On January 11, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that its Chief Executive Officer, Dr. Adi Hoess, will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 7:30 a.m. Eastern Standard Time (Press release, Affimed, JAN 11, 2021, View Source [SID1234573831]).

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A live webcast of the presentation may be accessed on Affimed’s website at View Source and will be available for 30 days following the event. For more information or to schedule a one-on-one meeting with Affimed management, please contact Alex Fudukidis via email at [email protected] or phone at +1 (917) 436-8102.

On January 11, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported its strategic priorities and expected upcoming milestones (Press release, Syros Pharmaceuticals, JAN 11, 2021, View Source [SID1234573830]).

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"Syros is rapidly accelerating toward becoming a commercial-stage company through three strategic priorities: advancing franchises in targeted hematology and selective CDK inhibition, as well as leveraging a robust gene control discovery engine to fuel our long-term growth," said Nancy Simonian, M.D., Syros’ Chief Executive Officer. "As we enter the new year, we are well-positioned to execute against each of these strategic priorities. We plan to launch three clinical trials across our portfolio of targeted hematology therapies in patients with higher-risk MDS, AML and APL, indications where we have the opportunity to set new standards of care."

"In parallel, we continue to build on our leadership in selective CDK inhibition, where we believe we can deliver highly selective product candidates with transformative potential for difficult-to-treat cancers. We are on track to report additional dose-escalation data, including clinical activity, from our Phase 1 trial of SY-5609 in the third quarter and move into the expansion phase of the trial in the second half of the year. These milestones bring us closer to our ultimate goal of bringing targeted therapies to market that provide profound benefits for patients with diseases that have eluded other approaches."

Expected Milestones

SY-1425: Oral RARα agonist

Initiate Phase 3 trial of SY-1425 in combination with azacitidine in the first quarter of 2021 in RARA-positive patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).
Initiate randomized Phase 2 trial of SY-1425 in combination with venetoclax and azacitidine in the second half of 2021 in RARA-positive newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard intensive chemotherapy.
SY-2101: Oral arsenic trioxide (ATO)

Initiate dose confirmation study of SY-2101 in the second half of 2021.
Initiate Phase 3 trial in patients with newly diagnosed acute promyelocytic leukemia (APL) in 2022.
SY-5609: Oral CDK7 inhibitor

Report additional dose-escalation data, including clinical activity data, in the third quarter of 2021 from the ongoing Phase 1 trial of SY-5609 in patients with breast, colorectal, lung, ovarian and pancreatic cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations.
Initiate expansion portion of Phase 1 trial in the second half of 2021.
Gene control discovery engine

Expect to nominate next development candidate in 2022.
Financial Guidance
Syros ended the year with approximately $174 million in cash, cash equivalents and marketable securities1, which the company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2022.

On January 11, 2021 Mirati Presented the Corporate Presentation (Presentation, Mirati, JAN 11, 2021, View Source [SID1234573829]).

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On January 11, 2021, Moleculin Biotech, Inc. (the "Company") presented the corporate presentations (Press release, Moleculin, JAN 11, 2021, View Source [SID1234573828]).

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On January 11, 2021 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported preliminary unaudited financial results for the fourth quarter and year ended December 31, 2020, and provided business updates (Press release, Vericel, JAN 11, 2021, View Source [SID1234573827]).

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Preliminary Unaudited Fourth-Quarter and Full-Year 2020 Financial Results
Preliminary total net revenues for the fourth-quarter 2020 are expected to be in the range of $44.9-$45.4 million, with MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue in the range of $34.4-$34.9 million, Epicel (cultured epidermal autografts) net revenue of approximately $9.6 million, and NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) revenue of approximately $1 million related to the U.S. Biomedical Advanced Research and Development Authority’s (BARDA) procurement of NexoBrid for emergency response preparedness.

Preliminary total net product revenues for the full-year 2020 are expected to be in the range of $123.9-$124.4 million, with MACI net revenue in the range of $94.1-$94.6 million, Epicel net revenue of approximately $27.5 million, and NexoBrid revenue of approximately $2.2 million related to the BARDA procurement.

Cash and investments increased by approximately $14.5 million in the fourth quarter. As of December 31, 2020, the company had approximately $100 million in cash and investments and no debt, compared to $79.0 million as of December 31, 2019.

Business Highlights and Updates

Record fourth-quarter and full-year total net revenues;
Record quarterly and full-year MACI implants and net revenue;
Record fourth-quarter and full-year Epicel grafts and net revenue, and the second highest quarterly Epicel grafts and revenue in history;
Received MACI biopsies from approximately 1,500 surgeons in 2020, up from approximately 1,400 surgeons in 2019;
Record quarterly high in the number of surgeons taking MACI biopsies in the fourth quarter; and
Double-digit growth in MACI biopsies in the fourth quarter, achieving a record quarterly high and a record monthly high in December.
"We delivered strong financial and operational results in the fourth quarter and for the full year, including record product volumes and revenue for both MACI and Epicel for the year," said Nick Colangelo, President and CEO of Vericel. "Epicel performance was very strong in the fourth quarter, with revenue growing over 60% for the quarter. MACI performance was in line with our expectations through mid-December. However, due to the recent surge in COVID-19 cases in the United States, the scheduling of MACI pipeline cases for the last two weeks of December slowed compared to historical trends and there was an increase in case cancellations during that period. We expect, based on our experience earlier this year, that the majority of those MACI cases, which represent approximately $2 million in revenue, will move forward in 2021. Moreover, the underlying growth drivers for MACI were in line with our expectations, which we believe will drive strong revenue and profitability growth in 2021."

The company will host a webcast and conference call to discuss its fourth quarter 2020 financial results and business highlights on February 24, 2020, at 8:30am Eastern Time. Webcast information can be found on the events and presentation section of the Investor Relations website at View Source