Merck Hosts Organon Investor Day Outlining New Company’s Vision, Focus and Business Model for Sustained Growth

On May 3, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will host Organon management at a meeting with the investment community (Press release, Merck & Co, MAY 3, 2021, View Source [SID1234579010]). Management will detail plans for how Organon is expected to drive sustainable growth and shareholder value as a standalone company.

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"The spinoff of Organon will help Merck become a leaner, more focused and agile company with stronger growth, and will enable significant operating efficiencies. Organon, as a standalone company, will be better positioned to realize its potential and to have a meaningful impact, particularly in women’s health", said Rob Davis, president, Merck. "We believe this transaction will create value for the patients both companies serve and for Merck shareholders."

At launch, Organon’s portfolio will consist of more than 60 medicines and products across its three core franchises: Women’s Health, Biosimilars and Established Brands.

"On June 3rd, Organon will launch as a new company, with solid growth opportunities and the ability to make an impact in women’s health," said Kevin Ali, Organon’s chief executive officer. "Our day one portfolio consists of many well-known products that were once core to Merck’s business but have since strategically received limited resources and investment. These are important medicines that we believe will be responsive to commercial investment, and with renewed management focus, we expect the portfolio to generate low to mid-single organic revenue growth off of a 2021 base. Additionally, as the only company of our size to be focused on women’s health, we have a significant opportunity to do more to support women and their health, and the time is right to bring forward more options for patients and healthcare providers."

During the event, members of Organon’s leadership team will outline the company’s strategic priorities to generate value for patients and shareholders. These include:

Developing a new commercial strategy and roadmap for sustainable growth. Organon has a strong and balanced foundation with a diverse portfolio of impactful brands built on a broad geographic footprint. With management focus and renewed investment, the company intends to capitalize on the growth potential of the existing Women’s Health and Biosimilars portfolios, while optimizing the well-known brands and associated cash flows of the Established Brands business. Organon will launch with a large commercial footprint with a direct sales presence in 58 markets, while supplying products to over 140 markets. The company has also begun to execute on its vision of becoming a leader in women’s health, with the recently announced proposed acquisition of Alydia Health.
Driving leadership in women’s health. Organon has a scaled portfolio of contraceptive and fertility brands, anchored by market exclusivity for NEXPLANON (etonogestrel implant), that delivered approximately $1.6 billion in global sales in 2020 and has long-term growth potential. Organon will also broaden its definition of women’s health beyond contraception and fertility to address conditions that are unique to women as well as health issues that disproportionately affect women, placing Organon in an addressable market of more than $60 billion by 2026.
Executing on the commercialization of Biosimilars. Organon will be in a strong position with the products in its current portfolio through its long-standing collaboration with Samsung Bioepis. Growth drivers in Organon’s Biosimilars portfolio are expected to include the continued success of RENFLEXIS (infliximab-abda) in the U.S., the launch of AYBINTIO (bevacizumab) in the EU and HADLIMA (adalimumab-bwwd) in Canada, as well as the anticipated launch of HADLIMA in the U.S. in 2023.
Leveraging the Established Brands portfolio for steady cash flow. The Established Brands business consists of 49 products across a range of therapeutic areas, including respiratory, cardiovascular, dermatology and non-opioid pain, and delivered $4.5 billion of revenue in 2020. This portfolio includes brands beyond their patent loss in most markets, with only modest remaining LOE exposure beyond 2021. The company will look to capitalize on these well-known and recognizable brands in international markets by selectively increasing commercial spend in areas that have the potential to offer solid returns.
Developing a new R&D approach with women at the center. Organon will look across academic centers, as well as early and established companies, to find promising drugs, diagnostics and devices to develop through its global capabilities in clinical development and patient safety, regulatory and medical affairs. Its R&D philosophy is to build a business around patient needs, advancing healthcare options for women that enable them to live their best lives every day.
2021 Investor Day Presenters
Investor Day will feature presentations from the following Merck and Organon executives in order of their appearance:

Rob Davis, President, Merck
Kevin Ali, Chief Executive Officer, Organon
Susanne Fiedler, Chief Commercial Officer, Organon
Simon Holland, Women’s Health, Commercial Lead, Organon
Elisabeth Weis, Fertility, Commercial Lead, Organon
Joe Azzinaro, Biosimilars, Commercial Lead, Organon
Ger Brennan, Established Brands, Commercial Lead, Organon
Sandy Milligan, Head of Research & Development, Organon
Matthew Walsh, Chief Financial Officer, Organon
The full biographies of the speakers can be found at www.merck.com/events/organon-co-investor-day.

Webcast Details
Merck invites shareholders, the investment community, the media and the general public to tune into the webcast of the Investor Day event today from 10:00 am to 12:15 pm EDT. To register for the webcast and view related materials, including presentations and speaker biographies, please visit the website at www.merck.com/events/organon-co-investor-day or listen-in to the audio-only teleconference with the opportunity to ask questions by dialing 1-844-340-4759 or internationally at 1-412-717-9615. A replay and transcript will be available shortly after the completion of the live webcast.

ChromaDex to Present at Benzinga’s Global Small Cap Conference on May 13, 2021

On May 3, 2021 ChromaDex Corp. (NASDAQ: CDXC) reported that is scheduled to participate in a virtual presentation at the Benzinga Small Cap Conference on Thursday, May 13, 2021 at 11:30am ET (8:30am PT) (Press release, ChromaDex, MAY 3, 2021, View Source [SID1234579009]). ChromaDex CEO, Rob Fried, will also be presenting on a panel in the Transformative Healthcare track, entitled "Investing in Longevity Science: The New Drugs & Therapies Designed to Prolong Your Lifespan." The panel is scheduled for Thursday, May 13, 2021 at 1:20pm ET.

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The Global Small Cap Conference is a day dedicated to bridging the gap between Small Cap companies, investors and traders. The event will have multiple days of networking and education in a virtual setting.

A webcast of the company presentation will be posted under the investor relations section of ChromaDex’s website at www.chromadex.com, or can be accessed at View Source A replay of the presentation will be available following the event.

To learn more about small-cap innovation and investing at the Benzinga Global Small Cap Conference, click here.

Exact Sciences to participate in May investor conferences

On May 3, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, MAY 3, 2021, View Source [SID1234579008]).

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BofA Securities Virtual Healthcare Conference
Fireside Chat on Wednesday, May 12, 2021 at 1:15 p.m. EDT

UBS Global Healthcare Virtual Conference
Fireside Chat on Tuesday, May 25, 2021 at 4:00 p.m. EDT
The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

Geron to Announce First Quarter 2021 Financial Results on May 10, 2021

On May 3, 2021 Geron Corporation (Nasdaq: GERN) reported that it will release its first quarter 2021 financial results after the market closes on Monday, May 10, 2021 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, MAY 3, 2021, View Source [SID1234579007]). Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

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A live, listen-only webcast will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the conference call live via telephone by pre-registering online using the following link, View Source Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.

Lantern Pharma Reports First Quarter 2021 Financial Results and Operational Highlights

On May 3, 2021 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform oncology drug discovery and development reported financial results for the first quarter ended March 31, 2021 (Press release, Lantern Pharma, MAY 3, 2021, View Source [SID1234579006]).

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"We are very pleased with our continued rapid progress in expanding and advancing our pipeline of targeted cancer drug candidates and are on pace to launch the Phase 2 trial of LP-300 in non-small cell lung cancer among non-smokers in the third quarter of this year," stated Panna Sharma, President and CEO of Lantern Pharma. "During the first quarter, we dramatically accelerated the pace with which we gather, curate, tag and assemble biologically relevant data for our RADR A.I. platform. Our RADR A.I. platform now exceeds 4.6 billion datapoints, representing a nearly 16-fold increase in the number of datapoints since our IPO in June 2020. RADR grew by approximately 1 billion datapoints per month during the first quarter of 2021. The size and scope of our RADR A.I. platform is opening up new insights and areas of opportunity for the discovery of additional indications for our existing drug candidates, as well as the identification of entirely new drug candidates and new therapeutic indications for existing molecules in the fight against cancer."

"Perhaps most exciting, as our RADR A.I. platform grows, potential partnerships with biopharma companies are now even more clearly in our sights," continued Sharma. "Earlier today, we announced that we have entered into an equity-based collaboration with Actuate Therapeutics to apply the remarkable power of RADR to better understand the mechanism of action of Actuate’s 9-ING-41 drug candidate and utilize these insights to advance a biomarker signature of response and a biomarker guided development strategy. We are excited about the opportunity to continue to build additional value-driven partnerships in the quarters ahead."

The collaboration will focus on leveraging the RADR machine learning technology, large-scale oncology datasets, and the A.I. platform to accelerate key aspects of Actuate’s 9-ING-41 drug candidate, a best-in-class GSK-3β inhibitor in active development in multiple Phase 2 clinical trials, including for pancreatic cancer. The collaboration is expected to start immediately and will potentially generate novel intellectual property that will be jointly owned by the companies. Lantern will receive upfront equity in Actuate Therapeutics subject to meeting certain conditions of the collaboration, as well as development milestones in the form of additional equity if results from the collaboration are utilized in future development efforts.

Lantern is developing four drug candidates and an ADC program across seven disclosed targets, including:

●LP-100 (Irofulven), in a Phase 2 trial for the treatment of metastatic castration resistant prostate cancer (mCRPC) which is out-licensed to Allarity Therapeutics.

●LP-300, a small molecule candidate that is preparing to enter a Phase 2 trial as a combination therapy in non-smokers with Non-Small Cell Lung Cancer (NSCLC).

●LP-184, a small molecule DNA damaging candidate anticipated to enter clinical development in 1H’22, with opportunities in several genomically-defined cancers, including: prostate, pancreatic, glioblastoma multiforme (GBM), atypical teratoid rhabdoid tumors (ATRT) and potentially additional tumors defined by the overexpression of PTGR1.

●LP-284, an alkylating agent in the research optimization stage, that appears to be preferentially active in certain hematologic cancers.

●Antibody Drug Conjugate (ADC) program leveraging RADR A.I. to identify targeted or therapeutic antibodies and aimed at utilizing a unique library of linkers to conjugate with LP-184 and other compounds.

First Quarter 2021 Financial Highlights

-Cash Position: Cash and cash equivalents were $81.4 million as of March 31, 2021 compared to $19.2 million as of December 31, 2020. The increase in cash and cash equivalents reflects the proceeds from our January 20, 2021 follow-on public offering with gross proceeds of $69.0 million.

-R&D Expenses: Research and development expenses were $1,279,037 for the quarter ended March 31, 2021, compared to $137,104 for the quarter ended March 31, 2020. The increase was primarily attributable to increases in research studies, expansion of the company’s research team, and research and development related stock option compensation expense of approximately $116,000 (a non-cash item) for the quarter ended March 31, 2021.

-G&A Expenses: General and administrative expenses were $1,173,258 for the quarter ended March 31, 2021, compared to $340,172 for the quarter ended March 31, 2020. The increase was primarily attributable to expenses associated with operating as a public company and general and administrative related stock option compensation expense of approximately $130,000 (a non-cash item) for the quarter ended March 31, 2021.

-Net Loss: Net losses were $2,452,295 for the quarter ended March 31, 2021, or $0.24 per share, compared to a net loss of $477,276 for the quarter ended March 31, 2020, or $0.24 per share. The net loss includes non-cash expenses related to employee stock options of approximately $246,000 for the quarter ended March 31, 2021.

Mr. Sharma concluded, "We will continue to aggressively advance our portfolio, both clinically and in new preclinical indications, and continue to leverage our A.I. platform to uncover new rescue or repurposing opportunities on our own or with partners. Our team is committed to building Lantern into a best-of-breed biopharma company that transforms the cost, pace and risk of oncology drug development by leveraging insight from our RADR A.I. platform with the experience and expertise of our cancer-focused research team and a roster of collaborations with world-renowned cancer research institutions. Our financial position has never been stronger and our portfolio of targeted oncology drug candidates is positioned to deliver significant ongoing value for shareholders."