margin percent was primarily driven by favorable product mix and higher realized prices, partially offset by higher production costs.

In Q2 2024, research and development expenses increased 15% to $2.71 billion, or 24% of revenue, driven by continued investments in the company’s portfolio and its people.

Marketing, selling and administrative expenses increased 10% to $2.12 billion in Q2 2024, primarily driven by investments in the company’s launches and its people.

In Q2 2024, the company recognized acquired in-process research and development (IPR&D) charges of $154.3 million compared with $97.1 million in Q2 2023.

Asset impairment, restructuring and other special charges were $435.0 million in Q2 2024, which was related to anticipated litigation payments. There were no asset impairment, restructuring and other special charges in Q2 2023.

Other income (expense) was expense of $197.6 million in Q2 2024, compared to expense of $36.8 million in Q2 2023. The increase in expense was primarily driven by larger net losses on investments in equity securities in Q2 2024 and higher net interest expenses.

The effective tax rate was 15.6% in both Q2 2024 and Q2 2023. The Q2 2024 tax rate reflects a mix of earnings in higher tax jurisdictions, while the Q2 2023 rate reflects the impact of earnings from the sale of rights for Baqsimi.

In Q2 2024, net income and earnings per share (EPS) were $2.97 billion and $3.28, respectively, compared with net income of $1.76 billion and EPS of $1.95 in Q2 2023. EPS in Q2 2024 included $0.14 of acquired IPR&D charges compared with $0.09 in Q2 2023.

Second-Quarter Non-GAAP Measures
On a non-GAAP basis, Q2 2024 gross margin increased 40% to $9.27 billion. Gross margin as a percent of revenue was 82.0%, an increase of 2.2 percentage points. The increase in gross margin percent was primarily driven by favorable product mix and higher realized prices, partially offset by higher production costs.

The effective tax rate on a non-GAAP basis was 16.5% in Q2 2024 compared with 16.1% in Q2 2023. The Q2 2024 tax rate reflects a mix of earnings in higher tax jurisdictions, while the Q2 2023 rate reflects the impact of earnings from the sale of rights for Baqsimi.

On a non-GAAP basis, Q2 2024 net income and EPS were $3.54 billion and $3.92, respectively, compared with net income of $1.90 billion and EPS of $2.11 in Q2 2023. EPS in Q2 2024 included $0.14 of acquired IPR&D charges compared with $0.09 in Q2 2023.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Second Quarter

2024

2023

% Change

Earnings per share (reported)

$ 3.28

$ 1.95

68 %

Asset impairment, restructuring and other special
charges

.38

—

Net losses on investments in equity securities

.14

.05

Amortization of intangible assets

.12

.11

Earnings per share (non-GAAP)

$ 3.92

$ 2.11

86 %

Numbers may not add due to rounding.

Acquired IPR&D

.14

.09

56 %

Selected Revenue Highlights

(Dollars in millions)

Second Quarter

Year-to-Date

Selected Products

2024

2023

% Change

2024

2023

% Change

Mounjaro

$ 3,090.8

$ 979.7

NM

$ 4,897.4

$ 1,548.2

NM

Trulicity

1,245.6

1,812.5

(31) %

2,701.9

3,789.6

(29) %

Verzenio

1,331.9

926.8

44 %

2,382.2

1,677.7

42 %

Zepbound

1,243.2

—

NM

1,760.6

—

NM

Jardiance(a)

769.6

668.3

15 %

1,456.1

1,245.8

17 %

Taltz

824.7

703.9

17 %

1,428.8

1,230.8

16 %

Humalog(b)

631.6

440.4

43 %

1,170.3

901.4

30 %

Total Revenue

11,302.8

8,312.1

36 %

20,070.8

15,272.1

31 %

(a) Jardiance includes Glyxambi, Synjardy and Trijardy XR

(b) Humalog includes Insulin Lispro

NM – not meaningful

Mounjaro
For Q2 2024, worldwide Mounjaro revenue was $3.09 billion compared with $979.7 million in Q2 2023. U.S. revenue was $2.41 billion compared with $915.7 million in Q2 2023, reflecting continued strong demand, improved channel dynamics, and higher realized prices due to savings card dynamics. In the second half of 2024, these savings card dynamics should have a minimal impact on realized price comparisons to base periods, as the $25 non-covered benefit expired on June 30, 2023. Revenue outside the U.S. increased to $677.2 million compared with $64.0 million in Q2 2023, primarily driven by volume associated with the launch of Mounjaro KwikPen in various markets.

Trulicity
For Q2 2024, worldwide Trulicity revenue decreased 31% compared with Q2 2023 to $1.25 billion. U.S. revenue decreased 36% to $876.7 million, driven by decreased sales volume primarily due to competitive dynamics and supply constraints, partially offset by improved wholesaler stocking levels on certain doses. Revenue outside the U.S. decreased 16% to $368.9 million, primarily driven by decreased volume. In addition to the factors affecting U.S. volume, international markets continue to be impacted by actions Lilly has taken to manage demand amid tight supply, including measures to minimize the impact on existing patients by communicating with healthcare practitioners to not start new patients on Trulicity.

Verzenio
For Q2 2024, worldwide Verzenio revenue increased 44% compared with Q2 2023 to $1.33 billion. U.S. revenue was $861.4 million, an increase of 46%, primarily driven by increased demand. Revenue outside the U.S. was $470.5 million, an increase of 39%, driven by increased demand, partially offset by the unfavorable impact of foreign exchange rates.

Zepbound
For Q2 2024, U.S. Zepbound revenue was $1.24 billion. Zepbound launched in the U.S. for the treatment of adult patients with obesity or overweight with weight-related comorbidities in November 2023.

Jardiance
For Q2 2024, the company’s worldwide Jardiance revenue increased 15% compared with Q2 2023 to $769.6 million. U.S. revenue was $428.9 million, an increase of 11%, driven by increased demand. Revenue outside the U.S. was $340.7 million, an increase of 21%, driven by increased volume.

Jardiance is part of the company’s alliance with Boehringer Ingelheim. Lilly reports as revenue royalties received on net sales of Jardiance.

Taltz
For Q2 2024, worldwide Taltz revenue increased 17% compared with Q2 2023 to $824.7 million. U.S. revenue increased 14% to $539.4 million, driven by increased demand and, to a lesser extent, channel dynamics. Revenue outside the U.S. increased 23% to $285.3 million, driven by increased demand.

Humalog
For Q2 2024, worldwide Humalog revenue increased 43% compared with Q2 2023 to $631.6 million. U.S. revenue was $434.7 million, an increase of 89%, driven by higher realized prices primarily due to changes to estimates for rebates and discounts, segment mix and increased demand. Revenue outside the U.S. was $196.9 million, a decrease of 7%, driven by decreased volume, partially offset by higher realized prices.

2024 Financial Guidance
2024 full-year revenue guidance increased by $3.0 billion to the range of $45.4 billion to $46.6 billion, primarily driven by the strong performance of Mounjaro and Zepbound, as well as the company’s non-incretin medicines. Additionally, the company has improved clarity into the timing and pace of the company’s production expansions and planned Mounjaro launches outside the U.S. In Q2 2024, the company achieved a number of supply-related milestones and has increased confidence regarding production expectations for the rest of the year.

The ratio of (Gross Margin – OPEX) / Revenue, where OPEX is defined as the sum of research and development expenses and marketing, selling and administrative expenses, is now expected to be in the range of 36% to 38% on a reported basis and 37% to 39% on a non-GAAP basis. Both ratios reflect the $3.0 billion increase in revenue guidance.

Guidance on a reported basis now includes asset impairment, restructuring and other special charges of $435 million to reflect the Q2 2024 charge, which was associated with anticipated litigation payments.

Other income (expense) guidance is now expected to be a range of ($525) to ($425) million of expense on a reported basis and ($400) to ($300) million of expense on a non-GAAP basis, both reflecting lower expected net interest expense. The reported guidance also reflects net losses on investments in equity securities through Q2 2024.

Tax rate guidance is now expected to be approximately 15% on both a reported and non-GAAP basis, driven by changes in the company’s forecasted mix of earnings in higher tax jurisdictions.

Based on these changes, EPS guidance increased to the ranges of $15.10 to $15.60 on a reported basis and $16.10 to $16.60 on a non-GAAP basis. The company’s 2024 financial guidance reflects adjustments shown in the reconciliation table below.

2024

Guidance(1)

Earnings per share (reported)

$15.10 to $15.60

Amortization of intangible assets

.49

Asset impairment, restructuring, and other special charges

.38

Net losses on investments in equity securities

.12

Earnings per share (non-GAAP)

$16.10 to $16.60

Numbers may not add due to rounding

(1) Reported and Non-GAAP EPS guidance both include $0.24 of Acquired IPR&D charges incurred through Q2 2024.

The following table summarizes the company’s 2024 financial guidance:

2024 Guidance(1)

Prior

Updated(3)

Revenue

$42.4 to $43.6 billion

$45.4 to $46.6 billion

(Gross Margin – OPEX(2)) / Revenue:

(reported)

32% to 34%

36% to 38%

(non-GAAP)

33% to 35%

37% to 39%

Other Income/(Expense) (reported)

($500) to ($400) million

($525) to ($425) million

Other Income/(Expense) (non-GAAP)

($500) to ($400) million

($400) to ($300) million

Tax Rate

Approx. 14%

Approx. 15%

Earnings per Share (reported)

$13.05 to $13.55

$15.10 to $15.60

Earnings per Share (non-GAAP)

$13.50 to $14.00

$16.10 to $16.60

(1) Non-GAAP guidance reflects adjustments presented in the earnings per share reconciliation table above.

(2) OPEX is defined as the sum of research and development expenses and marketing, selling and administrative expenses.

(3) Guidance includes Acquired IPR&D charges through Q2 2024 of $264.8 million or $0.24 on a per share basis. Guidance does not include Acquired IPR&D either incurred, or expected to be incurred, after Q2 2024.

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q2 2024 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website.

On August 8, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, reported operational highlights and financial results for the second quarter 2024, ending June 30, 2024 (Press release, Lantern Pharma, AUG 8, 2024, View Source [SID1234645612]).

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"The team at Lantern Pharma is making solid, thoughtful and disciplined progress in our clinical trials and in our collaborative research and AI efforts. This past quarter saw a significant milestone where our clinical trials are getting to the point of having initial patient data that we can share, including our unique Harmonic clinical trial for never smokers with lung cancer. We continue to also improve the functionality and abilities of our AI platform, RADR, to guide the next phase of our therapeutic programs which will be heavily marked by trials with combination regimens, and ADC development." said Panna Sharma, President and CEO of Lantern Pharma.

Highlights of AI-Powered Pipeline:

Ø LP-300: The Harmonic Phase 2 Clinical Trial – Preliminary results at the completion of the 7-patient lead-in part of the Harmonic study demonstrated predictable safety profiles that are consistent with the chemotherapy regimen alone and seemed to demonstrate clinical benefit for 6 out of the 7 patients – an 86% clinical benefit rate (CBR). No patients experienced dose limiting toxicities, and no discontinuations were observed due to treatment related toxicity. Six patients experienced clinical benefit from the combination of LP-300 and chemotherapy while 1 patient experienced progressive disease. The clinical benefit rate is 86% for this group with an objective response rate (ORR) of 43%. Of the 6 patients experiencing clinical benefit – 3 patients showed partial responses with an average tumor size reduction of 51% and 3 patients have stable disease with an average tumor size reduction of 13%. Encouraging preliminary efficacy results were observed regardless of prior tyrosine kinase inhibitor (TKI) treatment(s), demographics, and metastatic disease sites. In the initial set of patients, those having low to intermediate TMB (tumor mutation burden) were found to be responsive to LP-300 + chemotherapy.

The phase 2 Harmonic clinical trial sites in the US, and certain sites in Japan are screening for eligible patients and we expect the pace of enrollment to increase in the coming months. This past quarter we also initiated IRB approvals and site initiation visits in Asia. The expansion of the Phase 2 clinical trial in Japan and Taiwan is expected to accelerate the collection of patient and response data that are needed for the next-stage of development of LP-300, a therapeutic for the treatment of relapsed and inoperable primary adenocarcinoma of the lung given in combination with chemotherapy. Additionally, it may also bring a needed therapeutic option for never-smokers with NSCLC in Japan and Taiwan, where one-third or more of all lung cancer diagnoses are made among those who have never smoked. Dr. Yashushi Goto, a physician and researcher focused on lung cancer at the National Cancer Center of Japan, will be leading the phase 2 trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States. Lantern believes that this improves the positioning for drug-candidate LP-300 to develop collaborative and co-development partnerships with global biopharma companies with a primary focus in serving the Asian markets.

The Harmonic trial is assessing the effect of LP-300 in combination with standard-of-care chemotherapy in never-smoker patients with relapsed NSCLC where they have failed TKI therapies. Globally, never-smokers with NSCLC are a growing population of patients and do not respond well to PD-1/PD-L1-based therapies or the available chemotherapy doublets, leaving them with reduced treatment options. In the US it is estimated that the treatment indication of never smokers with NSCLC has an annual market potential of $1.5 billion, and a global estimated annual market potential of over $2.6 billion.

Ø LP-184 – Seven cohorts of patients have been enrolled and dosed – in escalating doses – in the ongoing Phase 1A clinical trial – a first-in-human Phase 1 basket trial across multiple solid tumor indications that are advanced and refractory to existing standard-of-care therapies. We expect to reach a dosage level in the coming cohort where therapeutic concentrations of the drug should be attainable based on our pharmacokinetic and pharmacodynamic analyses. The trial is actively enrolling patients across multiple US centers that have relapsed/refractory advanced solid tumors, such as pancreatic cancer, glioblastoma (GBM), lung, triple-negative breast cancer, and multiple other solid tumor types with DNA damage response deficiencies. No dose-limiting toxicities have been observed to date in the LP-184 trial, and the Company believes that enrollment should be complete this year and on-track for an initial readout of safety and molecular correlation data by the close of the year. The dosage and safety data obtained in the Phase 1A trial are expected to be used to advance the central nervous system (CNS) indications for a future Phase 1b/2 trial to be sponsored by Lantern’s wholly owned subsidiary, Starlight Therapeutics, as well as other later phase trials in select tumors that have shown superior responsiveness to LP-184 and meet with genomically guided criteria related to drug-response. Lantern has also made advancements toward a key milestone related to the development of a quantitative PCR-based molecular diagnostic test that may help in identifying patients with the best likelihood of response and benefit from treatment with LP-184.

AI and preclinical studies are also ongoing to further refine drug combination studies supporting the use of LP-184 to improve the durability or overall response rates in combination with FDA approved drugs that are widely used in cancer treatment – especially PARP inhibitors, and immune checkpoint inhibitors. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $12+ billion, consisting of $4.5+ billion for CNS cancers and $7.5+ billion for solid tumors.

Ø LP-284 – The third cohort of patients are being dosed, and no dose-limiting toxicities have been observed in the LP-284 Phase 1A clinical trial. We expect to open additional sites in the US throughout the third quarter with the potential to advance to Phase 1B and 2 by the close of 2024 or early 2025. LP-284 has shown nanomolar potency across multiple published in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other advanced NHL cancer subtypes with DNA damage response deficiencies, notably those with compromised functioning of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions. Nearly all MCL, DHL, and HGBL patients relapse from the current 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, DHL, and HGBLs are diagnosed in 16,000-20,000 patients each year and have an estimated annual market potential of over $3+ billion.

We have also begun a review of some notable mechanisms-of-action of LP-284 that may be leveraged in other diseases and conditions. Lantern expects to review those preclinical studies and findings later this quarter.

RADR Platform Growth and Development:

Ø RADR continues to advance in size, scope, and capabilities and is also progressing towards becoming recognized as a standard for AI-driven drug development in oncology – for both early-stage development and later-stage patient biomarker and combination therapy identification. Lantern will potentially focus additional data growth efforts of the RADR platform on: drug sensitivity data, combination treatment outcome data, and biomarker data in rare cancers, and on emerging synthetic lethal targets that are aimed at accelerating the development of new therapies for Lantern and its partners. The scope of RADR’s data has broadened with a strategic focus on additional classes of compounds, detailed data on chemical and biochemical features and drug-interaction data. Real-world data from clinical studies such as those being obtained from liquid biopsy, and data from preclinical combination studies that aim to define drug interaction and optimal dosage are being incorporated into the datapoints and data sets powering RADR.

Lantern also leveraged the RADR platform in developing a drug-development collaboration with Oregon Therapeutics with a focus on accelerating the development and decision path towards a first-in-human launch of the drug-candidate, XCE853 into the clinic. The AI-enabled collaboration with Oregon Therapeutics aims to refine and expand the positioning of XCE853, a novel protein disulfide isomerase (PDI) inhibitor, in new and targeted oncology indications, including for drug-resistant tumors. Lantern Pharma is receiving equal IP co-ownership and drug development rights in newly discovered biomarkers, novel indications, and use for new pharmacological strategies for XCE853.

Additionally, the RADR platform’s generative AI capabilities, focusing on molecular optimization and automated feature extraction to improve understanding and prediction of molecular dynamics, safety, and drug-drug interactions are planned to increase in functionality and scope in the coming quarters for both small molecule development and increasingly for ADC development, analytics and characterization.

Second Quarter 2024 Financial Highlights

Ø Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $33.3 million as of June 30, 2024, compared to approximately $41.3 million as of December 31, 2023. The quarterly cash burn rate continues to reflect our capital-efficient, collaborator-centered business model.

Ø R&D Expenses: Research and development expenses were approximately $3.9 million for the quarter ended June 30, 2024, compared to approximately $3.6 million for the quarter ended June 30, 2023.

Ø G&A Expenses: General and administrative expenses were approximately $1.5 million for the quarter ended June 30, 2024, compared to approximately $1.6 million for the quarter ended June 30, 2023.

Ø Net Loss: Net loss was approximately $4.96 million (or $0.46 per share) for the quarter ended June 30, 2024, compared to a net loss of approximately $4.75 million (or $0.44 per share) for the quarter ended June 30, 2023.

Ø Total Share and Warrant Count: There were no warrant exercises during the three months ended June 30, 2024. Following June 30, 2024, additional warrants were exercised which increased the Company’s total shares outstanding and reduced the number of outstanding warrants. As of the date of this press release, the Company has 10,764,725 shares of common stock outstanding, and outstanding warrants to purchase 70,000 shares of common stock.

Additional Operational Highlights:

Ø A publication was made in the AACR (Free AACR Whitepaper) Journals, Cancer Research Communications showcasing the potential for LP-184 to synergize with PARP inhibitors in a wide range of solid tumors that are HRD (homologous repair deficient). The preclinical findings in the paper illustrate the potential of LP-184 to be a pan-HRD cancer therapeutic – which could be the first drug of this type in this class. We believe the data and results support clinical evaluation of LP-184 in a large subset of HRD solid tumors.

Ø New data and scientific findings conducted in conjunction with Drs. Yong Du and Shiaw-Yih (Phoebus) Lin at MD Anderson were presented at The Immuno-Oncology Summit 2024. The findings showcased what Lantern believes to be the role of LP-184 to be combined with checkpoint inhibitors to provide greater response in TNBC due to synergy and to potentially transform TNBC tumors that are unresponsive (cold) to checkpoint inhibitors to responsive (hot). The poster was titled: LP-184, a Novel Acylfulvene, Sensitizes Immuno-Refractory Triple Negative Breast Cancers (TNBCs) To Anti-PD1 Therapy by Affecting the Tumor Microenvironment.

Ø With a focus on increasing visibility and awareness of the Lantern portfolio and capabilities, the Company launched Webinar Wednesdays in April. They are currently planned to be held on the last Wednesday of each month and are designed to showcase industry leaders in AI and drug development, as well as clinicians working in collaboration with Lantern’s portfolio of drug-candidates. The next three Webinar Wednesdays will include the topics of: 1) LP-300’s clinical results to-date, 2) RADR and our industry-leading ability to predict if a molecule or drug-compound will cross the BBB (Blood-Brain-Barrier), and 3) The role of LP-184 in synergizing with checkpoint inhibitors and IO agents.

Earnings Call and Webinar Details:

Lantern will host its 2nd quarter 2024 earnings call and webinar today, August 8th, 2024, at 4:30 p.m. ET. A link to register can be accessed at: Lantern 2nd Quarter 2024 Earnings Call & Webinar Link

Ø Related presentation materials will be accessible at: View Source
Ø A replay of the 2nd quarter 2024 earnings call and webinar will be available at: View Source

On August 8, 2024 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the second quarter of 2024 and provided an overview of its clinical programs and anticipated milestones (Press release, Vincerx Pharma, AUG 8, 2024, View Source [SID1234645628]).

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"During the second quarter, our team focused on execution and the continued enrollment of patients in our ongoing Phase 1 studies for our potentially best-in-class ADC, VIP943, and first-in-class SMDC, VIP236," said Ahmed Hamdy, M.D., Chief Executive Officer. "We look forward to evaluating the results from additional cohorts and sharing data by end of Q3 for VIP236 and by end of year for VIP943."

SECOND QUARTER 2024 CLINICAL PROGRAM HIGHLIGHTS AND ANTICIPATED MILESTONES

VIP943

VIP943, a novel CD123-targeted ADC created from Vincerx’s VersAptx platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with Vincerx’s CellTrapper technology. Its next-generation effector chemistry was designed to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities.
Vincerx expects to share additional Phase 1 study data for VIP943 for patients with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) (NCT06034275) by the end of Q4 2024.
VIP236

VIP236 is an αVβ3 SMDC conjugated to an optimized camptothecin (CPT) payload created from Vincerx’s VersAptx platform. VIP236 is a first-in-class drug designed to deliver its optimized CPT payload directly to tumor tissues to overcome chemotherapy-related side effects. Preclinical studies have shown 11 times more optimized CPT is delivered to the cancerous tissues than found circulating in the blood. In addition, the optimized CPT is designed to limit drug transporter liabilities, a common mechanism for cancer resistance to chemotherapy.
Vincerx looks forward to sharing additional data from this Phase 1 study (NTC05371054) by the end of Q3 2024.
Enitociclib

Enitociclib is a highly selective CDK9 inhibitor designed to block the activation of RNA polymerase II, leading to the reduction of oncogenes, including MYC and MCL1.
Enitociclib is currently in a Phase 1 dose-escalation study (NTC05371054) evaluating the combination of enitociclib, venetoclax and prednisone in diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). This study is being conducted in collaboration with the National Institutes of Health (NIH).
At the AACR (Free AACR Whitepaper) Advances in Malignant Lymphoma meeting in June 2024, the NIH presented the interim study results previously shared by Vincerx in January 2024 and May 2024.
VIP924

VIP924 is a first-in-class CXCR5-targeted ADC created from Vincerx’s VersAptx platform.
VIP924 can be evaluated in B-cell malignancies, including mantle cell lymphoma, follicular lymphoma, DLBCL, and chronic lymphocytic leukemia , as a monotherapy and in combination.
IND application is anticipated in early 2026, pending funding.
VersAptx Platform

VersAptx is Vincerx’s versatile and adaptable, next-generation bioconjugation platform. The modular nature of this platform enables the combination of different targeting, linker, and payload technologies to develop bespoke bioconjugates to address different cancer biologies.
SECOND QUARTER 2024 FINANCIAL RESULTS

Vincerx had approximately $16.3 million in cash, cash equivalents and marketable securities as of June 30, 2024, as compared to approximately $5.1 million as of March 31, 2024. Based on its current business plans and assumptions, Vincerx believes its available capital, including the proceeds of its April financing of approximately $16.9 million, will be sufficient to meet its operating requirements through the end of 2024.
Research and development expenses for the second quarter ended June 30, 2024 were approximately $3.8 million, as compared to approximately $8.2 million for the same period in 2023. This decrease is primarily the result of decreases in research services of approximately $1.8 million, manufacturing services associated with our ADC program of approximately $1.6 million, and personnel related expenses of approximately $0.8 million.
General and administrative expenses for the second quarter ended June 30, 2024 were approximately $3.6 million, as compared to approximately $3.8 million for the same period in 2023. This decrease is primarily driven by decreases in personnel-related expenses of approximately $0.3 million.
For the second quarter ended June 30, 2024, Vincerx reported a net loss of approximately $1.8 million, or $0.05 per share. For the second quarter ended June 30, 2023, Vincerx reported a net loss of approximately $11.6 million, or $0.54 per share.

On August 8, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an update on the Company’s clinical progress and plans for expansion (Press release, Bio-Path Holdings, AUG 8, 2024, View Source [SID1234645558]).

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"The Bio-Path team continues to work diligently toward advancing our important clinical work and have made meaningful progress in a number of areas critical to each program’s success," said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. "With the increased clinical data that we have generated, we are now able to develop the biomarkers needed to incorporate into our oncology studies. In addition, we have completed preparations for preclinical work to support advancing prexigebersen as a potential treatment for obesity. In tandem, we are designing development plans for first-in-human clinical studies in this expansive global market for weight loss."

"The incremental advances that we are making across these programs collectively push our DNAbilize platform closer to delivering these medicines to patients. Moreover, we are continuing to see the broader potential of our platform beyond oncology and look forward to realizing its potential across multiple indications, starting with obesity," continued Mr. Nielsen. Clinical Program Overview Bio-Path’s clinical development program consists of one Phase 2 clinical trial and three Phase 1 or 1/1b clinical trials.

Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment and is currently expanding prexigebersen preclinical studies for the treatment of obesity. Development of Molecular Biomarkers – Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment, the goal of which is to identify patients with a genetic profile more likely to respond to treatment, thereby improving the probability of success for this program. The emerging role of biomarkers has enhanced cancer development over the past decade and has become a more common companion to many oncology programs.

Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients. This trial is comprised of three separate cohorts of patients and treatments, each separately approvable by the FDA as a new drug indication. The first two cohorts are treating patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes untreated AML patients, and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort is treating relapsed/refractory AML patients, who are venetoclax-resistant or intolerant, with the two-drug combination of prexigebersen and decitabine. Based on recent interim data for safety and efficacy, the Company plans to pursue next development steps by applying molecular biomarkers to future patient selection for enrollment into the Phase 2 clinical trial. Outcomes for these older patients who are unable to receive intensive chemotherapy due to the challenging side effect profile remain suboptimal with a median survival of only five to ten months. The study is currently paused for an interim analysis, amendment preparation and U.S. Food and Drug Administration (FDA) review. Bio-Path expects to complete enrollment in cohorts 1 and 2 of the study over the next eighteen months. Phase 1/1b Clinical Trial in BP1001-A in

Advanced Solid Tumors – A Phase 1/1b clinical trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer, is ongoing. BP1001-A is a modified product candidate that incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. The Phase 1 study has advanced to the second, higher dose level. The Phase 1b portion of the study is expected to commence after successful completion of the three

BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late stage pancreatic cancer. In recent months, Bio-Path advanced to dose level 2 and expects to complete enrollment in order to advance to dose level 3 by year-end.

Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. The drug venetoclax treats AML patients by blocking the activity of the Bcl-2 protein in AML patients. However, patients become resistant to venetoclax. BP1002 treats the Bcl2 target by blocking the cell’s ability to produce Bcl-2, and could have the potential to eliminate the need for venetoclax.

AML patients that fail frontline venetoclax-based therapy have very poor prognosis with median overall survival of less than three months. The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities. Bio-Path recently completed the second dose cohort of 40 mg/m2 and is completing an analysis of PK/PD data to be submitted to the FDA in order to advance to the next dose level. Upon submission of data and approval from FDA, Bio-Path expects to advance to dose level 3 in the fourth quarter of 2024.

Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL) – A Phase 1 clinical trial to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients is currently ongoing. The Phase 1 clinical trial is being conducted at the Georgia Cancer Center, The University of Texas Southwestern and New York Medical College. In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial. A total of six evaluable patients are scheduled to be treated over two dose levels with BP1002 monotherapy in a standard 3+3 design, unless there is a dose limiting toxicity which would require an additional three patients to be tested. There were no dose limiting toxicities in the first dose cohort (20 mg/m2). Enrollment has continued for patients in the second BP1002 dose cohort of 40 mg/m2 and the Company expects to complete enrollment and to review these data by year-end.

Preclinical Work for BP1003 – The Company continues to advance its drug candidate, BP1003, for the treatment of advanced solid tumors, including pancreatic cancer. BP1003 is an antisense RNAi nanoparticle targeting the STAT3 protein. Plans are to conduct a Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors (pancreatic, non-small cell lung cancer). Prexigebersen as Potential Treatment for Obesity and Obesity-related Cancers – The RNAi target of prexigebersen is the Grb2 protein, which is involved in activating the RAS/ERK pathway for cell growth. By blocking the cell’s ability to produce Grb2, prexigebersen treatment may limit cell growth. In obesity, two such pathways are related to leptin and insulin. Activation of leptin or insulin receptors can stimulate the RAS/ERK pathway via Grb2i.

Bio-Path believes development of prexigebersen for the treatment for obesity and obesity-related cancers could be accelerated given the large amount of safety data from prexigebersen treatment of leukemia patients and the continued unmet medical need. The Company is preparing for preclinical development evaluating prexigebersen for the treatment of obesity and will continue thereafter to conduct additional Investigational New Drug (IND)-enabling studies with an aim to advance prexigebersen into first-in-human studies in this indication.

On August 8, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported the presentation of one-year clinical efficacy Phase 2 data for its lead compound EVX-01 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, taking place in Barcelona, Spain, from September 13-17, 2024 (Press release, Evaxion Biotech, AUG 8, 2024, View Source [SID1234645596]). The EVX-01 vaccine is a personalized therapy currently being assessed in patient with advanced melanoma (skin cancer).

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Christian Kanstrup, CEO of Evaxion, comments: "Having our abstract selected for presentation by the ESMO (Free ESMO Whitepaper) Congress 2024 Scientific Committee is a testament to the significant progress and impact of our work in the field of medical oncology. This is one of the most prestigious medical oncology conferences in the world and, as such, a great opportunity for us to make the data available to a large global audience of experts, researchers and collaborators, as well as potential partners. Presenting one-year Phase 2 clinical efficacy data for our lead pipeline candidate is a major milestone for Evaxion and advancing our own high-value programs to key value inflection points is an important part of our strategy."

Evaxion’s innovative approach to develop personalized cancer vaccines builds on its AI-Immunology platform. The vaccines are designed to target the unique genetic makeup of an individual’s tumor and are tailored to the patients’ immune system, potentially enhancing the efficacy of treatment and improving patient outcomes.

Presentation Details:

Abstract Title: Phase 2 study of AI-designed personalized neoantigen cancer vaccine, EVX-01, in combination with pembrolizumab in advanced melanoma
Abstract#: 1084P
Poster#: 2904
Track: Melonama and other skin tumours
Location: Hall 6
Date/Time: September 14 at 12.00 – 13.00 CEST
Presenter: Dr. Paola Queirolo, Director, Medical Oncology of Melanoma, Sarcoma and Rare Tumors, European Institue of Oncology, Milan, Italy
About EVX-01 Phase 2 Clinical Trial

EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC that, together with leading principal investigators and research centers from Italy and Australia, aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 therapy KEYTRUDA (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.