On January 09, 2023 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the company’s key 2023 milestones ahead of its presentation at J.P. Morgan’s 41st annual healthcare conference this week (Press release, Cogent Biosciences, JAN 9, 2023, View Source [SID1234626046]).

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"We made tremendous progress in 2022 demonstrating bezuclastinib’s differentiated clinical profile in Systemic Mastocytosis while advancing an improved formulation of bezuclastinib through clinical studies that enabled the start of our global Phase 3 GIST trial," said Andrew Robbins, President and CEO of Cogent Biosciences. "In 2023, we look forward to continuing the rapid development of bezuclastinib toward leadership positions in both Systemic Mastocytosis and GIST, while we enhance our impressive, growing portfolio of targeted cancer therapeutics. By the end of 2023, we expect to have a portfolio of five distinct programs which will position us as a leader in precision medicine."

In 2023, the Company plans to achieve the following milestones:

Bezuclastinib – Systemic Mastocytosis (SM)

Phase 2 APEX trial – announce results from planned Part 1 analysis including approximately 25-30 AdvSM patients in mid-2023, enabling dose selection for Part 2 trial expansion.

Phase 2 SUMMIT trial – present initial clinical data in patients with NonAdvSM in the second half of 2023. Clinical results will include safety/tolerability, pharmacokinetics and measures of clinical activity.

Initiate clinical investigation of bezuclastinib in SM patients with associated hematologic neoplasms (SM-AHN), allowing for concomitant use of AHN-directed therapies.
Bezuclastinib – Gastrointestinal Stromal Tumors (GIST)

Present updated clinical results from refractory GIST patients in the lead-in cohort of the Phase 3 PEAK trial of the pan-KIT mutant regimen, bezuclastinib plus sunitinib, during the first half of 2023.

Enrollment in the Phase 3 PEAK trial for 2nd-line GIST patients remains on track, with expansion to over 100 global clinical sites expected before the end of this year.
Preclinical Pipeline

Select FGFR2-mutant selective clinical candidate and initiate IND-enabling GLP toxicology studies in the first half of 2023. This program is designed as a potential best-in-class, reversible, FGFR1-sparing, potent pan-FGFR2 mutant inhibitor that includes coverage of both key gatekeeper and molecular brake mutations (V564I, N549K).

Select ErbB2-mutant selective clinical candidate in the second half of 2023. This program is designed as an EGFR-sparing, CNS-penetrant ErbB2 inhibitor that includes coverage of key mutations (YVMA, S310F, V842I, L755S) inadequately addressed by currently approved therapies.

Present initial preclinical data on two additional novel target programs with best-in-class potential out of the Cogent Research Team’s labs during 2023.
JPM Presentation Details
Cogent will participate in a presentation and Q&A session at the J.P. Morgan 41st Annual Healthcare Conference in San Francisco on Thursday, January 12, 2023, beginning at 7:30 a.m. PT (10:30 p.m. ET). A live webcast will be accessible in the "Investors & Media" section of the company’s website, www.cogentbio.com, and will be archived for 30 days following the event.

On January 09, 2023 Cerus Corporation (Nasdaq: CERS) reported preliminary product revenue for the fourth quarter and full-year 2022 and provided product revenue guidance for full-year 2023 (Press release, Cerus, JAN 9, 2023, View Source [SID1234626045]).

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Cerus’ unaudited preliminary product revenue for the fourth quarter of 2022 totaled $44.0 million, representing an increase of 10% over the $39.9 million recognized during the fourth quarter of 2021. The Company expects its unaudited preliminary full-year 2022 product revenue to be $162.0 million, which would be at the top end of the Company’s 2022 product revenue guidance range of $160-$162 million and reflect year-over-year growth of 24%. These preliminary full-year product revenue results have not been audited and are subject to change.

"Cerus’ commercial execution in the fourth quarter of 2022 was consistent with our strong performance throughout the first three quarters of the year. We believe the continued growth in demand for the INTERCEPT Blood System, particularly in the U.S., reflected the ongoing resiliency of our business as well as the integral role played by pathogen reduction in safeguarding the global blood supply," stated William "Obi" Greenman, Cerus’ president and chief executive officer.

"Given the current macroeconomic environment, Euro to U.S. dollar exchange rates at or near parity, heightened volatility and resulting uncertainty, we expect 2023 to be a bridge year for the Company as we continue to build the foundation for broader INTERCEPT adoption," continued Greenman. "While we may see the uncertainty and trepidation persist through 2023, we believe these will be most acutely felt during the first quarter as customers assess the year prior to entering into more normalized and consistent operations." As a result of these factors, the Company expects full-year 2023 product revenue will be in the range of $165-$170 million.

"We view the expanded adoption of our INTERCEPT Fibrinogen Complex product and the roll-out of the INTERCEPT Blood System in new geographies as drivers that, while challenging to forecast during this uncertain time, should become clearer throughout the course of the year and provide incremental growth when the macroeconomic landscape settles down," added Greenman.

Cerus will provide complete fourth quarter and full-year 2022 financial results and host a call to discuss both 2022 results and 2023 expectations in late February.

On January 09, 2023 Calithera Biosciences, reported that its Board of Directors has determined, after extensive consideration of potential strategic alternatives, that it is in the best interests of its shareholders to dissolve the Company and liquidate its assets, following an orderly wind down of the company’s operations (Press release, Calithera Biosciences, JAN 9, 2023, View Source [SID1234626042]). In order to reduce costs and in connection with the planned dissolution, Calithera is discontinuing all clinical development programs and reducing its workforce, including the termination of most employees by the end of the first quarter.

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"The Board of Directors and management devoted substantial time and effort in identifying and pursuing various opportunities, but we were unable to complete a transaction that would allow us to continue the development of our clinical programs and enhance shareholder value," stated Susan Molineaux, PhD, president and chief executive officer of Calithera. "Importantly, I would like to sincerely thank our employees and others who have supported Calithera over the years. We appreciate your partnership and participation, and we truly wish the outcome was different today."

Plan of Liquidation and Dissolution

The Board of Directors has unanimously approved the dissolution and liquidation of the Company, subject to shareholder approval, pursuant to a Plan of Complete Liquidation and Dissolution (the "Plan of Dissolution"). The Company intends to call a special meeting of its shareholders in the first calendar quarter of 2023 to seek approval of the Plan of Dissolution and will file proxy materials relating to the special meeting with the Securities and Exchange Commission (the "SEC") as soon as practical. The Plan of Dissolution contemplates an orderly wind down of the Company’s business and operations. If the Company’s shareholders approve the Plan of Dissolution, the Company intends to file a certificate of dissolution, delist its shares of common stock from The Nasdaq Global Select Market, satisfy or resolve its remaining liabilities and obligations, including but not limited to contingent liabilities and claims and costs associated with the dissolution and liquidation, make reasonable provisions for unknown claims and liabilities, and attempt to convert all of its remaining assets into cash or cash equivalents. Upon the filing of the certificate of dissolution, the Company intends to cease trading in its common stock, close its stock transfer books and discontinue recording transfers of shares of its capital stock, in accordance with applicable law. The Company will establish a reserve, which will be used to pay all expenses (including operating expenses up until the filing of the certificate of dissolution) and other known, non-contingent liabilities and obligations, and will include reasonable provision for future expenses of liquidation and contingent and unknown liabilities as required by Delaware law. The Company currently expects that its existing capital resources together with the anticipated net proceeds from the sale of certain clinical assets will enable it to meet its remaining liabilities and obligations with sufficient reserves. However, in light of the liquidation preference held by the holder of its Series A convertible preferred stock, even if all of the Company’s assets are converted to cash or cash equivalents, the Company does not anticipate that the liquidation preference will be satisfied and therefore no liquidating distributions are expected to be made to the holders of its common stock. The Company will provide an estimate of any such amount that may be distributed to the holder of its Series A convertible preferred stock in the proxy materials to be filed with the SEC. The amount actually distributable, however, may vary substantially from any estimate provided by the Company based on a number of factors.

IMPORTANT ADDITIONAL INFORMATION

In connection with the proposed Plan of Dissolution, the Company intends to file with the SEC a proxy statement and other relevant materials. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT, ANY AMENDMENTS OR SUPPLEMENTS THERETO, ANY OTHER SOLICITING MATERIALS AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PLAN OF DISSOLUTION AND RELATED MATTERS OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT WHEN IT BECOMES AVAILABLE BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION ABOUT CALITHERA BIOSCIENCES, INC. THE PLAN OF DISSOLUTION AND RELATED MATTERS. Shareholders may obtain a free copy of the proxy statement and the other relevant materials (when they become available), and any other documents filed by the Company with the SEC, at the SEC’s website at View Source or on the "Investors" section of Calithera’s website at www.calithera.com.

On January 9, 2023 Erasca presented its corporate presentation (Presentation, Erasca, JAN 9, 2023, View Source [SID1234626056]).

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On January 9, 2023 Eagle pharmaceuticals presented its corporate presentation (Presentation, Eagle Pharmaceuticals, JAN 9, 2023, View Source [SID1234626053]).

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