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On July 22, 2021 Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported the pricing of its upsized initial public offering of 19,000,000 shares of common stock at a public offering price of $16.00 per share (Press release, Caribou Biosciences, JUL 22, 2021, View Source [SID1234585132]). All of the shares of common stock are being offered by Caribou. The gross proceeds of the offering, before deducting underwriting discounts and commissions, and other offering expenses payable by Caribou, are expected to be $304.0 million. In addition, Caribou has granted the underwriters a 30-day option to purchase up to an additional 2,850,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The shares are expected to begin trading on the Nasdaq Global Select Market on July 23, 2021, under the ticker symbol "CRBU." The offering is expected to close on or about July 27, 2021, subject to the satisfaction of customary closing conditions.

BofA Securities, Citigroup, and SVB Leerink are acting as joint book-running managers for this offering.

A registration statement relating to the offering has been declared effective by the U.S. Securities and Exchange Commission (the "SEC") on July 22, 2021. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (800) 831-9146 or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]. Copies of the final prospectus, when available, related to the offering will also be accessible through the SEC’s website at www.sec.gov.

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

This press release contains statements that constitute "forward-looking statements" and include, without limitation, statements regarding Caribou’s expectations with respect to the commencement of trading of its shares on the Nasdaq Global Select Market and the size, completion and timing of the closing of the initial public offering. No assurance can be given that the offering discussed above will be completed on the terms or timing described in this release, or at all. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s registration statement and preliminary prospectus filed with the SEC. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

On July 22, 2021 ImmPACT Bio USA, Inc., a company developing novel cell therapies for treating cancer, reported its merger with Kalthera, Inc., a biotechnology company (Press release, ImmPACT-Bio, JUL 22, 2021, View Source [SID1234585117]).

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Kalthera is currently progressing a clinical trial at the University of California, Los Angeles (UCLA) Jonsson Comprehensive Cancer Center with a pioneering bispecific chimeric antigen receptor (CAR) T-cell immunotherapy candidate targeting CD19/CD20. Early results indicated the bispecific CAR T-cell candidate is safe and effective in patients with relapsed or refractory B-cell lymphoma. After a median follow up of up to nine months, six of the seven (86%) patients in the trial have ongoing complete remission.

"Results from this bispecific CAR T-cell candidate are very promising, and that is exactly why we’re so thrilled to work with the brilliant minds at Kalthera," said Rick Kendall, Ph.D., president and CEO of ImmPACT Bio. "ImmPACT Bio is developing cutting-edge CAR T-cell platform technologies to address the key challenges for current cell therapies in oncology – including on-target off-tumor toxicities, antigen escape, and the immunosuppressive microenvironment. Kalthera’s promising clinical program and world-class CAR engineering expertise will help ImmPACT Bio move forward as a clinical-stage company and bring us one step closer to delivering new and potentially life-changing cancer therapies."

Kalthera was founded by Yvonne Chen, Ph.D., Antoni Ribas, M.D., Ph.D., Cristina Puig Saus, Ph.D., and Jim Johnston, Ph.D., and emerged from UCLA.

"We’re proud to join ImmPACT Bio, a company that shares our mission and provides us with the resources to better address current issues with CAR T-cell therapies. Our partnership promises to deliver safe and effective next-generation therapies to patients with cancer," said Dr. Johnston, CEO of Kalthera. "ImmPACT Bio has a highly experienced team and a promising pipeline, and we look forward to advancing more therapies into the clinic to create value for patients."

ImmPACT Bio is backed by OrbiMed, Novartis Venture Fund, Johnson & Johnson Innovation – JJDC, Inc., Takeda Ventures, Inc., RM Global Partners (RMGP) BioPharma Investment Fund, Bukwang Pharmaceutical, Hayan Health Networks, Inc., and JVC Investment Partners.

Dr. Johnston will join the ImmPACT Bio leadership team, while Drs. Chen and Ribas, will join the Company’s scientific advisory board and Dr. Puig Saus will serve as a key consultant. Drs. Chen and Johnston will also join the board of directors of the combined company. Early next year, ImmPACT Bio plans to move into a new facility in the Los Angeles biotech hub that will support the development of manufacturing capabilities for clinical programs.

On July 22, 2021 LUMICKS, a leading next generation life science tools company renowned for its innovative platforms for Dynamic Single-Molecule and Cell Avidity analysis, reported that it has installed its ground-breaking z-Movi Cell Avidity Analyzer at INmune Bio (NASDAQ: INMB) (Press release, INmune Bio, JUL 22, 2021, View Source [SID1234585116]).

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INmune Bio is a clinical stage biotechnology company developing new therapies that modulate the innate immune system to treat cancer and neurodegenerative diseases, such as Alzheimer’s. Its Natural Killer Cell Priming Platform, INKmune is a "pseudokine" which drives a patient’s own natural killer (NK) cells to memory-type NK cells which kill persistent tumors that survive initial treatments.

INmune Bio is employing the z-Movi cell avidity analysis platform to demonstrate that the mechanism of action of the tumor-priming is the increase in NK cell:tumor cell avidity. Early data acquired by the z-Movi support their hypothesis that increased cell avidity enhances NK cell killing of tumor cells. This allows screening of batches of INKmune for potency and provides a potential biomarker of in vivo activity by measuring the tumor avidity of NK cells isolated from patients before and after INKmune treatment.

"The z-Movi is the first high throughput tool I have seen to reliably measure cell:cell avidity, allowing us to dissect the temporal nature of the formation of NK cell:tumor cell synapse as well as the critical components required for synapse stability and NK cell triggering. These data are incredibly valuable for our continued development of INKmune but, equally importantly, establishing the mechanism of action of INKmune as "increasing NK avidity" gives us a perfect tool and assay to measure potency of batches of INKmune, which is required by drug regulatory agencies" said Professor Lowdell, CSO of INmune Bio.

The z-Movi Cell Avidity Analyzer is a novel platform that measures the binding strength between target and immune cells, which is a key event in the mode of action of immune products. Furthermore, the z-Movi platform provides these measurements across a large population of cells, rapidly, with single-cell resolution. Cell avidity solutions have the potential to shorten the drug development cycle for adoptive cell therapies and other immune-therapies and reduce failure rates in clinical trials.

"We are excited to work together with INmune Bio, a pioneer in immunotherapy that harnesses the innate immunity of patients to combat solid and liquid cancers," said Dr. Andrea Candelli, CSO and co-founder of LUMICKS. "We strive to provide the benefits of fast, predictive, and reproducible cell avidity measurements to partners like INmune, in order to continue to advance science and accelerate the entry of cell-based therapies into clinical trials."

On July 22, 2021 Biogen Inc. (Nasdaq: BIIB) reported second quarter 2021 financial results (Press release, Biogen, JUL 22, 2021, View Source,%24448%20million%20and%20%242.99%2C%20respectively.&text=Second%20quarter%20Non%2DGAAP%20net,%24852%20million%20and%20%245.68%2C%20respectively. [SID1234585115]).

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"We were pleased with our operational performance in the second quarter," said Michel Vounatsos, Biogen’s Chief Executive Officer. "Biogen has the market-leading portfolio of therapies for MS, has launched the first approved and market-leading therapy for SMA, and now has the first approved therapy to address a defining pathology of Alzheimer’s disease. In addition, we recently reported positive data in depression and stroke, and we look forward to the expected Phase 3 data for tofersen, the first genetically-targeted potential therapy for ALS, for which we have begun offering individual compassionate use access." Second Quarter 2021 Financial Results

• Second quarter total revenue of $2,775 million decreased 25% versus the prior year at actual currency and decreased 26% at constant currency*. o Multiple sclerosis (MS) revenue, including royalties on sales of OCREVUS, of $1,786 million decreased 24% versus the prior year at both actual and constant currency. o SPINRAZA revenue of $500 million increased 1% versus the prior year at actual currency and decreased 3% at constant currency. o ADUHELM revenue was $2 million. o Biosimilars revenue of $202 million increased 18% versus the prior year at actual currency and increased 9% at constant currency. 2 o Other revenue of $99 million decreased 76% versus the prior year at both actual and constant currency, primarily due to approximately $330 million in revenue in the second quarter of 2020 related to the license of certain manufacturingrelated intellectual property to one of our corporate partners.

• Second quarter GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. were $448 million and $2.99, respectively.

• Second quarter Non-GAAP net income and diluted EPS attributable to Biogen Inc. were $852 million and $5.68, respectively. A reconciliation of GAAP to Non-GAAP financial measures included in this news release can be found in Table 4 at the end of this news release. * Percentage changes in revenue growth at constant currency are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. The current period’s foreign currency revenue values are converted into U.S. dollars using the average exchange rates from the prior period Beginning in the second quarter of 2021 material upfront payments and premiums paid on the acquisition of common stock associated with significant collaboration and licensing arrangements along with the related transaction costs incurred are no longer excluded from Non-GAAP R&D and SG&A expenses. Non-GAAP financial results for the second quarter of 2020 have been updated to reflect the $208 million payment related to the collaboration with Sangamo Therapeutics, Inc. along with the associated transaction costs and income tax effect. o Second quarter 2021 GAAP and Non-GAAP R&D expense includes a $30 million upfront payment related to a commercialization and license agreement with Bio-Thera Solutions, Ltd. (Bio-Thera) in addition to $20 million in upfront payments related to collaboration agreements with Capsigen Inc. (Capsigen) and Ginkgo Bioworks (Ginkgo).

• Second quarter 2021 GAAP amortization and impairment of acquired intangible assets was $604 million, including an impairment charge of approximately $350 million 3 related to BIIB111 (timrepigene emparvovec) in choroideremia and a $192 million impairment charge related to BIIB112 (cotoretigene toliparvovec) in X-linked retinitis pigmentosa, both of which were based on recent data readouts. These amounts are excluded from Non-GAAP financial results.

• Second quarter 2021 GAAP and Non-GAAP collaboration profit sharing reduced our net operating expenses by $15 million, which includes a reimbursement of $85 million from Eisai Co., Ltd. (Eisai) related to the commercialization of ADUHELM in the U.S.

• Second quarter 2021 GAAP other income was $96 million, primarily driven by unrealized gains on our strategic equity investments of $154 million. Second quarter 2021 Non-GAAP other expense was $58 million, primarily driven by interest expense.

• Second quarter 2021 effective GAAP and Non-GAAP tax rates were (70%) and 16%, respectively. The second quarter 2021 effective GAAP tax rate was impacted by a deferred tax benefit associated with the accelerated approval of ADUHELM by the U.S. Food and Drug Administration (FDA). We recorded a deferred tax asset of approximately $500 million related to Neurimmune SubOne AG’s (Neurimmune) tax basis in ADUHELM, with an equal and offsetting amount assigned to noncontrolling interest, resulting in zero net impact to net income attributable to Biogen Inc.

• Second quarter 2021 GAAP and Non-GAAP income attributable to noncontrolling interest were $577 million and $84 million, respectively, which includes a milestone payment of $100 million to Neurimmune related to the launch of ADUHELM in the U.S. GAAP income attributable to noncontrolling interest also includes the offset to a deferred tax benefit related to Neurimmune’s tax basis in ADUHELM of approximately $500 million. Financial Position

• As of June 30, 2021, Biogen had $7,269 million in total debt. Cash, cash equivalents, and marketable securities totaled $3,966 million. This resulted in net debt of $3,303 million.

• In the second quarter of 2021 Biogen repurchased approximately 1.6 million shares of the Company’s common stock for a total value of $450 million. As of June 30, 2021, there was $3,550 million remaining under the share repurchase program authorized in October 2020.

• For the second quarter of 2021 the Company’s weighted average diluted shares were 150 million.

• Second quarter 2021 cash from operations was $1,227 million. Capital expenditures were $72 million, and free cash flow, defined as cash flow from operations less capit

al expenditures, was $1,155 million.This financial guidance continues to assume modest ADUHELM revenue in 2021, ramping thereafter. This guidance also continues to assume erosion of TECFIDERA and RITUXAN in the U.S. Biogen expects the decreased revenue from these high margin products to reduce its gross margin percentage compared to 2020.

Non-GAAP R&D expense is expected to be between $2.45 billion and $2.55 billion, an increase from prior guidance primarily due to an expected $125 million upfront payment in the third quarter of 2021 associated with our recently announced collaboration with InnoCare Pharma Limited (InnoCare).

This payment was not included in our prior guidance. Non-GAAP SG&A expense is expected to be between $2.6 billion and $2.7 billion, consistent with our previous guidance. This guidance continues to reflect our expectation that both Non-GAAP R&D and Non-GAAP SG&A expenses will be higher in the second half of the year than they were in the first half due to collaborations, program readouts, and investments in ADUHELM.

We expect that we will utilize a portion of the remaining share repurchase authorization of $3,550 million throughout 2021. This guidance assumes that foreign exchange rates as of June 30, 2021, will remain in effect for the remainder of the year, net of hedging activities.