On July 30, 2020 Lantern Pharma (NASDAQ: LTRN), a clinical stage biotechnology company using its proprietary RADR artificial intelligence ("A.I.") platform to improve drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, reported its financial results for the second quarter ended June 30, 2020, and provided an update on its R&D pipeline and other corporate developments (Press release, Lantern Pharma, JUL 30, 2020, View Source [SID1234562601]).

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"Lantern Pharma achieved important scientific and operational milestones during the quarter that have us well positioned for growth as we focus on being the leader in A.I.-enabled oncology drug development," said Panna Sharma, CEO and President of Lantern Pharma. "Our proprietary RADR platform recently surpassed 500 million data points, further accelerating our path to one billion curated oncology data points in the next few quarters. We have also advanced our manufacturing capabilities and network for our upcoming clinical trials for LP-300 in non-small cell lung cancer among never smokers, and for LP-184 in genomically defined solid tumors and glioblastoma. On June 15, we completed a successful IPO, raising gross proceeds of $26.3 million, significantly strengthening the Company’s balance sheet and provides additional resources to support the continued development of our promising and growing pipeline of targeted cancer therapies. Our approach and vision is to bring cancer therapies to market faster and with reduced cost and risk and ultimately improve patient outcomes. We are entering what I believe is the Golden Age of A.I. where industries will continue to be rapidly transformed and massive advancements made that can benefit medicine, health and those willing to invest in and develop these disruptive opportunities."

Corporate and Scientific Highlights

Closed initial public offering – In June 2020, Lantern Pharma closed its initial public offering of 1,750,000 shares of its common stock at a public offering price of $15.00 per share, for gross proceeds of $26,250,000, before deducting underwriting discounts, commissions and offering expenses.
Initiated multiple preclinical studies for LP-184 in genomically defined solid tumors and Glioblastoma (GBM) – The studies aim to further validate the genomic signature of LP-184 and help to inform IND development efforts. The data generated in these studies will also support the continued expansion of our RADR (Response Algorithm for Drug Positioning and Rescue) A.I. platform.
RADR surpasses 500 million data points – Lantern Pharma is ahead of its initial platform development schedule of reaching 400 million data points by the end of 2020. The Company is now on track to reach over 1 billion data points within the next several quarters.
Presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) – Two presentations that detailed Lantern Pharma’s use of its RADR A.I. platform in the development of LP-184, a molecule with nanomolar potency and strong activity in cancers with KEAP1 and KRAS mutations. LP-184 is one of three cancer drug candidates in Lantern Pharma’s pipeline.
Advanced manufacturing capabilities and network to support LP-300 and LP-184 trials – the Company established a manufacturing network in preparation for its Phase 2 clinical trial of LP-300 in non-small cell lung cancer among never smokers and for LP-184 in preclinical development for genomically defined solid tumors that overexpress certain RNA as well as for glioblastoma multiforme.
Continue to advance our collaborations with leading academic and cancer research centers – for the purposes of examining additional potential cancer indications for our drugs, improving and validating the existing genomic signatures that correspond to patient response, establishing sites, and recruiting potential investigators for upcoming clinical trials.
Q2 2020 Financial Highlights

Cash Position: Cash and cash equivalents were $23.8 million as of June 30, 2020, compared to $1.2 million as of December 31, 2019. The increase was primarily due to proceeds from the IPO in June 2020.

R&D Expenses: Research and development expenses were $157,023 for the quarter ended June 30, 2020, compared to $361,273 for the quarter ended June 30, 2019. The decrease was primarily attributable to reductions in product candidate manufacturing related expenses reflecting completion of process development and scale-up studies conducted in the prior year period.

G&A Expenses: General and administrative expenses were $676,399 for the quarter ended June 30, 2020, compared to $268,120 for the quarter ended June 30, 2019. This increase was primarily due to an increase in expenses associated with transitioning to and becoming a public company.

Net Loss: Net loss was $833,422 for the quarter ended June 30, 2020, compared to a net loss of $629,393 for the quarter ended June 30, 2019.

Sharma continued, "Developing drugs by leveraging artificial intelligence is central to transforming the cost and efficiency of the pharma industry and improving the personalization of therapies for cancer patients. By identifying clinical candidates, together with relevant genomic, clinical and phenotypic data, we believe our approach will help us design more efficient pre-clinical studies and more targeted clinical trials, thereby accelerating our drug candidates’ time to approval and eventually to market. RADR is central to our process in achieving this outcome rapidly and with reduced costs. We currently have three compounds in development, one in a Phase 2 trial in prostate cancer with our partner, Oncology Venture, one that is preparing to enter into a Phase 2 trial, and one in preclinical development."

"We believe we have developed a sustainable and scalable biopharma business model by combining a unique, oncology-focused big-data platform that leverages artificial intelligence and machine learning with active clinical and preclinical programs that are being advanced in targeted cancer therapeutic areas with significant clinical needs," concluded Sharma.

Conference Call:

Lantern Pharma will host a conference call and webcast today at 8:00 a.m. ET.

Conference Call & Webcast Details

Toll-free Domestic & Canada: 800.791.4813 – conference ID 10552
International: 785-424-1102 – conference ID 10552
US and Canada callers one touch dial: +1.800.791.4813,,10552#
The webcast will be available in the "Investors" section of the company website at View Source under the News & Events page.

Replay Details

A replay of the conference call will be available for replay until 11:59 pm ET August 30, 2020.
Replay Number: 1-888-567-0053, no passcode will be needed.

A live audio-only webcast and related presentation materials will also be accessible on the Lantern Pharma corporate website: View Source. Web participants are encouraged to register 15 minutes prior to the start of the call. The webcast will be archived on the Lantern Pharma website for 6 months.

On July 30, 2020 Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), reported that with the initiation of our first-in-human Phase 1 clinical trial for GLR2007, our internally-invented, cyclin-dependent kinase 4/6 (CDK4/6) inhibitor as a potential therapy for advanced solid tumors (Press release, Gan and Lee Pharmaceuticals, JUL 30, 2020, View Source;lee-pharmaceuticals-initiates-first-in-human-phase-1-clinical-trial-for-new-anti-tumor-drug-glr2007-301103340.html [SID1234562599]). CDK4/6 activity is central to cell cycle regulation and has a key role in the occurrence and progression of a variety of cancers.1 2 Therefore, Gan & Lee views CDK4/6 as an attractive therapeutic target agent. This Phase 1 clinical trial is a multicenter, open- label, study designed to establish the safety, tolerability, and optimal dosing strategy of GLR2007 in patients with advanced solid tumors. Dr. Lawrence Hill, CEO, Gan & Lee US says, "Based on encouraging pre-clinical data and the high unmet need, 3 GLR2007 is a promising new investigational compound that could potentially address unmet medical need for patients with advanced solid tumors. We are excited to begin this Phase 1 clinical study (NCT04444427) and look forward to collaborating with patients, caregivers and the medical community to make a meaningful difference to people living with cancer."

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On July 30, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported that the company will release its second quarter 2020 financial results after the market closes on Thursday, August 13, 2020 (Press release, CohBar, JUL 30, 2020, View Source [SID1234562598]). Management will host a conference call with a slide presentation at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details for the Conference Call and Slide Presentation:

Date: August 13, 2020
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

Dial-in U.S. and Canada: (877) 451-6152
Dial-in International: (201) 389-0879
Conference ID No.: 13707178
Slide Presentation

Go to www.webex.com, click on the ‘Join a Meeting’ button and enter meeting number 145 324 6260 and Password CWBR, or
Go to www.cohbar.com and click on Q2 2020 Shareholder Presentation at top of homepage.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Webex approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on August 13, 2020, through 11:59 p.m. Eastern Time on September 3, 2020. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13707178. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

On June 30, 2020 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and six months ended June 30, 2020 (Press release, Odonate Therapeutics, JUL 30, 2020, View Source [SID1234562597]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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As of June 30, 2020, Odonate had $125.4 million in cash, compared to $180.5 million as of December 31, 2019. Net cash used in operating activities for the six months ended June 30, 2020 was $56.5 million, compared to $50.3 million for the same period in 2019. Odonate’s net loss for the three and six months ended June 30, 2020 was $33.4 million and $63.6 million, or $1.09 and $2.07 per share, respectively, compared to $28.7 million and $57.3 million, or $1.15 and $2.31 per share, respectively, for the same periods in 2019.

"We continue to expect to report top-line results from CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer, in the third quarter of 2020," said Kevin Tang, Chief Executive Officer of Odonate.

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.

On July 30, 2020 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported that the Company will report second quarter 2020 financial results and provide a business update on Thursday, August 6, 2020 (Press release, Savara, JUL 30, 2020, View Source [SID1234562596]). Savara management will host a conference call/webcast at 4:30 p.m. Eastern Time (ET)/1:30 p.m. Pacific Time (PT).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Shareholders and other interested parties may access the call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and requesting the "Savara Inc." call. A live webcast of the call can be accessed on the Investors page of Savara’s website at View Source

Approximately one hour after the call, a telephone replay will be available and will remain available through August 13, 2020 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10146176. A webcast replay will be available on the Investors page of Savara’s website and will remain available for 30 days.