On May 11, 2021 Insmed Incorporated (Nasdaq: INSM) reported that it priced a registered underwritten public offering of 10,000,000 shares of its common stock (the "Shares") at a price to the public of $25.00 per share before deducting underwriting discounts and commissions, and a registered underwritten public offering of $500 million aggregate principal amount of its 0.75% convertible senior notes due 2028 (the "Notes") (Press release, Insmed, MAY 11, 2021, View Source [SID1234579732]). A portion of the net proceeds from the offering of the Notes will be used to repurchase $225 million in aggregate principal amount of Insmed’s existing outstanding 1.75% Convertible Senior Notes due 2025 (the "2025 Notes"). The gross proceeds to Insmed from the offerings, before deducting underwriting discounts and commissions and other offering expenses payable by Insmed, are expected to be $250 million and $500 million, respectively. In addition, Insmed has granted the underwriters of the offering of Shares (the "Equity Offering") a 30-day option to purchase up to an additional 1,500,000 Shares and to the underwriters of the offering of the Notes (the "Notes Offering") a 30-day option, solely to cover over-allotments, to purchase up to an additional $75 million in aggregate principal amount of the Notes. All of the Shares and Notes to be sold in the offerings are to be sold by Insmed.

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The offerings are expected to close on or about May 13, 2021, subject to satisfaction of customary closing conditions. The closing of each offering is not contingent on the closing of the other offering.

The Notes will be senior unsecured obligations of Insmed and will rank senior in right of payment to any of Insmed’s future indebtedness that is expressly subordinated in right of payment to the Notes and will rank equally in right of payment with all of Insmed’s existing and future liabilities that are not so subordinated, including the existing 2025 Notes. The Notes will accrue interest payable semiannually in arrears on June 1 and December 1 of each year at the rate of 0.75% per year, beginning on December 1, 2021. The Notes will mature on June 1, 2028, unless earlier repurchased, redeemed or converted in accordance with their terms prior to such date. Prior to June 6, 2025, Insmed will not have the right to redeem the Notes. Subject to certain conditions, on or after June 6, 2025, Insmed may redeem for cash all or a part of the Notes. Prior to March 1, 2028, the Notes will be convertible at the option of holders of the Notes only upon satisfaction of certain conditions and during certain periods, and thereafter, will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. Upon conversion, holders of the Notes will receive shares of Insmed common stock, cash or a combination thereof, at Insmed’s election. The conversion rate for the Notes will initially be 30.7692 shares of Insmed common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $32.50 per share, and is subject to adjustment under the terms of the Notes. Insmed may be obligated to increase the conversion rate for any conversion that occurs in connection with certain corporate events or a redemption of the Notes by Insmed. The initial conversion price represents a premium of approximately 30% over the public offering price per share of the Shares in the Equity Offering.

Concurrently with the offerings, Insmed plans to enter into separate and privately negotiated repurchase transactions with certain holders of a portion of the 2025 Notes. In these transactions, Insmed plans to repurchase 2025 Notes with an aggregate principal amount of $225 million for an aggregate repurchase price of approximately $237 million plus accrued interest, using a portion of the net proceeds from the Notes Offering. Insmed intends to use the remaining net proceeds from the Notes Offering and the net proceeds from the Equity Offering to fund activities related to the commercialization and development of ARIKAYCE, further research and development of brensocatib, TPIP or any of its product candidates, and for other general corporate purposes, including business expansion activities.

J.P. Morgan Securities LLC and SVB Leerink LLC are acting as book-running managers for the offerings. Morgan Stanley & Co. LLC is also acting as a book-running manager for the offerings. Credit Suisse Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated are acting as co-lead managers for the Equity Offering. Cantor Fitzgerald & Co. and H.C. Wainwright & Co., LLC are acting as co-managers for the Equity Offering.

The Equity Offering and the Notes Offering are being made pursuant to Insmed’s shelf registration statement on Form S-3 (File No. 333-238560) including the base prospectus contained therein, a preliminary prospectus supplement related to the Equity Offering (together with such base prospectus, the "Equity Prospectus") and a preliminary prospectus supplement related to the Notes Offering (together with such base prospectus, the "Notes Prospectus"), all of which Insmed filed with the Securities and Exchange Commission ("SEC"). Before investing in the Shares or the Notes, investors should read the Equity Prospectus and the Notes Prospectus, respectively, in each case, including the documents incorporated by reference therein, and any free writing prospectus related to the Equity Offering and the Notes Offering, as the case may be. These documents may be freely obtained by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies may be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105 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 shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On May 11, 2021 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, reported its financial results for the first quarter ended March 31, 2021 and recent business highlights(Press release, Achilles Therapeutics, MAY 11, 2021, View Source [SID1234584048]).

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"Achilles made significant progress in the first quarter of 2021. We reported the first clinical data from our ongoing CHIRON and THETIS trials evaluating our precision TIL cNeT therapy in patients with non-small cell lung cancer and melanoma, respectively, and priced our successful US initial public offering on Nasdaq, which closed just after quarter-end," said Dr Iraj Ali, Chief Executive Officer of Achilles. "We continue to enroll and dose patients and have opened our first clinical sites in the US and EU. This year, we expect to report interim data from a total of ten patients that have received cNeT monotherapy across the CHIRON and THETIS trials and will also begin enrolling patients to receive higher dose cNeT. In addition, we will open Cohort B in the THETIS study to evaluate the addition of a PD-1 inhibitor to our cNeT therapy."

Business Highlights

Received a recommendation from the Independent Data Safety Monitoring Committee to continue the ongoing Phase I/IIa CHIRON and THETIS trials as planned

Announced initial clinical data from the first six patients dosed with the Company’s cNeT therapy showing encouraging evidence of cNeT engraftment, an overall tolerability profile similar to that of standard TIL products, stable disease in four out of the six patients, and one patient with tumor lesion reduction

Presented data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting detailing the Company’s comprehensive translational research program and insights into the in vivo dynamics of cNeT post-dosing, and the potential to develop a potency-based release assay

Strengthened the Board of Directors and Scientific Advisory Board with the additions of Julie O’Neill and Markwin Velders, Ph.D., respectively, and continued to build the team in the UK & US, including key appointments across manufacturing, supply chain and clinical operations, bio-processing and intellectual property

Received a Horizon 2020 grant as part of the Neoantigen Consortium, with the aim of developing a tool to predict neoantigen immunogenicity.

Financial Highlights

IPO: Priced an initial public offering of 9,750,000 ADRs at a public offering price of $18.00 per share for gross proceeds of $175.5 million. The IPO closed on April 6, 2021, after the quarter end.

Cash and cash equivalents: Cash and cash equivalents were $159.3 million as of March 31, 2021 as compared to $177.8 million as of December 31, 2020, not including $160.6 million in net proceeds from the IPO which closed on April 6, 2021. The Company anticipates that its existing cash and cash equivalents plus the IPO proceeds are sufficient to fund its planned operations into the second half of 2023, including full funding of the ongoing Phase I/IIa CHIRON and THETIS clinical trials.

Operating Expenses: Operating Expenses were $13.7 million for the quarter ended March 31, 2021, which included $8.9 million in Research & Development, and General and Administrative expenses of $4.8 million.

Net loss: Net loss attributable to ordinary shareholders was $13.8 million for the quarter ended March 31, 2021 and the basic and diluted net loss per ordinary share was $8.38 for the quarter ended March 31, 2021.

Upcoming Events

Iraj Ali, Chief Executive Officer, will participate in a fireside chat at the BofA Securities 2021 Virtual Healthcare Conference at on Thursday, May 13, 2021, at 9:30 a.m. ET / 2:30 p.m. BST.

A poster detailing abstract TPS9138 entitled, An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Clonal Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON), will be presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting taking place virtually from June 4-9, 2021. Full abstracts will be released on May 19, 2021 at ASCO (Free ASCO Whitepaper).org.

On May 11, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported its revenue and cash position for the three-month period ending March 31, 2021.

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"This quarter, we have continued to execute against our strategy, successfully progressing the lacutamab TELLOMAK trial in the mycosis fungoides cohort while also advancing our first NK cell engager with our partner, Sanofi," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "As we continue to advance our business, we look forward to delivering additional data read-outs from these programs this year, as well as leveraging our strong R&D competencies to lead the next wave of scientific innovation at Innate."

Pipeline highlights:

Lacutamab (IPH4102, anti-KIR3DL2 antibody):

In February 2021, the Company announced lacutamab showed a positive early signal in the KIR3DL2-expressing mycosis fungoides cohort (‘cohort 2’) of the TELLOMAK clinical trial. This cohort reached the pre-determined number of responses needed to advance to stage 2 earlier than anticipated. The Company plans to present this preliminary data as an oral presentation at the 16th International Conference on Malignant Lymphoma, Lugano (16-ICML) being held virtually between June 18-22, 2021.
The Company expects to initiate its Phase 1b trial evaluating lacutamab as a monotherapy in KIR3DL2-expressing patients with relapsed/refractory peripheral t-cell lymphoma (PTCL) by mid-2021. In addition, the Lymphoma Study Association (LYSA) will initiate an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in KIR3DL2-expressing relapsed/refractory PTCL patients in the second half of 2021.
IPH6101 (NKp46-based NK cell engager), partnered with Sanofi:

Progress was made in the NKCE collaboration with Sanofi, resulting in the decision announced in January 2021 that Sanofi will transition IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. IPH6101 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multi-specific antibody format (Gauthier et al. Cell 2019). The decision triggered a €7 million milestone payment from Sanofi to Innate.
In January 2021, a GLP-tox study was initiated for the IPH6101/SAR443579 program.
The Company will share an update on its NKCE platform at the Federation of Clinical Immunology Societies (FOCIS) meeting being held virtually between June 8-11, 2021.

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

The Company expects to publish data this year from the Phase 2 expansion cohort (‘cohort 3’), exploring the combination of monalizumab, cetuximab and durvalumab in first-line IO naïve patients with R/M SCCHN.

Avdoralimab in COVID-19 (anti-C5aR1 antibody):

The investigator-sponsored Phase 2 clinical trial, FORCE (FOR COVID-19 Elimination), has completed enrollment and is ongoing for patient follow-up and data analysis. More information on this study can be found at clinical trials.gov.

Financial Results:

Cash, cash equivalents and financial assets of the Company amounted to €181.7 million as of March 31, 2021. At the same date, financial liabilities amounted to €18.5 million.

During the first quarter of the year 2021, a €7.0m milestone payment was received from Sanofi in February 2021. This milestone followed the decision taken by Sanofi to advance IPH6101/SAR443579 into investigational new drug (IND)-enabling studies.

Revenues for the first three months of 2021 amounted to €4.5 million (€19.3 million for the same period in 2020). For the three-month period, ended March 31, 2021, revenue from collaboration and licensing agreements mainly results from the spreading of the payments received under our agreements with AstraZeneca and Sanofi. (Press release, Innate Pharma, MAY 11, 2021, View Source [SID1234579639])

On May 11, 2021 Applied Therapeutics, Inc. (Nasdaq: APLT) ("Applied Therapeutics" or the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the first quarter ended March 31, 2021 (Press release, Applied Therapeutics, MAY 11, 2021, View Source [SID1234579683]).

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"In the first quarter we continued to progress our late stage programs towards commercialization in Galactosemia and Diabetic Cardiomyopathy, while advancing our additional rare disease programs in SORD and PMM2-CDG," said Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. "We are looking forward to our planned NDA submission in Galactosemia in the third quarter of this year, and continue to focus on our primary objective – bringing drugs to patients in desperate need of treatment."

Recent Highlights

Initiated Phase 2 Study of AT-007 in Patients with SORD Deficiency. The Phase 2 pilot study of AT-007 in patients with Sorbitol Dehydrogenase Deficiency (SORD Deficiency), a progressive, debilitating hereditary neuropathy that affects peripheral nerves and motor neurons, has been initiated. Preclinical findings demonstrate that AT-007 has the potential to be the first disease-modifying therapy for SORD, targeting the underlying cause of disease.
Presented Data on Galactosemia Disease Progression at the 2021 Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics. In April 2021, the Company presented data featuring a cross-sectional analysis of nineteen pediatric patients with Classic Galactosemia, providing meaningful insight on the progressive worsening of the central nervous system phenotype with age.
Hosted Virtual Rare Disease Forum. In March 2021, the Company hosted a virtual forum highlighting its AT-007 development programs in Galactosemia, SORD Deficiency, and PMM2-CDG. A replay of the presentation, which featured several rare disease key opinion leaders, is available at View Source
Announced Restart of Pediatric Galactosemia Study. In February 2021, the Company announced that the FDA lifted the clinical hold on the AT-007 ACTION-Galactosemia Kids pediatric clinical study, and the study resumed immediately. Applied Therapeutics worked closely with FDA to modify the trial, with the shared goal of ensuring that all patients have the opportunity to receive clinical benefit, and remains on target to submit an NDA no later than Q3 2021.

Closed Approximately $75 million Public Offering. In February 2021, the Company completed an underwritten public offering of 3,450,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 450,000 additional shares of common stock at a price of $23.00 per share, resulting in aggregate net proceeds of approximately $74.4 million.
Financial Results

Cash and cash equivalents and short-term investments totaled $148.1 million as of March 31, 2021, compared with $96.8 million at December 31, 2020.

Research and development expenses for the three months ended March 31, 2021 were $14.4 million, compared to $7.3 million for the three months ended March 31, 2020. The increase of $7.2 million was primarily related to an increase in clinical and pre-clinical expense of $1.3 million, related to the progression of the AT-007 ACTION-Galactosemia adult extension study, the AT-007 ACTION-Galactosemia Kids pediatric registrational study and the AT-001 Phase 3 ARISE-HF clinical study; an increase in drug manufacturing and formulation costs of $5.2 million related to the progression of the manufacturing campaigns and the completion and release of AT-001 and AT-007 drug product batches; an increase in personnel expenses of $0.3 million due to the increase in headcount in support of our clinical program pipeline; an increase in stock-based compensation of $0.2 million due to new stock option and restricted stock unit grants; and an increase in regulatory and other expenses of $0.2 million relating to an increase in clinical consulting fees during the three months ended March 31, 2021.

General and administrative expenses were $9.8 million for the three months ended March 31, 2021, compared to $5.2 million for the three months ended March 31, 2020. The increase of approximately $4.6 million was primarily related to an increase of $1.9 million related to the establishment of a commercial department; an increase in stock-based compensation of $1.5 million and increase in personnel expenses of $0.9 million related to an increase in headcount; an increase of $0.2 million related to increased insurance costs; an increase of $0.4 million in other expenses relating to increased costs of rent and other office expenses; and a $0.4 million decrease in legal and professional fees due to lower external legal fees.
Net loss for the first quarter of 2021 was $24.2 million, or $1.00 per basic and diluted common share, compared to a net loss of $12.4 million, or $0.59 per basic and diluted common share, for the first quarter 2020.

On May 11, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the 2021 RBC Capital Markets Global Healthcare Conference on Tuesday, May 18, 2021 at 4:15 pm (ET) (Press release, Mannkind, MAY 11, 2021, View Source [SID1234579699]). Interested parties can access a link to the webcast from the Events & Presentations section of the Company’s website at View Source The webcast replay will remain available for 14 days following the live presentation.

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