On May 12, 2022 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported financial results for the first quarter ended March 31, 2022 (Press release, Aduro Biotech, MAY 12, 2022, View Source [SID1234614474]).

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"During the first quarter of 2022, we made strong progress advancing our pipeline of clinical, research and discovery programs for rare, severe chronic kidney diseases. We continue to enroll patients in the phase 3 ALIGN and phase 2 AFFINITY trials for atrasentan as well as the phase 1/2 trial of BION-1301, and we are pleased to have recently initiated the phase 1 healthy volunteer trial of CHK-336, our first internally-discovered program for the treatment of primary and idiopathic hyperoxaluria," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "We look forward to the upcoming 59th ERA Congress being held May 19th – 22nd, where we will present clinical data from both our lead programs, atrasentan and BION-1301, in patients with IgA nephropathy (IgAN)."

Recent Accomplishments and Updates

Atrasentan

Atrasentan is a potent and selective endothelin A (ETA) receptor antagonist that has the potential to provide benefit in multiple chronic kidney diseases by reducing proteinuria and having direct anti-inflammatory and anti-fibrotic effects to preserve kidney function. The phase 3 ALIGN trial of atrasentan is currently enrolling patients with IgAN, and the phase 2 AFFINITY basket trial of atrasentan is currently enrolling patients with proteinuric glomerular diseases.

Enrollment of the phase 3 ALIGN trial of atrasentan continues to advance with the activation of new trial sites and expansion into additional countries. Chinook expects to report topline data from the six-month interim proteinuria endpoint analysis in 2023 to support an application for accelerated approval under Subpart H in the United States.

Chinook plans to present data from the IgAN patient cohort of the phase 2 AFFINITY trial in an oral presentation at the 59th ERA Congress on May 20, 2022, and provide a program update on atrasentan during an investor conference call and webcast at 4:15 pm EDT that day. Chinook has completed enrollment of the IgAN patient cohort of this trial, and continues to enroll the other three cohorts, including patients with focal segmental glomerulosclerosis (FSGS), Alport syndrome and diabetic kidney disease in combination with SGLT2 inhibitors.

Chinook will deliver a mini-oral presentation at the 59th ERA Congress on May 19, 2022 on preclinical mechanistic work describing atrasentan’s effect to block mesangial cell injury and the pathogenic transcriptional networks driving IgAN progression in a model system.

In March 2022, Chinook presented an overview of the phase 2 AFFINITY clinical trial at the 4th Annual Chronic Kidney Disease (CKD) Drug Development Summit.

In February 2022, Chinook delivered an encore trials-in-progress presentations on the phase 3 ALIGN and phase 2 AFFINITY clinical trials at the ISN World Congress of Nephrology 2022.

BION-1301

BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 1/2 development for patients with IgAN. BION-1301’s potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1) to prevent the formation of pathogenic immune complexes has been demonstrated preclinically as well as clinically in both healthy volunteers and patients with IgAN.

Chinook will present additional data from Cohort 1 of Part 3 in a mini-oral presentation at the 59th ERA Congress on May 19, 2022. After at least 24 weeks of treatment, all eight patients in Cohort 1 transitioned from IV dosing at 450 mg every two weeks to SC dosing at 600 mg every two weeks.

Enrollment of Cohort 2 of Part 3 of the ongoing phase 1/2 trial of BION-1301 is ongoing. Patients in Cohort 2 receive a SC dose of 600 mg of BION-1301 every two weeks. Data from Cohort 2 is expected in the second half of 2022.

Chinook will present a trials-in-progress mini-oral presentation at the 59th ERA Congress on May 19, 2022 on the ongoing phase 1/2 trial of BION-1301.

In March 2022, Chinook presented a detailed overview of the BION-1301 program at the 4th Annual CKD Drug Development Summit.

In February 2022, Chinook delivered encore presentations on data from Cohort 1 of Part 3 as well as a trials-in-progress of the ongoing phase 1/2 trial of BION-1301 at the ISN World Congress of Nephrology 2022.

CHK-336

CHK-336 is an oral small molecule lactate dehydrogenase A (LDHA) inhibitor with liver-targeted tissue distribution that Chinook is developing for the treatment of patients with primary hyperoxaluria (PH), secondary hyperoxaluria due to increased endogenous oxalate production and idiopathic stone formation.

In April 2022, Chinook initiated dosing in a phase 1 clinical trial evaluating CHK-336 in healthy volunteers. Data from this trial is expected in the first half of 2023.

Precision Medicine Research & Discovery

Chinook is focused on the discovery and development of novel precision medicines for rare, severe chronic kidney diseases (CKDs) with defined genetic or molecular drivers of disease initiation and progression, and efficient development paths. Chinook has multiple preclinical programs across the discovery, target validation, lead identification and lead optimization stages to generate future clinical pipeline candidates. Chinook is leveraging its ongoing strategic collaboration with Evotec to identify and validate novel targets and enable patient stratification strategies through access to the NURTuRE CKD Patient Biobank, which provides comprehensive PANOMICS characterization of thousands of CKD patients with prospective clinical follow-up and retained bio-samples of urine and blood for exploratory biomarker analysis.

Chinook will deliver an oral presentation at the 59th ERA Congress on May 20, 2022 on the approach used in collaboration with Evotec to leverage the NURTuRE CKD biobank to generate mechanistic disease understanding for patient-centric, integrated target and biomarker discovery that will enable the development of novel precision treatments for CKD patient subsets.

In March 2022, Chinook participated in a panel on the challenges and opportunities in drug development for rare kidney diseases at the 4th Annual CKD Drug Development Summit.

Corporate

In April 2022, Chinook announced an outreach initiative in collaboration with the IgA Nephropathy Foundation and Komodo Health, leveraging data and technology to drive awareness of IgAN and engage key medical providers at nephrology practices across the U.S., with the goal of ensuring patients have access to optimal support and treatment options earlier in their disease journey.

In March 2022, Chinook announced the appointment of Dr. Mahesh Krishnan, group vice president of research and development at DaVita Inc., to its Board of Directors.

In January 2022, Chinook announced the appointment of Dr. Charlotte Jones-Burton as senior vice president of product development and strategy.

First Quarter 2022 Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $330.0 million at March 31, 2022, compared to $355.1 million at December 31, 2021.

Revenue – Revenue for the quarter ended March 31, 2022 was $2.7 million compared to $0.4 million for the same period in 2021. The increase was primarily due to revenue recognized under Chinook’s license agreement with SanReno.

Expenses –

Research and development expenses for the quarter ended March 31, 2022 were $26.3 million compared to $25.7 million for the same period in 2021. The increase was primarily due to higher employee-related costs from increased staff to build out our clinical and development capabilities; increased spending for consulting and outside services; and an increase in facilities and other costs. These increases were partially offset by a decrease in licensing and contract research and manufacturing costs. The decrease resulted from an upfront fee of $3.3 million to Evotec International GmbH included in the quarter ended March 31, 2021 and lower costs from clinical trials initiated in 2021.

General and administrative expenses for the quarter ended March 31, 2022 were $7.9 million compared to $9.5 million for the same period in 2021. The decrease was primarily due to lower consulting and other professional services costs; lower employee-related costs; and a decrease in facilities and other costs. These decreases were partially offset by an increase in stock-based compensation expense resulting from new grants.

The change in fair value of contingent consideration and contingent value rights liabilities for the quarter ended March 31, 2022 was a benefit of $1.0 million compared to expense of $1.8 million for the same period in 2021. The decrease in these non-cash expenses primarily resulted from a change in estimate of the potential future proceeds derived from the Merck collaboration.

Other –

A $10.0 million development milestone under the Merck collaboration was earned in the fourth quarter of 2021 and received in the first quarter of 2022. We expect to pay this milestone, net of taxes and expenses, to the CVR holders in the second quarter of 2022.

Net Loss – Net loss for the first quarter of 2022 was $31.7 million, or $0.54 per basic share, compared to a net loss of $37.2 million, or $0.88 per share for the same period in 2021.

On May 12, 2022 IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the first quarter ended March 31, 2022 (Press release, IntelGenx, MAY 12, 2022, View Source [SID1234614531]). All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2022 First Quarter Financial Summary:

Revenue was $237,000, compared to $286,000 in the 2021 first quarter.
Net comprehensive loss was $3.0 million, compared to $2.3 million in Q1-2021.
Adjusted EBITDA loss was $2.1 million, compared to $1.7million in the 2021 first quarter.
Cash and short-term investments totaled $10.2 million as at March 31, 2022 compared to $2.0 million as at March 31, 2021.
First Quarter and Recent Developments:

Presented at the 2022 Bloom Burton & Co. Healthcare Investor Conference.
The Company’s wholly owned subsidiary, IntelGenx Corp., received a third term loan in the amount of $3.0 million pursuant to its amended and restated secured loan agreement with atai Life Sciences ("atai").
Resumed patient dosing in the ongoing Phase 2a ‘BUENA’ clinical trial in patients with mild to moderate Alzheimer’s Disease under a previously amended protocol using higher doses of Montelukast VersaFilm.
"We continued to advance our portfolio of innovative film products and product candidates this quarter, and were pleased to have achieved a significant milestone in that regard with the resumption of patient screening in our ongoing ‘BUENA’ Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate AD," commented Dr. Horst G. Zerbe, CEO of IntelGenx.

Financial Results:

Total revenues for the three-month period ended March 31, 2022 amounted to $237,000, a decrease of 17%, compared to $286,000 for the three-month period ended March 31, 2021. The change is mainly attributable to a decrease in product revenues of $160,000, partially offset by increases in Research and Development ("R&D") revenues of $99,000 and royalties of $12,000.

Operating costs and expenses were $2.6 million for the first quarter of 2022, versus $2.2 million for the corresponding three-month period of 2021. The increase for the three-month period ended March 31, 2022 is mainly attributable to increases of $327,000 in R&D expense, $155,000 in selling, general and administrative expenses, and $3,000 in depreciation of tangible assets, offset partially by a $151,000 decrease in manufacturing expenses.

For the first quarter of 2022, the Company had an operating loss of $2.3 million, compared to an operating loss of $1.9 million for the comparable period of 2021.

Net comprehensive loss for the three-month period ended March 31, 2022 was $3.0 million, or $0.02 per basic and diluted share, compared to net comprehensive loss of $2.3 million, or $0.02 per basic and diluted share, for the comparable period of 2021. The increase for the 2022 first quarter was primarily attributable to higher R&D expenses and a reduction in fair value of short-term investments.

As at March 31, 2022, the Company’s cash and short-term investments totalled $10.2 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these first quarter 2022 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0062 (Canada and the United States) and (973) 528-0011 (International), access code 546214. The call will also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On May 12, 2022 Palatin Technologies, Inc. ("Palatin" or the "Company") (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, reported that it has entered into a securities purchase agreement with institutional investors pursuant to which Palatin will issue and sell 8,100,000 shares of its Series B convertible redeemable preferred stock and 900,000 shares of its Series C convertible redeemable preferred stock to such investors (Press release, Palatin Technologies, MAY 12, 2022, View Source [SID1234614278]). Each share of Series B and Series C preferred stock has a purchase price of $1.67. Each share of Series B and Series C preferred stock is convertible into shares of Palatin’s common stock at an initial conversion price of $0.45 per share. The investors in the Series B and Series C preferred stock also received warrants to purchase up to 1,666,667 shares of common stock at an exercise price of $0.50 per share, expiring 48 months following issuance. Total gross proceeds from the offering, before deducting estimated offering expenses, is approximately $15 million.

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Shares of the Series B and Series C preferred stock are convertible, at the option of the holder, at the earlier of 90 days from closing of the issuances of the Series B and Series C preferred stock and any time following the Company’s receipt of stockholder approval for a reverse stock split (RSS) of the Company’s common stock and until the thirtieth (30th) calendar day following the RSS date, into 33,333,333 common shares, computed by dividing the aggregate stated value of the preferred stock of $15 million by the conversion price of $0.45. Alternatively, following approval for a RSS and before the thirtieth (30th) calendar day following the RSS date, the holders of Series B and Series C preferred stock shall have the right to elect to have all of the outstanding shares of Series B and Series C preferred stock redeemed by the Company for cash in an amount equal to the stated value of such shares or for debt in an aggregate principal amount equal to the stated value of such shares, and receive a redemption fee of $750,000, representing 5% of the aggregate stated value of the preferred shares.

Palatin expects to call a meeting of stockholders to seek approval of, among other things, an amendment to its certificate of incorporation to effect the RSS (the "Proposal"). Except as otherwise required by law, holders of the Series B and Series C preferred stock are entitled to vote only on the Proposal and any proposal to adjourn any meeting of stockholders at which the Proposal is submitted and will vote together with the holders of common stock and each other class or series of capital stock of the Company as a single class. The holders of Series B preferred stock are entitled to a number of votes equal to the number of shares of common stock into which the Series B preferred is convertible on the issuance date. The holders of the Series C preferred stock are entitled to a number of votes equal to 20,000 votes per share of common stock into which the Series C preferred is convertible. The holders of Series C preferred stock have agreed to vote the shares of Series C preferred stock with respect to the Proposal (or any proposal to adjourn the meeting of stockholders at which the Proposal is submitted) in the same proportion as the shares of common stock, Series A preferred stock, and Series B preferred stock that are voted on such proposals.

To the extent any shares of Series B or Series C preferred stock are converted to common shares or redeemed for debt, the Company will use such net proceeds from this offering for working capital and general corporate purposes.

Additional information regarding the securities described above and the terms of the offering will be included in a filing with the United States Securities and Exchange Commission ("SEC").

The Series B and Series C preferred stock and warrants and shares of common stock into which these preferred shares and warrants are convertible are being issued in reliance upon the exemption from the securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act") and/or Rule 506 of Regulation D as promulgated by SEC under the 1933 Act.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

On May 12, 2022 Upsher-Smith Laboratories, LLC (Upsher-Smith) reported that Taku Nakaoka has been appointed Chairman and Chief Executive Officer (CEO) of Upsher-Smith, effective May 13 (Press release, Upsher-Smith Laboratories, MAY 12, 2022, View Source [SID1234614323]). Additionally, Senior Vice President of Corporate Strategy, Rich Fisher, has been appointed President and Chief Operating Officer (COO) responsible for the day-to-day leadership of Upsher-Smith . Mr. Nakaoka succeeds Rusty Field, who previously served as President and CEO and recently departed the Company to pursue another opportunity.

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As Chairman and CEO, Mr. Nakaoka is responsible for the strategic direction, operating performance and growth of Upsher-Smith. Mr. Nakaoka also serves as Corporate Officer and Group Chief Officer of Corporate Strategy of Sawai Group Holdings Co., Ltd., Upsher-Smith’s parent company, and Corporate Officer and General Manager of Corporate Strategy at Sawai Pharmaceutical Co., Ltd. Prior to Sawai, he held several executive-level positions at Sumitomo Corporation.

"I am honored to assume this role as Chairman and CEO and look forward to working alongside the executive team to drive the strategic direction of the company, expand global partnerships and enhance programs critical to future growth," said Taku Nakaoka, Chairman and CEO of Upsher-Smith. "Rusty’s strong and determined leadership over the past eight years was integral to building a strong foundation for Upsher-Smith and Rich Fisher’s previous role as Senior Vice President of Corporate Strategy makes him well-positioned to successfully lead the company as President and COO."

On May 12, 2022 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the first quarter ended March 31, 2022 (Press release, 2seventy bio, MAY 12, 2022, View Source [SID1234614340]).

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"2seventy bio has started 2022 in a strong position, and we’ve already begun to execute on some key clinical milestones," said Nick Leschly, chief kairos officer. "This quarter, we enrolled the first patients in clinical studies of SC-DARIC33 and bbT369. We look forward to continuing to enroll patients in these studies and providing an update at the appropriate time. In addition, we continue to focus on other foundational elements of 2seventy bio: growth of ABECMA and a sound financial position. Despite a challenging external environment, I’m pleased with the steady progress on both fronts with continued demand for ABECMA as well securing additional capital in March that we anticipate will provide cash runway into 2025. We’re proud of the momentum we’ve established as a team at 2seventy bio because we know that every day matters as we focus on delivering more time to patients with cancer and their families."

COMMERCIAL PROGRESS
Bristol Myers Squibb reported total U.S. ABECMA (idecabtagene vicleucel; ide-cel) first quarter revenues of $56 million, consistent with our 2022 plan. 2seventy bio and Bristol Myers Squibb share equally in all profits and losses related to developing, manufacturing and commercializing ABECMA in the U.S. In 2022, 2seventy anticipates total U.S. ABECMA revenues of $250-$300 million and we are continuing to track to the high end of the range bolstered by continued high demand for a proven treatment and increasing manufacturing capacity.

Demand for ABECMA is expected to continue to fully utilize the expanding manufacturing capacity throughout 2022 and 2023.

RECENT HIGHLIGHTS

SC-DARIC33 FIRST PATIENT ENROLLED – Last quarter, the first patient with acute myeloid leukemia (AML) was enrolled in PLAT-08, a phase 1 study of SC-DARIC33 led by Seattle Children’s Therapeutics in relapsed or refractory pediatric and young adult AML. This is the first-in-human application of 2seventy bio’s proprietary DARIC T cell platform.
BBT369 FIRST PATIENT ENROLLED – Last quarter, the first patient with B cell non-Hodgkin lymphoma (B-NHL) was enrolled in CRC-403, a phase 1/2 study of bbT369 in patients with relapsed and/or refractory B-NHL. This study serves as a safety and proof-of-concept assessment of 2seventy bio’s proprietary megaTAL gene editing platform, dual-targeting strategies and split co-stimulation signaling technology.
bbT369 PRECLINICAL DATA AT AACR (Free AACR Whitepaper) – New preclinical data on bbT369 was presented in a poster session (poster #581) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans, LA on Sunday, April 10. The data presented at AACR (Free AACR Whitepaper) show the anti-lymphoma activity of bbT369 observed to date and suggest that, as intended in the design, bbT369 has the potential to overcome failure modes of anti-CD19 CAR therapies.
ASCO ABSTRACTS ACCEPTED– In April 2022, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) released the abstract titles for its 2022 Annual Meeting. 2seventy bio will present updates from its portfolio of oncology cell therapies at the meeting, including a correlative analysis, in partnership with Bristol Myers Squibb, defining patient profiles associated with manufacturing and clinical endpoints in patients treated with ide-cel, and a trial in progress poster on CRB-403, a phase 1/2 study on bbT369.
Poster Discussion [#8021]: Correlative analysis to define patient profiles associated with manufacturing and clinical endpoints in relapsed/refractory multiple myeloma (RRMM) patients treated with idecabtagene vicleucel (ide-cel; bb2121), an anti-BCMA CAR T cell therapy.
Presenting Author: Julie Rytlewski, PhD, Bristol Myers Squibb
Date/Time: Saturday, June 4, 2022, 5:30 PM – 7:00 PM ET
Poster [#TPS7580]: CRC-403: A phase 1/2 study of bbT369, a dual targeting CAR T-cell drug product with a gene edit, in relapsed and/or refractory B-cell non-Hodgkin lymphoma (NHL).
Presenting Author: Frederick L. Locke, MD, H. Lee Moffitt Cancer Center & Research Institute
Date/Time: Saturday, June 4, 2022, 9:00 AM – 12:00 PM ET
UPCOMING ANTICIPATED MILESTONES

ABECMA

Anticipated $250-300 million total U.S. commercial revenue in 2022; profits and losses shared with Bristol Myers Squibb
Increasing manufacturing capacity expected over 2022 and 2023
KarMMa-2 study in high-risk multiple myeloma proof-of-concept data in 2022
KarMMa-3 study in 3L+ registrational data in 2023 with potential FDA approval in 2023-2024
Pipeline

Initial assessment of feasibility of bbT369 drug product manufacturing and patient safety in 2H 2022
Initial assessment of feasibility of SC-DARIC33 drug product manufacturing and drug regulated anti-CD33 activity in 2H 2022
SELECT FIRST QUARTER 2022 FINANCIAL RESULTS

Bristol Myers Squibb reported total U.S. revenues of $56 million for ABECMA for the three months ended March 31, 2022. 2seventy bio and Bristol Myers Squibb share equally in all profits and losses related to development, manufacturing and commercializing ABECMA in the U.S. We reported share of collaboration loss of $5.4 million for the three months ended March 31, 2022, which includes our share of gross profit/loss less costs associated with the commercialization of ABECMA in the U.S. The collaboration reported a loss this quarter due to continued investment in manufacturing scale-up and commercialization.
Total revenues were $8.4 million for the three months ended March 31, 2022, compared to $11.9 million for the three months ended March 31, 2021. The decrease for the three-month period was primarily driven by a decrease in royalty and other revenue as a result of the termination of the Company’s license agreement with Novartis in March 2021.
Research and development expenses were $69.2 million for the three months ended March 31, 2022, compared to $77.6 million for the three months ended March 31, 2021. The decrease for the period was primarily driven by decreased collaboration research costs, which represent the Company’s share of research and development costs under the collaboration with Bristol Myers Squibb.
Selling, general and administrative expenses were $23.9 million for the three months ended March 31, 2022, compared to $24.6 million for the three months ended March 31, 2021. The slight decrease was primarily driven by a decrease in employee compensation expense. In 2021, the Company recorded higher stock-based compensation and bonus expense related to a retention plan that was enacted during the separation of 2seventy bio from bluebird bio. The retention plan was completed at the end of 2021.
Net loss was $85.7 million for the three months March 31, 2022, compared to $87.2 million for the three months ended March 31, 2021.
2seventy bio ended the first quarter of 2022 with cash, cash equivalents and marketable securities of $452.5 million, including net proceeds from our March 2021 private placement of $165.7 million, after deducting placement agent fees and other offering expenses payable by the Company.