On February 12, 2024 Sana Biotechnology, Inc. (Nasdaq: SANA), a company focused on changing the possible for patients through engineered cells, reported that it has closed its underwritten upsized public offering of 21,772,728 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 4,500,000 additional shares of its common stock, at a price to the public of $5.50 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 12,727,272 shares of its common stock at a price to the public of $5.4999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant (Press release, Sana Biotechnology, FEB 12, 2024, View Source [SID1234639985]). All of the shares and pre-funded warrants were sold by Sana. The gross proceeds from the offering were approximately $189.75 million before deducting underwriting discounts and commissions and other offering expenses.

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Morgan Stanley, J.P. Morgan, Goldman Sachs & Co. LLC, and BofA Securities acted as joint book-running managers for the offering.

The offering was made pursuant to a Registration Statement on Form S-3, including a base prospectus, previously filed with and declared effective by the SEC. Sana has filed with the SEC the final prospectus supplement and accompanying prospectus relating to the offering. These documents can be accessed for free through the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Goldman Sachs & Co. LLC, Attn: Prospectus Department, at 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; or BofA Securities, Attn: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of any such state or jurisdiction.

On February 12, 2024 Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, reported an upfront cash payment and equity investment from TG Therapeutics, Inc. (Nasdaq: TGTX) for an exclusive license to develop Azercabtagene Zapreleucel (azer-cel) for autoimmune diseases, and other indications outside of cancer (Press release, Precision Biosciences, FEB 12, 2024, View Source [SID1234639984]). This is the first in a series of payments, with Precision to receive a total of $17.5 million in upfront and potential near-term payments as part of the consideration for this license.

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In exchange for global rights to azer-cel for autoimmune diseases and indications outside of cancer, Precision has received an upfront payment totaling $7.5 million, consisting of cash and the purchase of 2,920,816 shares of Precision common stock by TG Therapeutics at a price of $0.77 per share, a 100% premium to the 30-day volume-weighted average price (VWAP) prior to purchase.

Precision will also receive an additional $2.5 million within 11 months, as an equity investment in Precision’s common stock at 100% premium to the then 30-day VWAP prior to purchase. Upon the achievement of certain near-term clinical milestones, Precision will also receive an additional $7.5 million payment. Precision is eligible to receive up to $288 million in milestone payments in addition to high-single-digit to low-double-digit royalties on net sales.

Precision expects that these recent payments from its azer-cel transactions, along with existing cash and cash equivalents, expected operational receipts, continued fiscal and operating discipline, and availability of Precision’s at-the-market (ATM) facility will extend Precision’s cash runway into the first half of 2026, through phase 1 clinical readouts for its wholly owned programs.

On February 12, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported the initiation of a REM-001 15-patient clinical trial (NCT05374915) in cutaneous metastatic breast cancer (CMBC) patients (Press release, Kintara Therapeutics, FEB 12, 2024, View Source [SID1234639983]).

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This open label 15-patient study in CMBC patients is evaluating REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate (bORR) (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24.

In June 2023, Kintara was awarded a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001 in CMBC. This grant will cover the majority of the costs to run this clinical study.

"We are encouraged by the extensive data from prior REM-001 therapy trials supporting its strong efficacy in CMBC patients, providing us with an opportunity to address a significant unmet medical need," said Robert E. Hoffman, President and CEO of Kintara. "With an 80% complete response rate for evaluable lesions in CMBC patients observed in previous late-stage clinical trials and the support of the NIH, along with the FDA’s Fast Track Designation, we are confident in the potential of REM-001 to help CMBC patients."

"CMBC is a devastating disease with limited treatment options for patients," said Alina Markova, M.D., Section Head, General Dermatology and Oncodermatology at Memorial Sloan Kettering Cancer Center and Principal Investigator of the REM-001 15-patient study. "I am looking forward to testing the therapeutic potential of REM-001 in this trial and bringing novel therapies to CMBC patients to improve their quality of life."

Cutaneous metastases can develop with any metastatic cancer but are believed to occur most frequently in metastatic breast cancer. A 2003 meta-analysis of over 20,000 metastatic cancer patients found that 24% of the breast cancer patients included in the analysis had developed cutaneous metastases, which was the highest rate of any cancer type. Based on a 2017 analysis, the current prevalence of metastatic breast cancer in the United States is estimated to be over 168,000. Accordingly, the prevalence of CMBC may be in excess of 40,000 cases annually in the United States.

On February 12, 2024 AbbVie (NYSE: ABBV) reported that it has completed its acquisition of ImmunoGen (NASDAQ: IMGN) (Press release, ImmunoGen, FEB 12, 2024, View Source [SID1234639982]). With the completion of the acquisition, ImmunoGen is now part of AbbVie.

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"Together with ImmunoGen, we have the potential to continue redefining the standard of care for those living with cancer," said Robert A. Michael, president and chief operating officer, AbbVie. "The addition of ImmunoGen’s treatment for ovarian cancer will accelerate our ability to help patients today, expand our oncology pipeline and drive long-term revenue growth well into the next decade. I want to thank ImmunoGen for their efforts to advance science for patients and we look forward to welcoming our new colleagues to AbbVie."

ELAHERE (mirvetuximab soravtansine-gynx) is the first and only antibody-drug conjugate (ADC) approved by the U.S. Food and Drug Administration (FDA) in ovarian cancer. The FDA granted accelerated approval for ELAHERE in folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) patients based on response data. Results from a confirmatory trial currently under review by the FDA show that ELAHERE is the first targeted agent to offer a survival benefit in PROC, with label expansion opportunities across larger segments of the ovarian cancer market.

ImmunoGen’s follow-on pipeline of ADCs further builds on AbbVie’s existing solid tumor pipeline of novel targeted therapies and next-generation immuno-oncology assets, which have the potential to create new treatment possibilities across multiple solid tumors and hematologic malignancies. Through focused R&D efforts, AbbVie has developed novel ADC technology and has unique strengths in antibody engineering, drug linker chemistry and toxin research. AbbVie and ImmunoGen’s combined capabilities represent an opportunity to deliver potentially transformative ADC therapies to patients.

ImmunoGen’s investigational Phase 1 asset, IMGN-151, is a next-generation FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications.

Pivekimab sunirine, currently in Phase 2, is an investigational anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN.

For additional background on the acquisition, please read the announcement press release here and view AbbVie’s investor presentation here.

Financial Terms

AbbVie has acquired all outstanding ImmunoGen common stock for $31.26 per share. It is expected that ImmunoGen’s common stock will cease to trade on the NASDAQ stock exchange prior to market open on February 12, 2024. AbbVie expects its acquisition of ImmunoGen to be accretive to AbbVie’s diluted EPS beginning in 2027 and significantly accretive over the long-term.

Full-Year 2024 Outlook

AbbVie is reaffirming its previously issued 2024 full-year adjusted diluted EPS guidance range of $11.05-$11.25. This guidance now includes a $0.42 per share dilutive impact related to the completed ImmunoGen acquisition, as well as the pending Cerevel Therapeutics acquisition, which is anticipated to close in mid-2024. AbbVie’s 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2024, as both cannot be reliably forecasted.

AbbVie is updating its previously issued 2024 first-quarter adjusted diluted EPS guidance range from $2.30-$2.34 to $2.26-$2.30. This guidance now includes a $0.04 per share dilutive impact related to the ImmunoGen acquisition. AbbVie’s 2024 first-quarter adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred in the quarter, as both cannot be reliably forecasted.

About ELAHERE (mirvetuximab soravtansine-gynx)

ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The prescribing information includes a boxed warning. ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. Administer prophylactic artificial tears and ophthalmic topical steroids. Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose. Discontinue ELAHERE for Grade 4 ocular toxicities.

Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

Please see full Prescribing Information, including Boxed Warning for ELAHERE.

On February 12, 2024 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the independent Data Monitoring Committee (DMC) recommended continuation of the pivotal Phase 3 trial (PRESERVE 2), evaluating trilaciclib in combination with gemcitabine and carboplatin for the first line treatment of metastatic triple negative breast cancer (mTNBC), to the final analysis (Press release, G1 Therapeutics, FEB 12, 2024, View Source [SID1234639981]). This final analysis evaluating Overall Survival (OS) is estimated to occur in the third quarter of 2024 and will be conducted on the intent-to-treat (ITT) population. The DMC did not express any concerns regarding safety or recommend any other changes to the study. G1 remains blinded to all data as the early stopping criteria were not met during the interim analysis.

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"We remain confident in the ability of trilaciclib to ultimately achieve the OS primary endpoint based on the robust survival benefit demonstrated in the prior randomized Phase 2 study, which continued to meaningfully increase over time as patients received subsequent therapies, as well as the increased statistical power for the final analysis of this pivotal study," said Jack Bailey, Chief Executive Officer at G1 Therapeutics. "While a positive interim analysis would have enabled us to bring this therapy to patients in need sooner, we look forward to completing the study and potentially making this meaningful new treatment option available to patients with this highly aggressive form of breast cancer as early as next year."

Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during cytotoxic therapy to improve patient outcomes. PRESERVE 2 is a global, multi-center, randomized placebo-controlled, line extension pivotal Phase 3 trial of trilaciclib in patients with locally advanced unresectable or metastatic TNBC. Patients meeting eligibility requirements were randomized 1:1 to receive either trilaciclib or placebo administered prior to first-line gemcitabine and carboplatin (GCb). The regimen is given intravenously (IV) on Days 1 and 8 in 21-day cycles. Treatment is administered until disease progression.

About Triple Negative Breast Cancer (TNBC)
Breast cancer is the most commonly diagnosed cancer worldwide, with over 2.3 million new cases each year. According to the American Cancer Society, nearly 300,000 new cases of invasive breast cancer are diagnosed annually in the U.S. Triple negative breast cancer makes up approximately 15-20% of such diagnosed breast cancers. TNBC is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. Because mTNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. Instead, treating mTNBC typically involves chemotherapy, radiation, and surgery. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer. In general, survival rates tend to be lower with mTNBC compared to other forms of breast cancer, and mTNBC is also more likely than some other types of breast cancer to return after it has been treated, especially in the first few years after treatment. It also tends to be higher grade than other types of breast cancer.