On January 5, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) t reported preliminary Monjuvi U.S. net product sales for the full year of 2022 and reported its financial guidance for 2023 (Press release, MorphoSys, JAN 5, 2023, View Source [SID1234625905]). In this context, MorphoSys reduced its financial liability from the collaboration with Incyte and credited finance income accordingly.

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Preliminary Monjuvi (tafasitamab-cxix) U.S. net product sales are US$ 25.3 million (€ 24.0 million) for the fourth quarter and US$ 89.4 million (€ 84.9 million) for the full year of 2022. Fourth quarter and full year 2022 results will be published on March 15, 2023. For the full year of 2023, MorphoSys expects Monjuvi U.S. net product sales in the range of US$ 80 to 95 million.

As a result of changes in Monjuvi product sales expectations, the balance sheet item "Financial Liabilities from Collaborations" is reduced from € 580 million (balance as of September 30, 2022) to approximately € 220 million (balance as of December 31, 2022; unaudited). Finance income is credited with the difference between the two amounts. The balance in "Financial Liabilities from Collaborations" reflects an accounting view of expected future profits from the net product sales of Monjuvi in the U.S. in relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) owed to our partner Incyte. The reduction in Financial Liabilities from Collaborations has no impact on cash.

"Patients living with relapsed or refractory diffuse large B-cell lymphoma continued to benefit from Monjuvi in 2022, as we saw an increase in sales of our medicine in the fourth quarter and a preliminary final sales total in line with our updated guidance," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "As we enter into the third year post-launch, we set our sales guidance for 2023 and longer-term projections for Monjuvi in its approved indication to reflect the ongoing and future impact of competitive activity. The team remains highly engaged to ensure continued awareness and use of Monjuvi as the only NCCN-preferred in-practice, out-patient immunotherapy for all appropriate patients, while preparing for our longer-term opportunities for pelabresib in first-line myelofibrosis and Monjuvi for first-line DLBCL."

Full Year 2023 Financial Guidance:

2023 Financial Guidance 2023 Guidance Insights
Monjuvi U.S. net product sales US$ 80m to 95m 100% of Monjuvi U.S. net product sales are recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte.
Gross margin for Monjuvi U.S. net product sales 75% to 80% 100% of Monjuvi U.S. product cost of sales are recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte.
R&D expenses € 290m to 315m 2023 anticipated to be incrementally higher than 2022 due to the expansion of the pelabresib development program.
SG&A expenses € 140m to 155m 45% to 50% of mid-point of SG&A expenses represent Monjuvi U.S. selling costs of which 100% are recorded in MorphoSys’ income statement. Incyte reimburses MorphoSys for half of these selling expenses.

Additional information related to 2023 Financial Guidance:

Tremfya royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys, as 100% of the royalties will be passed on to Royalty Pharma.

MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S.

MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2023.

MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the "Licenses, milestones and other" category in MorphoSys’ income statement.

These sales result in a zero gross profit/margin. As such, MorphoSys does not provide guidance for these sales.

On January 5, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that Walter Klemp, President and Chief Executive Officer of Moleculin, will present at the Virtual Investor 2023 Companies to Watch Event on Tuesday, January 17, 2023 at 9:00 AM ET (Press release, Moleculin, JAN 5, 2023, View Source [SID1234625904]).

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A live video webcast of the presentation will be available on the Events page of the Investors section of the Company’s website (moleculin.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On January 5, 2023 MannKind Corporation (Nasdaq: MNKD) a company focused on the development and commercialization of innovative therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will present at the 2023 Annual J.P. Morgan Healthcare Conference on Thursday, January 12, 2023 at 11:15 AM PST at the Westin St. Francis Hotel in San Francisco, California (Press release, Mannkind, JAN 5, 2023, View Source [SID1234625903]).

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Those interested in listening to the webcast may do so by visiting the Company’s website at Investors/Events & Presentations or View Source The webcast will also be archived and available for replay

On January 5, 2023 Invectys, Inc. "Invectys", a clinical-stage immunotherapy company headquartered in Houston and dedicated to the development of a new generation of cell therapy products for cancer patients, reported that Praveen Tyle, Ph.D., President and CEO of Invectys, will participate in the 2023 edition of the JP Morgan Healthcare Meeting on January 9-12, 2023 (Press release, Invectys, JAN 5, 2023, View Source [SID1234625901]). In addition to the main meeting, Dr. Tyle will also attend the 2023 BIO One-on-One partnering meetings live from January 9-12 at the San Francisco Marriott Marquis.

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On Jnauary 5, 2023 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, reported its strategic priorities for the upcoming two years as the Company enters its next phase of pipeline execution and platform innovation (Press release, Intellia, JAN 5, 2023, View Source [SID1234625900]).

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2023 – 2024 Strategic Priorities

Initiate global pivotal trials for Intellia’s first two investigational in vivo CRISPR-based therapies, NTLA-2001 for transthyretin (ATTR) amyloidosis and NTLA-2002 for hereditary angioedema (HAE);

Advance new platform capabilities to the clinic, including CRISPR-based in vivo targeted gene insertion and a first-of-its-kind allogeneic cell engineering solution designed to avoid NK cell-mediated rejection;

Lead the development of new gene editing and delivery modalities, compatible with its modular platform, which will extend Intellia’s position of technological leadership and drive future pipeline growth.

"2022 proved to be another outstanding year for Intellia, with several significant clinical milestones achieved across our pipeline, further reinforcing the ability of our modular CRISPR genome editing platform to target a broad range of diseases," said Intellia President and Chief Executive Officer John Leonard, M.D. "These accomplishments reflect steady execution against our core strategy: to harness the immense power of genome editing, both for in vivo and ex vivo applications. As we look ahead, our highest priority will be to prepare for the initiation of global pivotal trials for our first two investigational in vivo CRISPR-based therapies, NTLA-2001 for ATTR amyloidosis and NTLA-2002 for hereditary angioedema. As these programs continue to progress, we believe we are moving closer to setting a new standard of care for people living with these and other serious diseases. In addition, we are advancing the next wave of platform capabilities, such as in vivo gene insertion and our proprietary allogeneic solution. Importantly, while the possibilities to apply our industry-leading genome editing technology are expansive, we are taking a disciplined approach with our portfolio by deploying resources on high-impact opportunities and collaborating with a network of other scientific leaders to expand the applications of our innovative technologies."

Based on these strategic priorities, which will be the Company’s focus over the next two years, Intellia anticipates reaching the following key program milestones in 2023:

In Vivo Programs

NTLA-2001 for ATTR amyloidosis:

Submit an IND application in mid-2023 to enable inclusion of U.S. sites in a pivotal study of NTLA-2001 for patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM).

Present additional clinical data from the ongoing Phase 1 study of NTLA-2001 in 2023.

Initiate a global pivotal NTLA-2001 trial for ATTR-CM by year-end 2023, subject to regulatory feedback.
Prepare for a Phase 3 study of NTLA-2001 for the treatment of ATTR amyloidosis with polyneuropathy (ATTRv-PN), including discussions with regulatory authorities.

NTLA-2002 for HAE:

Initiate Phase 2 portion of the ongoing NTLA-2002 Phase 1/2 study in 1H 2023.

Submit an IND in 1H 2023 to support inclusion of U.S. sites in the Phase 2 study of NTLA-2002.

Present additional clinical data from the ongoing first-in-human study of NTLA-2002 in 2023.

Alpha-1 antitrypsin deficiency (AATD) franchise:

Submit an IND or IND-equivalent application for NTLA-3001, Intellia’s wholly owned insertion candidate in development for AATD-associated lung disease, in 2H 2023.

Complete IND-enabling activities for NTLA-2003, a wholly owned knockout candidate for AATD-associated liver disease, by year-end 2023.

Prevalent diseases:

Progress one new in vivo development candidate, nominated in 2022, for the treatment of an undisclosed prevalent condition.

Ex Vivo Programs

NTLA-6001 for CD30+ Lymphomas:

Identify collaboration opportunities to advance development of NTLA-6001.

Additional ex vivo candidates:

Advance multiple programs, wholly owned or in collaboration with partners, utilizing allogeneic platform.

Platform Innovation

Advance novel gene editing technologies, including DNA writing, and delivery to other tissues outside of the liver.

Cash Position

Intellia ended the fourth quarter of 2022 with approximately $1.3 billion in cash, cash equivalents and marketable securities.