On May 2, 2024 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported its financial results for the first quarter ended March 31, 2024, and provided an update on the Company’s operations (Press release, BridgeBio, MAY 2, 2024, View Source [SID1234642580]).

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"In addition to the important scientific work we have done to advance our patient mission this quarter, we have also taken a first step towards streamlining our firm and thereby unlocking value for patients and investors alike," said Neil Kumar, Ph.D., founder and CEO of BridgeBio. "We believe the launch of BBOT better aligns investors with an opportunity that was being hidden in our pipeline, and our partnership with these new investors enables us to prosecute these oncology programs more quickly and with higher fidelity. In tandem with our progress in corporate simplification and balance sheet strengthening, we continue to prepare for what we believe will be a world class launch this year in ATTR-CM and we continue to enroll our achondroplasia, ADH1 and LGMD2I/R9 clinical trials, all of which are expected to complete enrollment this year."

BridgeBio’s late stage programs:

Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM):

The EMA accepted the Company’s MAA for acoramidis for review, with an expected approval in 2025. This is in addition to the Prescription Drug User Fee Act (PDUFA) date of November 29, 2024 set by the U.S. FDA for the Company’s NDA for acoramidis for the treatment of ATTR-CM.

In March 2024, the Company entered into a licensing agreement granting Bayer exclusive rights to commercialize acoramidis for ATTR-CM in Europe; in exchange, BridgeBio is entitled to receive among other consideration:

Tiered royalties beginning in the low-thirties percent, and

Up to $310 million in upfront and near-term milestone payments, as well as additional sales milestones.

The Company presented cardiac magnetic resonance imaging evidence from an exploratory substudy where treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression. This evidence is consistent with clinical improvement observed in the Company’s ATTRibute-CM Phase 3 study of acoramidis in patients with ATTR-CM.

Additional detailed results of the Company’s ATTRibute-CM study are planned for presentation at 2024 medical meetings, including four abstracts accepted for presentation at the European Society of Cardiology Heart Failure conference in May 2024, and eleven abstracts accepted for presentation at the International Symposium on Amyloidosis in May 2024.

Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:

The PROPEL 3 global Phase 3 registrational study of infigratinib in achondroplasia continues to enroll; study completion continues to be anticipated for 2025.

The Company anticipates initiating its clinical program for hypochondroplasia in 2024, as part of its commitment to exploring the potential of infigratinib on the wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasias.

BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):

The Company believes there is potential to pursue Accelerated Approval for BBP-418 based on recent interactions with the FDA on the use of glycosylated αDG levels as a surrogate endpoint.

FORTIFY, the global Phase 3 registrational trial of BBP-418 in LGMD2I/R9, continues to enroll in the U.S., Europe and Australia. Full enrollment of the interim analysis population is expected in 2024.

Encaleret – Calcium-sensing receptor (CaSR) inhibitor for autosomal dominant hypocalcemia type 1 (ADH1):

CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, continues to enroll; the Company anticipates sharing topline data from CALIBRATE in 2025.
Recent Corporate Updates:

The Company announced the launch of BridgeBio Oncology Therapeutics (BBOT) with a $200 million private financing to accelerate the development of its novel precision oncology pipeline.
The $200 million financing was led by Cormorant Asset Management and co-led by Omega Funds, with participation from affiliates of Deerfield Management, GV (Google Ventures), EcoR1 Capital, Wellington Management, Enavate Sciences, Surveyor Capital (a Citadel company), Aisling Capital, Casdin Capital, and Longwood Fund.
BBOT will be led by Eli Wallace, Ph.D. as CEO and Pedro Beltran, Ph.D. as CSO; the Board of Directors for BBOT will be chaired by Frank McCormick, Ph.D., David A. Wood Distinguished Professor of Tumor Biology and Cancer Research at UCSF and advisor to the National Cancer Institute’s RAS Initiative at Frederick National Laboratory for Cancer Research. Raymond Kelleher, M.D., Ph.D., Managing Director Cormorant Asset Management, Michelle Doig, Partner, Omega Funds, and Neil Kumar, Ph.D., CEO of BridgeBio will serve as directors.
First Quarter 2024 Financial Results:

Cash, Cash Equivalents, Marketable Securities and Short-term Restricted Cash

Cash, cash equivalents, marketable securities and short-term restricted cash, totaled $519.8 million as of March 31, 2024, compared to $392.6 million of cash, cash equivalents and short-term restricted cash as of December 31, 2023. The $127.2 million net increase in cash, cash equivalents, marketable securities and short-term restricted cash was primarily attributable to net proceeds received from the term loan under the credit facility with Blue Owl of $437.7 million, net proceeds received of $315.3 million from various equity financings, proceeds from the sale of investments in equity securities of $63.2 million, and special cash dividends received from investments in equity securities of $25.7 million. These were primarily offset by refinancing of the Company’s previous senior secured credit and inclusive of prepayment fees and exit-related costs in aggregate of $473.4 million, net cash used in operating activities of $219.5 million and purchases of equity securities of $20.3 million during the three months ended March 31, 2024.

Revenue

Revenue for the three months ended March 31, 2024, were $211.1 million, as compared to $1.8 million for the same period in the prior year. The $209.3 million net increase for the three months ended March 31, 2024, compared to the same period in the prior year, was primarily due to the recognition of non-refundable upfront payments under the Bayer and the Kyowa Kirin exclusive license agreements. The remaining license and services revenue was recognized in connection with the Navire-BMS License Agreement, which was entered into in May 2022 and for which BMS provided notice of termination in March 2024 with a termination effective in June 2024.

Operating Costs and Expenses

Operating costs and expenses for the three months ended March 31, 2024 were $210.8 million compared to $128.0 million for the same period in the prior year.

The overall increase of $82.8 million in operating costs and expenses for the three months ended March 31, 2024, compared to the same period in the prior year, was primarily due to an increase of $48.1 million in research and development and other expenses (R&D) to advance the Company’s pipeline of development programs, and an increase of $34.7 million in selling, general and administrative (SG&A) expenses mainly to support commercialization readiness efforts. Operating costs and expenses for the three months ended March 31, 2024, include $22.5 million of nonrecurring deal-related costs for transactions that were closed during the period.

Restructuring, impairment and related charges for the three months ended March 31, 2024 amounted to $3.4 million. These charges primarily consisted of impairments and write-offs of long-lived assets, severance and employee-related costs, and exit and other related costs. Restructuring, impairment and related charges for the same period in the prior year was $3.4 million. These charges primarily consisted of winding down, exit costs, and severance and employee-related costs.

Stock-based compensation expenses included in operating costs and expenses for the three months ended March 31, 2024 were $28.9 million, of which $12.8 million is included in R&D expenses, and $16.1 million is included in SG&A expenses. Stock-based compensation expenses included in operating costs and expenses for the same period in the prior year were $23.5 million, of which $11.8 million is included in R&D expenses, and $11.7 million is included in SG&A expenses.

"With our recent equity financing activities, our licensing deal with Bayer for European commercial rights to acoramidis, our royalty funding agreement for $500 million upon FDA approval of acoramidis, and now the private financing of BBOT to advance our oncology pipeline into the clinic, we are in a strong financial position to launch acoramidis in the U.S. at the end of this year and deliver three Phase 3 readouts in 2025," said Brian Stephenson, Ph.D., CFA, Chief Financial Officer of BridgeBio.

On May 2, 2024 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported the completion of a $200M private financing of its former subsidiary, TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (BBOT), to accelerate the development of its oncology portfolio (Press release, BridgeBio, MAY 2, 2024, View Source [SID1234642579]). The oversubscribed financing was led by Cormorant Asset Management and co-led by Omega Funds with participation from affiliates of Deerfield Management, GV (Google Ventures), EcoR1 Capital, Wellington Management, Enavate Sciences, Surveyor Capital (a Citadel company), Aisling Capital, Casdin Capital, and Longwood Fund.

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BBOT will be advancing three initial programs:

BBO-8520, a direct inhibitor of KRASG12C that binds to both the ON and OFF states of the protein; BBOT is currently enrolling patients in the ONKORAS-101 trial for patients with KRASG12C mutant non-small cell lung cancer
BBO-10203, a PI3Kα:RAS breaker that blocks the specific interaction between RAS and PI3Ka to inhibit PI3Kα / AKT effector signaling in tumors while bypassing glucose metabolic signaling to avoid hyperglycemia; BBOT expects to file an Investigational New Drug application (IND) for BBO-10203 in Q2 2024 and, subject to clearance of the IND, will begin enrolling patients later this year
BBO-11818, a pan-KRAS inhibitor that targets both the ON and OFF states of KRASG12X for which BBOT expects to file an IND in early 2025
In addition to these assets, BBOT will continue to undertake a robust discovery-stage research program focused on targeting additional oncogenic drivers within the RAS and PI3K pathways.

BridgeBio Oncology Therapeutics will be led by Eli Wallace, PhD, as CEO and Pedro Beltran, PhD, as CSO. "We are excited to progress our portfolio of novel small molecules to treat patients suffering from RAS pathway malignancies. In conjunction with BridgeBio and an amazing suite of investors, we look forward to seeing all three of our programs progress into the clinic over the next 12 months," said Dr. Wallace.

The Board of Directors of BBOT will be chaired by Frank McCormick, PhD, David A. Wood Distinguished Professor of Tumor Biology and Cancer Research at UCSF and advisor to the National Cancer Institute’s RAS Initiative at Frederick National Laboratory for Cancer Research. Raymond Kelleher, MD, PhD, Managing Director, Cormorant Asset Management, Michelle Doig, Partner, Omega Funds, and Neil Kumar, PhD, CEO of BridgeBio, will serve as directors.

"I’m thrilled to partner with BridgeBio and this stellar investor syndicate to advance BBOT’s unique portfolio of precision oncology assets targeting RAS-driven cancers," said lead investor Raymond Kelleher, MD, PhD, of Cormorant Asset Management. "BBOT’s innovative chemical biology approaches to inhibit a wide spectrum of KRAS mutations in both the "on" and "off" states, as well as bypass mechanisms exploiting PI3K signaling, promise to transform the treatment of this important class of cancers."

"We are very excited about BBOT’s pipeline of potential first-in-class assets and to join a team of world class experts in RAS-driven malignancies, who we believe are positioned to have significant positive impact on cancer patients and build stakeholder value," added Michelle Doig from Omega Funds.

On May 2, 2024 Blueprint Medicines Corporation (Nasdaq: BPMC) reported its financial results, provided a business update for the first quarter ended March 31, 2024, and provided updated financial guidance (Press release, Blueprint Medicines, MAY 2, 2024, View Source [SID1234642578]).

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"We delivered another very strong quarter in our launch of AYVAKIT in indolent systemic mastocytosis (ISM) and have entered 2024 in a position of strength with great momentum across all aspects of our business. The first few quarters of a launch are critical in defining the sales trajectory for a product, and our revenue to-date positions us squarely on the path to achieve more than $2 billion in peak sales for AYVAKIT in systemic mastocytosis," said Kate Haviland, Chief Executive Officer of Blueprint Medicines. "Importantly, our growing revenue also enables us to invest in additional, compelling opportunities across our pipeline, where we can drive longer-term growth. This includes advancing our portfolio focused in allergy and inflammation as we move BLU-808 into the clinic in the second half of this year. I am proud of our team’s strong operational execution against our core value drivers, which enables Blueprint to realize the harmony between our mission of bringing new, innovative medicines to patients and building a robust and thriving business that will create substantial value for our shareholders."

First Quarter 2024 Highlights and Recent Progress

Mast cell disorders

·

Achieved AYVAKIT net product revenues of $92.5 million for first quarter of 2024, representing more than 135 percent growth year-over-year.

·

Presented long-term data from the PIONEER trial of AYVAKIT in ISM, demonstrating durable symptom impact and a well-tolerated safety profile, supporting long-term treatment and consistent with real-world experience observed in the commercial setting. Read the presentation here.

·

Presented preclinical data for BLU-808, a highly selective and potent investigational oral wild-type KIT inhibitor with best-in-class potential, for chronic urticaria and other mast cell disorders. BLU-808 treatment led to dose-dependent inhibition and depletion of mast cells in multiple in vivo studies, and also improved lung function in an ovalbumin-induced asthma model. Based on these data, Blueprint is on track to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for BLU-808 in the second quarter of 2024 to enable the initiation of a Phase 1 study in healthy volunteers. Read the presentation here.

·

Highlighted Blueprint’s strategy to leverage the company’s proven expertise in developing mast cell-targeted therapies to address large medical needs in allergy and inflammation. The company plans to host additional educational webcasts highlighting the evolving science around Blueprint’s portfolio strategy in the future. Watch the replay here.

HR+/HER2- breast cancer

·

Advanced the development of BLU-222, an oral, potent, and selective CDK2 inhibitor in combination with ribociclib and fulvestrant in patients with HR+/HER2- breast cancer, with plans to present the first positive combination safety data with signal of early clinical activity for a CDK2 inhibitor in combination with an approved CDK4/6 inhibitor at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Corporate

·

Announced that Rigel Pharmaceuticals, Inc. is purchasing the U.S. rights to research, develop, manufacture, and commercialize GAVRETO (pralsetinib), which allows continuity of patient access to GAVRETO in the U.S.

·

Published third annual Sustainability Report, highlighting Blueprint’s 2023 progress on environmental, social, and governance (ESG) initiatives and strategy and reflecting the results of a materiality assessment to focus our strategy on the most important ESG topics for the company and shareholders. Read the report here.

2024 Financial Guidance

Blueprint Medicines now anticipates approximately $390 million to $410 million in global AYVAKIT net product revenues for all approved indications in 2024, an increase from the previous range of $360 million to $390 million. This updated guidance reflects continued execution in the global launch for ISM, as well as a stronger than anticipated first quarter. The company continues to expect that full-year operating expenses and cash burn will decline in 2024 as compared to 2023, and that its existing cash, cash equivalents and investments, together with anticipated future product revenues, will enable the company to maintain a durable capital position to achieve a self-sustainable financial profile.

Key Upcoming Milestones

The company plans to achieve the following remaining milestones in the first half of 2024:

Mast cell disorders

·

Submit an IND to FDA for BLU-808 in the second quarter of 2024 to enable the initiation of a Phase 1 study in healthy volunteers.

HR+/HER2- breast cancer

·

Present data for BLU-222 in combination with ribociclib and fulvestrant for HR+/HER2- breast cancer at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.

·

Continue ongoing strategic business development discussions.

First Quarter 2024 Results

·

Revenues: Revenues were $96.1 million for the first quarter of 2024, including $92.5 million of net product revenues from sales of AYVAKIT/AYVAKYT and $3.6 million in collaboration revenues. Blueprint Medicines recorded revenues of $63.3 million in the first quarter of 2023, including $39.1 million of net product revenues from sales of AYVAKIT/AYVAKIT and $24.2 million in collaboration revenues.

·

Cost of Sales: Cost of sales was $3.2 million for the first quarter of 2024, as compared to $3.2 million for the first quarter of 2023. The relatively flat cost of sales was primarily attributed to the increased sales of lower cost dosages of AYVAKIT/AYVAKIT.

·

R&D Expenses: Research and development expenses were $88.2 million for the first quarter of 2024, as compared to $112.1 million for the first quarter of 2023. This decrease was primarily due to operational efficiency across our portfolio as we execute across our top priority programs and the timing of manufacturing of clinical trial materials. Research and development expenses included $10.9 million in stock-based compensation expenses for the first quarter of 2024.

·

SG&A Expenses: Selling, general and administrative expenses were $83.6 million for the first quarter of 2024, as compared to $71.0 million for the first quarter of 2023. This increase was primarily due to an increase in activities related to the commercialization of AYVAKIT/AYVAKYT. Selling, general, and administrative expenses included $13.4 million in stock-based compensation expenses for the first quarter of 2024.

·

Net Income (Loss): Net income was $89.1 million for the first quarter of 2024, as compared to a net loss of $129.6 million for the first quarter of 2023. The net income was primarily driven by a one-time non-cash debt extinguishment gain of $173.7 million recorded in connection with the Royalty Pharma termination agreement in the first quarter of 2024.

·

Cash Position: As of March 31, 2024, cash, cash equivalents and investments were $735.6 million, as compared to $767.2 million as of December 31, 2023. Blueprint Medicine’s cash and investments provide a durable capital position which enables the company to reach a self-sustainable profile.

Conference Call Information

Blueprint Medicines will host a live conference call and webcast at 8:00 a.m. ET today to discuss first quarter 2024 financial results and recent business activities. The conference call may be accessed by dialing 833-470-1428 (domestic) or 404-975-4839 (international), and referring to conference ID 186292. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

Upcoming Investor Conferences

Blueprint Medicines will participate in two upcoming investor conferences:

·

Citizens JMP Life Sciences Conference on Monday, May 13, 2024 at 10:00 am ET.

·

Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024 at 10:40 am ET.

A live webcast of the fireside discussions will be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source A replay of the webcasts will be archived on the Blueprint Medicines website for 30 days following the events.

On May 2, 2024 Biomea Fusion, Inc. ("Biomea" or "the Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported first quarter 2024 financial results and corporate highlights (Press release, Biomea Fusion, MAY 2, 2024, View Source [SID1234642577]).

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"Over the last two months we have seen a significant increase in the rate of enrollment for the expansion phase cohorts of our Phase 1/2 study, COVALENT-111, investigating BMF-219 in patients with type 2 diabetes. There is currently a waitlist for the fourth cohort which we expect will open for enrollment in the second half of this year. We have also seen a significant increase in the rate of enrollment of our Phase 2 study, COVALENT-112, in patients with type 1 diabetes following the press release which provided an early look at the first two patients dosed with BMF-219. Here we highlighted the first two patients dosed with BMF-219 demonstrated an increase in C-peptide Index (Amount of C-peptide secreted per unit of glucose) during the early stages of treatment. This is truly an exciting and validating update on our progress in type 1 diabetes. Patients with type 2 diabetes have lost about 50% of their pool of beta cells while patients with type 1 diabetes have lost at least 90% of their beta-cell pool at diagnosis and are therefore not able to produce sufficient insulin to address the glucose levels in their blood. Currently approved treatments for diabetes are mostly chronic treatments helping patients to reduce the blood glucose while the mass and function of the beta cells continues to decline. We have now demonstrated in multiple preclinical experiments that BMF-219 has the potential to address diabetes at the root cause level by improving the function and mass of beta cells. The data we reported from the escalation portion of our clinical study COVALENT-111 in the first quarter of 2024 demonstrated for the first time how an agent can achieve durable glycemic control while patients are off therapy, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes," stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. "In 2024, we expect to continue to advance our clinical programs with BMF-219 in diabetes and plan to report multiple data readouts throughout the remainder of the year, including topline Week 26 data of over 200 patients from our Phase 1/2 study, COVALENT-111, in type 2 diabetes, and topline Week 26 data from approximately 40 patients enrolled in the open label portion of our Phase 2 study, COVALENT-112, in type 1 diabetes patients. Our goal is to deliver a short-term, non-chronic treatment that will reconstitute insulin-producing beta cells, allowing the patients’ own bodies to normalize blood sugar levels."

DIABETES

COVALENT-111 (BMF-219 for Type 2 Diabetes)

Reported positive data from the escalation portion of Phase 2 study (COVALENT-111) in type 2 diabetes patients, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: loss of healthy, insulin-producing beta cells.
After just a 4-week treatment period in type 2 diabetes patients, who had previously failed standard of care (HbA1c ≥7.0% and ≤10.5%), BMF-219 demonstrated continued glycemic control at 26 weeks, or five months, after cessation of dosing. Here, a durable glycemic response (≥1.0% HbA1C reduction) was seen in 20% and 36% of patients in once daily 100 mg and 200 mg cohorts, respectively.
A general dose response was observed from BMF-219 in type 2 diabetes patients supported by dose-dependent PK response. 50mg cohort had the lowest placebo adjusted mean percent change of A1c (-0.04%) while 200mg with food cohorts achieved the highest change of A1c (-1.4%).
BMF-219 was generally well tolerated with no serious adverse events and no adverse event-related study discontinuations, and no symptomatic or clinically significant hypoglycemia.
100mg and 200mg dose levels have been selected for the first 3 Arms of the Expansion Phase, which will dose patients up to 12 weeks (compared to 4 weeks in the Escalation Phase) and extended follow-up to Week 52.
Anticipated 2024 Milestones:

On track to complete 400 mg cohort from the Escalation Phase of COVALENT-111.
On track to complete enrollment of the first three expansion cohorts of COVALENT-111 (n=216) in type 2 diabetes patients with poorly controlled diabetes and provide topline 26-week follow-up data.
COVALENT-112 (BMF-219 for Type 1 Diabetes)

Announced initial data from the first two type 1 diabetes patients dosed with BMF-219 and demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219. BMF-219 was well tolerated by both patients.
Anticipated 2024 Milestones:

On track to complete enrollment of the open label portion (n=40) of COVALENT-112 in type 1 diabetes dosed for 12 weeks with BMF-219 and provide topline 26-week follow-up data.
ONCOLOGY

COVALENT-101 (BMF-219 for Liquid Tumors)

Anticipated 2024 Milestones:

On track to complete dose escalation portion of COVALENT-101 and establish recommended Phase 2 dose (RP2D).
COVALENT-102 (BMF-219 for Solid Tumors)

Anticipated 2024 Milestones:

On track to complete dose escalation portion of COVALENT-102 and establish RP2D.
COVALENT-103 (BMF-500 for Acute Leukemias)

Anticipated 2024 Milestones:

On track to complete dose escalation portion of COVALENT-103 and establish RP2D.
FUSIONTMSYSTEM DISCOVERY PLATFORM

Continued the development of the Biomea FUSION Platform technology.
Anticipated 2024 Milestones:

On track to announce a third development candidate from the Biomea FUSION Platform technology.
FIRST QUARTER 2024 FINANCIAL RESULTS

Cash, Cash Equivalents, and Restricted Cash: As of March 31, 2024, the Company had cash, cash equivalents and restricted cash of $145.3 million, compared to $177.2 million as of December 31, 2023.
Net Income/Loss: The Company reported a net loss attributable to common stockholders of $39.1 million for the three months ended March 31, 2024, which included $5.0 million of stock-based compensation, compared to a net loss of $29.1 million for the same period in 2023, which included $3.2 million of stock-based compensation.
Research and Development (R&D) Expenses: R&D expenses were $33.8 million for the three months ended March 31, 2024, compared to $24.4 million for the same period in 2023. The increase of $9.4 million was primarily due to an increase in clinical and pre-clinical development cost and external consulting costs related to the Company’s product candidates, BMF-219 and BMF-500, as well as an increase in personnel-related costs and facilities cost due to new lease agreements for additional office and laboratory space which commenced in 2023.
General and Administrative (G&A) Expenses: G&A expenses were $7.3 million for the three months ended March 31, 2024, compared to $5.6 million for the same period in 2023. The increase of $1.6 million was primarily due to increased personnel-related expenses, including stock-based compensation.

On May 2, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported recent business progress and financial results for the first quarter ended March 31, 2024 (Press release, Bicycle Therapeutics, MAY 2, 2024, View Source [SID1234642576]).

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"During the first quarter, we focused on execution across all aspects of our business. We were pleased to initiate our Phase 2/3 Duravelo-2 registrational trial for BT8009 in metastatic urothelial cancer, and we are actively working on patient enrollment and site activation. We continue to make progress across the rest of our pipeline of differentiated, precision-guided therapeutic candidates, and look forward to a catalyst-rich second half of the year," said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics. "Additionally, I am thrilled to congratulate Mike Hannay on his promotion to Chief Product and Supply Chain Officer. Since joining the company two years ago, he has significantly advanced our manufacturing capabilities and priorities, and I look forward to seeing him excel in this new position."

First Quarter 2024 and Recent Events

Two abstracts accepted for poster presentation at the 2024 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Bicycle Therapeutics will present two abstracts highlighting the company’s clinical progress in developing Bicycle Toxin Conjugates (BTC molecules) as differentiated cancer therapies. The first abstract will examine the clinical pharmacokinetics and safety of BTC molecules, while the second abstract will outline the company’s ongoing Phase 2/3 clinical trial, called Duravelo-2, of BT8009 in metastatic urothelial cancer (mUC). ASCO (Free ASCO Whitepaper) is being held May 31-June 4 in Chicago.
Three posters presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024. Bicycle Therapeutics shared preclinical data showcasing the company’s work to develop BTC molecules for the treatment of solid tumors, Natural Killer Tumor-Targeted Immune Cell Agonist (NK-TICA) molecules that can engage NK cells to directly kill malignant tumor cells and Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) molecules that can activate the body’s immune system to enable tumor rejection. Altogether, the posters underscore the breadth of the company’s platform technology and its capabilities to produce different modalities to target cancer.
Continued progress across research and development (R&D) pipeline, with numerous clinical data readouts and program updates expected in 2H 2024. Importantly, Bicycle Therapeutics initiated the Phase 2/3 Duravelo-2 registrational trial for BT8009 in mUC, and patient enrollment is ongoing. The company continues to assess BT8009, BT5528 and BT7480 in Phase 1/2 clinical trials across a variety of tumor types, and plans to provide updates from its wholly owned Bicycle Radio Conjugate (BRC) pipeline.
Mike Hannay, D.Sc., FRPharmS, promoted to Chief Product and Supply Chain Officer. Since joining Bicycle Therapeutics in April 2022, Professor Hannay has advanced the company’s chemistry, manufacturing and controls (CMC) capabilities and drug manufacturing priorities, including preparations and buildout for the potential commercial launch of BT8009. Over the course of his career, through his work at Sanofi, Schwarz Pharma, Teva Pharmaceuticals and AstraZeneca, Professor Hannay has launched more than 40 medicines.
Participation in Upcoming Investor Conferences

Bicycle Therapeutics management will participate in a fireside chat at the Citizens JMP Life Sciences Conference on May 13, 2024, at 9 a.m. ET.

A live webcast of the fireside chat will be accessible from the Investor section of the company’s website at www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event.

First Quarter 2024 Financial Results

Cash and cash equivalents were $457.0 million as of March 31, 2024, compared to $526.4 million as of December 31, 2023. The decrease in cash and cash equivalents is primarily due to cash used in operating activities, including upfront payments associated with the initiation of our Phase 2/3 Duravelo-2 registrational trial.
R&D expenses were $34.9 million for the three months ended March 31, 2024, compared to $32.2 million for the three months ended March 31, 2023. The increase in expense of $2.7 million was primarily due to increased clinical program expenses for BT8009 development and increased personnel-related expenses. These expenses were offset by decreased clinical program expenses for Bicycle TICA molecule development and BT5528 development, as well as $8.2 million of one-time, incremental retroactive U.K. R&D tax credits.
General and administrative expenses were $16.4 million for the three months ended March 31, 2024, compared to $14.5 million for the three months ended March 31, 2023. The increase of $1.9 million was primarily due to an increase in personnel-related costs.
Net loss was $26.6 million, or $(0.62) basic and diluted net loss per share, for the three months ended March 31, 2024, compared to net loss of $39.1 million or $(1.30) basic and diluted net loss per share, for three months ended March 31, 2023.