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 [SID1234562571]).

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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 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that it will report second quarter 2020 financial results on Thursday, August 6, 2020, after the U.S. financial markets close (Press release, Dynavax Technologies, JUL 30, 2020, View Source [SID1234562570]).

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Dynavax will host a conference call and live audio webcast on Thursday, August 6, 2020 at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at www.dynavax.com. Alternatively, participants may dial (866) 420-4066 (domestic) or (409) 217-8237 (international) and refer to conference ID 8187870. A replay of the webcast will be available for 30 days following the live event.

On July 30, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the second quarter ended June 30, 2020 and provided an update on recent business progress (Press release, Veracyte, JUL 30, 2020, View Source [SID1234562569]).

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"We delivered solid second quarter results in the face of headwinds from the COVID-19 pandemic," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Our genomic testing volume doubled between April and June as hospitals started performing more non-emergency procedures and physician practices began to open. We have begun leveraging opportunities for new virtual sales and marketing models to increase efficiency and drive growth. We also remain on track to bring four new tests to market in 2021, further accelerating our growth. Additionally, we continued to grow our biopharmaceutical and diagnostic partnerships to fuel our global expansion with a comprehensive test menu that extends our total addressable market beyond the $40 billion for our current and pipeline products."

Second Quarter 2020 Financial Results

For the second quarter of 2020:

Total revenue was $20.7 million, comprising $16.9 million in testing and product revenue and $3.8 million in biopharmaceutical partnership and collaboration revenue;
Gross Margin was 63%;
Operating Expenses, Excluding Cost of Revenue were $24.1 million;
Net Loss and Comprehensive Loss was $11.0 million;
Basic and Diluted Net Loss Per Common Share was $0.22;
Net Cash Used in Operating Activities was $8.4 million; and
Cash and Cash Equivalents were $147.5 million at June 30, 2020.
For the six-month period ended June 30, 2020:

Total revenue was $51.8 million, comprising $47.3 million in testing and product revenue and $4.5 million in biopharmaceutical partnership and collaboration revenue;
Gross Margin was 62%;
Operating Expenses, Excluding Cost of Revenue were $55.2 million;
Net Loss and Comprehensive Loss was $22.7 million;
Basic and Diluted Net Loss Per Common Share was $0.45; and
Net Cash Used in Operating Activities was $13.7 million.
Second Quarter 2020 and Recent Business Highlights

Core Diagnostics Business:

Increased our reported genomic testing volume (Afirma, Percepta and Envisia), with June total volume doubling that of April.
Expanded virtual customer engagement program, conducting more than two dozen virtual educational events, email campaigns and other digital outreach to clinicians.
Strengthened our library of published clinical evidence supporting use of the Afirma Xpression Atlas (Cancer Cytopathology) and the Envisia Genomic Classifier (CHEST and AJRCCM). The AJRCCM study further demonstrates the Envisia classifier’s ability to improve diagnosis of idiopathic pulmonary fibrosis without the need for surgery.
LymphMark – Submitted De Novo classification request to the FDA for the lymphoma subtyping test, which is designed to help inform diagnosis and better treatment decisions.
On track to launch four new products in 2021: Nasal swab test for early lung cancer detection; Percepta Atlas to inform treatment decisions in lung cancer; Envisia international launch on the nCounter; and LymphMark, if the FDA grants our De Novo classification request.
Signed distributor contracts that will make Veracyte’s advanced genomic testing on the nCounter system available to laboratories throughout the Asia Pacific region, as well as in Australia and New Zealand.
Strategic Collaborations:

CareDx – Formed strategic collaboration through which CareDx has the exclusive right to develop solid organ transplant rejection tests on the nCounter Analysis System, fueling our global menu expansion.
Generated revenue from four biopharmaceutical and diagnostics partners: Eli Lilly/Loxo Oncology, Johnson & Johnson Innovation, Acerta Pharma and CareDx.
MAVIDx – Signed strategic agreement, taking an equity stake in MAVIDx, for the new company to develop COVID-19 and other infectious disease tests for ultra-high throughput testing on the nCounter system. A Harvard University report estimates the market will require 20 million tests per day in the United States alone.
Conference Call and Webcast Details

On July 30, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $268.9 million for the second quarter ended June 30, 2020, compared to $199.9 million for the same period of 2019 (Press release, Exact Sciences, JUL 30, 2020, View Source [SID1234562568]).

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Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

"Cologuard helps solve the problem of COVID-related missed cancer screenings because it’s a convenient, accurate, at-home test, and we believe this will accelerate adoption," said Kevin Conroy, Chairman and CEO. "COVID-19 is elevating the importance of our Precision Oncology tests, as patients and physicians look for smarter, faster answers to guide their cancer treatment decisions. As diagnostic testing continues to play a larger, more important role in cancer care, Exact Sciences is in a unique position to create value at every step along the way."

Second Quarter 2020 Financial Results

For the three-month period ended June 30, 2020, as compared to the same period of 2019 (where applicable):

Total revenue was $268.9 million, compared to $199.9 million
Screening revenue was $131.3 million, a decrease of 34 percent
Precision Oncology revenue was $103.0 million
COVID-19 testing revenue was $34.6 million
Gross margin including amortization of acquired intangible assets was 63 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 71 percent
Other operating income consisted of a one-time payment of $23.7 million from the Coronavirus Aid, Relief, and Economic Security (CARES) Act Provider Relief Fund
Net loss was $86.1 million, or $0.58 per share, compared to a net loss of $38.5 million, or $0.30 per share
EBITDA was $(26.0) million and adjusted EBITDA was $(4.9) million
Non-cash interest expense related to convertible debt was $20.1 million, compared to $10.7 million
Cash, cash equivalents, and marketable securities were $1.2 billion at the end of the quarter
Screening includes laboratory service revenue from Cologuard and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype DX products and the recent Paradigm acquisition.

Non-GAAP Disclosure
In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and non-GAAP gross profit. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations."

Second Quarter Conference Call & Webcast
Company management will host a conference call and webcast on Thursday, July 30, 2020, at 5 p.m. ET to discuss second quarter 2020 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-235-7650 and international callers should dial +1-647-689-4171. The access code for both domestic and international callers is 8183605.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 8183605. The webcast, conference call and replay are open to all interested parties.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx only.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On July 30, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its second quarter 2020 financial results and provided an update on the company, including its second quarter progress with eganelisib (also known as IPI-549), the company’s first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition (Press release, Infinity Pharmaceuticals, JUL 30, 2020, View Source [SID1234562567]).

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"We have made important clinical progress this quarter including the generation of early, but encouraging signals of clinical activity in the triple negative breast cancer cohort of MARIO-3," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "While these data are preliminary, we are excited by the potential to bring eganelisib to the front-line setting for the deadliest form of breast cancer and plan to present these data later this year."

Ms. Perkins continued, "We are also pleased that the dose reduction implemented for MARIO-275 from 40mg QD to 30mg QD has enabled the continued treatment of patients previously enrolled in the study. We will conduct an interim efficacy analysis on these patients by the end of the year which will inform next steps."

Key Q2 2020 Updates:

Clinical and Regulatory:

MARIO-275: MARIO-275 is the company’s ongoing controlled, randomized Phase 2 study evaluating eganelisib in combination with Opdivo in platinum-refractory, I/O naïve patients with advanced urothelial cancer (aUC), in collaboration with Bristol Myers Squibb, or BMS.
Infinity implemented a dose reduction from 40mg QD to 30mg QD which has reduced the reversible liver enzyme elevations which were reported at the first scheduled MARIO-275 Independent Data Monitoring Committee (IDMC) meeting. Infinity will continue treatment of the currently enrolled patients and conduct an interim efficacy analysis by the end of the year which will inform next steps.
MARIO-3: MARIO-3 is the company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in novel triple combination in the front-line setting with Tecentriq and Abraxane in triple negative breast cancer (TNBC) and with Tecentriq and Avastin in renal cell cancer (RCC).
Early, encouraging clinical activity has been observed in the TNBC cohort of MARIO-3. Infinity plans to present these initial clinical data later this year.
The majority of identified sites are up and running. Infinity has observed an increase in site initiation and patient screening, and Infinity is working closely with the CRO on enrollment initiatives.
Enrollment completion is expected in the RCC cohort by the end of 2020 and the TNBC cohort by the end of Q1 2021.
MARIO-1: Infinity plans to share clinical and translational data from MARIO-1 later this year.
Arcus Collaboration: A Phase 1b collaboration study with Arcus Biosciences, which is being conducted by Arcus, is evaluating a checkpoint-inhibitor free, novel triple-combination regimen of eganelisib + AB928 (dual adenosine receptor antagonist) + Doxil in up to approximately 40 advanced TNBC patients.
COVID-19 Impact: As the situation with COVID-19 continues to evolve, the company is diligently evaluating impacts on enrollment, site initiations, patient treatment and protocol compliance. Infinity continues to work closely with trial sites to support the continued treatment of patients in compliance with study protocols and is proactively working to mitigate disruptions to enrollment and trial timelines.
Corporate:

Dr. Brian Schwartz joined Infinity in a consulting Chief Physician role in April. He is actively providing guidance and insight across Infinity’s clinical programs, leveraging his deep experience in clinical development, particularly in oncology. Dr. Schwartz brings an impressive track record of experience and success, most recently serving as Chief Medical Officer at ArQule up until its acquisition by Merck. Dr. Schwartz is providing guidance and insight across Infinity’s clinical programs, leveraging his deep experience in clinical development, particularly in oncology.
Second Quarter 2020 Financial Results:

At June 30, 2020, Infinity had total cash, cash equivalents and available-for-sale securities of $42.7 million, compared to $50.3 million at March 31, 2020.
Research and development expense for the second quarter of 2020 was $6.1 million, compared to $6.1 million for the same period in 2019.
General and administrative expense was $2.9 million for the second quarter of 2020, compared to $3.8 million for the same period in 2019. The decrease is primarily related to a decrease in consulting and stock compensation.
Net loss for the second quarter of 2020 was $9.5 million, or a basic and diluted loss per common share of $0.16, compared to a net loss of $10.5 million, or a basic and diluted loss per common share of $0.18 for the same period in 2019.
2020 Financial Outlook:

Net Loss: Infinity expects net loss for 2020 to range from $35 million to $45 million.

Cash and Investments: Infinity expects to end 2020 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $20 million to $30 million.

Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities, will be adequate to satisfy the company’s capital needs into 2H2021. Infinity’s financial guidance does not include potential additional funding or business development activities, a potential $5 million milestone payment from BVF based on PellePharm’s ongoing Phase 3 clinical trial of patidegib topical gel in Gorlin Syndrome, or any milestones from, or the sale of the company’s equity interest in, PellePharm.

Conference Call Information

Infinity will host a conference call today, July 30, 2020, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 7893533. An archived version of the webcast will be available on Infinity’s website for 30 days.