On May 11, 2022 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the first quarter, ended March 31, 2022 (Press release, Monte Rosa Therapeutics, MAY 11, 2022, View Source [SID1234614227]).

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"Our first quarter was marked by exciting progress across our pipeline of molecular glue degraders and our proprietary QuEEN platform," said Markus Warmuth, M.D., CEO of Monte Rosa. "Last month, we presented compelling preclinical data underscoring the therapeutic potential of MRT-2359 as a potent inducer of degradation of GSPT1 in Myc-driven solid tumors, and we look forward to submitting our IND for MRT-2359 in mid-2022. We are also thrilled to work with Professor Bruno Correia and the world experts at EPFL to further realize the potential of our proprietary AI engine to identify next-generation molecular glue degraders that can eliminate therapeutically relevant proteins previously considered undruggable."

FIRST QUARTER 2022 & RECENT HIGHLIGHTS

Presented preclinical data highlighting potential of GSPT1-directed molecular glue degrader MRT-2359 to target Myc-driven cancers. The data were featured in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans. Collectively, the data support the clinical development of MRT-2359 in Myc-driven solid tumors, with an initial focus in non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

Initiated research collaboration with Dr. Correia and the Laboratory of Protein Design & Immunoengineering at EPFL. The collaboration integrates Monte Rosa’s AI engine with EPFL’s MaSIF (Molecular Surface Interaction Fingerprinting) technology. This combination will uniquely accelerate Monte Rosa’s ability to identify both novel cereblon-based MGDs and novel E3 ligases to target therapeutically relevant proteins.
UPCOMING MILESTONES & DATA PRESENTATIONS

Submission of IND application to the U.S. Food and Drug Administration (FDA) for MRT-2359 expected in mid-2022
Initiation of at least one additional lead optimization program expected in 2022
UPCOMING INVESTOR EVENTS
Monte Rosa will be participating in the following upcoming investor conferences:

UBS Global Healthcare Conference, May 23-25
Jefferies Global Healthcare Conference, June 8-10
Wells Fargo Healthcare Conference, Sept. 7-9
FIRST QUARTER 2022 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2022 were $17.9 million, compared to $9.3 million for the first quarter of 2021. These increases were due to the expansion of research and development activities, including the advancement of MRT-2359 toward clinical development, the development the company’s QuEEN platform and discovery and lead optimization efforts of its preclinical programs, as well as increased headcount and laboratory-related expenses due to the company’s continued growth as a research and development organization. R&D expenses included non-cash stock-based compensation of $1.2 million for the first quarter of 2022, compared to $0.1 million for the same period in 2021.

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2022 were $6.4 million compared to $2.2 million for the first quarter of 2021. The increase in G&A expenses was a result of increased headcount and expenses in support of the company’s growth and operations as a public company. G&A expenses included non-cash stock-based compensation of $1.1 million for the first quarter of 2022, compared to $0.2 million for the same period in 2021.

Net Loss: Net loss for the first quarter of 2022 was $23.9 million, compared to $12.3 million for the first quarter of 2021.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash and marketable securities as of March 31, 2022, were $322.5 million, compared to cash, cash equivalents and restricted cash of $351.4 million as of December 31, 2021. The decrease primarily related to cash used to fund operations of $27.4 million and cash used to purchase laboratory equipment of $1.7 million, partially off-set by proceeds from the exercise of stock options of $0.2 million. The company expects that its cash and cash equivalents will be sufficient to fund planned operations and capital expenditures into late 2024.

On May 11, 2022 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the "Company"), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that Laurent Levy, co-founder and chairman of the executive board, and Bart Van Rhijn, chief financial officer, will participate in the following conferences (Press release, Nanobiotix, MAY 11, 2022, View Source [SID1234614243]):

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UBS Global Healthcare Conference

Presentation Date: Monday, May 23rd, 2022
Time: 10:45 AM ET
Location: New York, New York, USA
H.C. Wainwright Global Investment Conference

Presentation Date: Wednesday, May 25th, 2022
Time: 8:30 AM ET
Location: Virtual and Miami, Florida, USA
A live audio webcast of each presentation will be available on the events page of the Investors section of the Company’s website. A replay will be available on the Nanobiotix website within 48 hours after each event. The Company’s corporate presentation can be downloaded here.

On May 11, 2022 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported financial results for the quarter ended March 31, 2022 (Press release, RAPT Therapeutics, MAY 11, 2022, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-first-quarter-2022-financial-results [SID1234614183]).

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"As we kick off 2022, we continue to make strong and steady progress in our programs in inflammatory diseases and oncology," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "Recently, at the American Academy of Dermatology annual meeting, we reported biomarker data from our Phase 1b clinical trial of RPT193 in atopic dermatitis that further support the clinical data we reported last June. We are now gearing up to initiate our Phase 2b clinical trial in AD this quarter and to initiate a Phase 2a trial in asthma in the second half of the year. In addition, we are continuing development of FLX475 in several oncology indications, including EBV+ lymphoma, nasopharyngeal cancer and head and neck cancer. We believe our pipeline of promising oral drugs is a key differentiator for RAPT and can serve as a foundation for growth and building stockholder value."

Financial Results for the First Quarter Ended March 31, 2022

First Quarter Ended March 31, 2022

Net loss for the first quarter of 2022 was $20.5 million, compared to $16.5 million for the first quarter of 2021.

Research and development expenses for the first quarter of 2022 were $16.7 million, compared to $13.8 million for the same period in 2021. The increase in research and development expenses was primarily due to higher costs for the RPT193 and FLX475 clinical trials, personnel and facilities, partially offset by a decrease in stock-based compensation expense.

General and administrative expenses for the first quarter of 2022 were $4.7 million, compared to $4.0 million for the same period in 2021. The increase in general and administrative expenses was primarily due to increases in personnel costs, stock-based compensation expense and facilities costs, partially offset by a decrease in consulting expenses.

As of March 31, 2022, the Company had cash, cash equivalents and marketable securities of $173.0 million.

On May 11, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the UBS 2022 Global Healthcare Conference (Press release, Quest Diagnostics, MAY 11, 2022, View Source [SID1234614211]). Steve Rusckowski, Chairman, CEO and President and Jim Davis, CEO-elect, will discuss the company’s vision, goals, and capital deployment strategies. The virtual presentation is scheduled for Tuesday, May 24, 2022, at 3:30 p.m. Eastern Time.

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The presentation and Q&A session will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 24 hours after the conclusion of the live event and will remain available until June 23, 2022.

On May 11, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the first quarter of 2022 ended March 31, 2022, and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, MAY 11, 2022, View Source [SID1234614228]).

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"Pieris and our partners have made steady progress across the pipeline over the past quarter, and we are reiterating guidance on both cinrebafusp alfa phase 2 data in HER2-high gastric cancer in 2023 and PRS-220 clinical initiation this year. With IND acceptance for PRS-344/S095012, enrollment continues as planned and, separately, we are expecting an IND filing for PRS-342/BOS-342 in the next 12 months. At the same time, geopolitical and pandemic-driven challenges are affecting enrollment on certain programs. We are announcing a heightened risk to maintaining current guidance on reporting topline results for PRS-060/AZD1402 this year, despite AstraZeneca’s continued commitment to execute on this program. Additionally, more time is needed for the enrollment of the HER2-low arm for cinrebafusp alfa. Notwithstanding these challenges, with our efficient program funding strategies and committed alliance partners, Pieris can advance its core assets with sufficient cash reach beyond the efficacy readout for PRS-060/AZD1402, which will be a significant milestone for us," said Stephen S. Yoder, President and Chief Executive Officer of Pieris.

•PRS-060/AZD1402 and AstraZeneca Collaboration: Enrollment continues for part 2a (efficacy of 1 mg and 3 mg cohorts) and part 1b (safety of 10 mg cohort) of the multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated PRS-060/AZD1402, an IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Given the geopolitical situation, along with broader challenges amidst an ongoing pandemic, there is a heightened risk that more time will be required to deliver the topline study results by the end of the year as planned. AstraZeneca is currently in the process of conducting a thorough timeline reforecast and working on strategies to mitigate any potential delays. Upon completion of the study, which is being sponsored and funded by AstraZeneca, Pieris may choose to exercise its co-development option, which would be on a 25% cost-share basis with a cost cap or a 50% cost-share basis without a cost cap. Separately, Pieris will have a future option to co-commercialize PRS-060/AZD1402 in the United States.
•Cinrebafusp Alfa (PRS-343): Enrollment continues in the two-arm, multicenter, open-label phase 2 study of cinrebafusp alfa, a 4-1BB/HER2 Anticalin-based bispecific for the treatment of HER2-expressing gastric cancer. The first arm of the study is evaluating the efficacy, safety, and tolerability of cinrebafusp alfa in combination with standard of care agents ramucirumab and paclitaxel in patients with HER2-high gastric cancer. The Company is reiterating its guidance and expects to report data from this arm in 2023. The second arm of the study is evaluating the efficacy, safety, and tolerability of cinrebafusp alfa in combination with tucatinib in patients with HER2-low gastric cancer. The Company is revising its guidance and now expects to report data from this arm next year due to slower than anticipated enrollment.

•PRS-344/S095012 and Servier Collaboration: Enrollment continues and now includes the U.S., where Pieris holds exclusive commercialization rights, in the phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 Anticalin-based bispecific for the treatment of solid tumors that Pieris is developing in collaboration with Servier. Pieris also will receive royalties on any ex-U.S. sales for this program. Additionally, Servier is continuing development of PRS-352/S095025, an OX40/PD-L1 bispecific, for which the companies recently presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting 2022. PRS-352/S095025 has demonstrated superior potency to anti-PD-L1 and combination OX40 and PD-L1 therapy benchmarks in different in vitro assays, inhibits the PD-1/PD-L1 pathway with comparable potency to anti-PD-L1 antibodies, stimulates human CD4 T cells,

drives T cell stimulation in ex vivo cynomolgus monkey assays, and demonstrated an antibody-like PK profile in vivo.
•PRS-220: PRS-220, a proprietary inhaled Anticalin protein targeting connective tissue growth factor for the treatment of IPF, remains on track to enter a phase 1 trial in healthy volunteers this year.
•PRS-342/BOS-342: Boston Pharmaceuticals continues to advance PRS-342/BOS-342, a 4-1BB/GPC3 bispecific, towards the clinic, with an IND filing expected within the next 12 months.

First Quarter Financial Update:
Cash Position – Cash, cash equivalents and investments totaled $100.3 million for the quarter ended March 31, 2022, compared to a cash and cash equivalents balance of $117.8 million for the quarter ended December 31, 2021. The decrease is due to funding operations in 2022. The Company believes reported cash is sufficient to fund operations into the fourth quarter of 2023.
R&D Expense – R&D expenses were $14.1 million for the quarter ended March 31, 2022, compared to $16.6 million for the quarter ended March 31, 2021. The decrease is due to lower program costs, as work related to the Company’s sponsored phase 1 trial of PRS-060/AZD1402 was largely complete in 2021, and due to lower manufacturing costs for cinrebafusp alfa. These lower costs were partially offset by higher clinical costs for cinrebafusp alfa and higher clinical and manufacturing costs for PRS-344/S095012. Separately, higher personnel costs due to higher headcount were partially offset by a reduction in consulting and other professional service costs.
G&A Expense – G&A expenses were $4.4 million for the quarter ended March 31, 2022, compared to $4.1 million for the quarter ended March 31, 2021. The increase was driven primarily by higher non-cash amortization of deferred costs related to collaboration revenue earned and partially offset by slightly lower legal and audit costs.
Other Income – For the quarter ended March 31, 2022, $2.1 million of grant income was recorded on PRS-220.
Net Loss – Net loss was $5.1 million or $(0.07) per share for the quarter ended March 31, 2022, compared to a net loss of $4.2 million or $(0.07) per share for the quarter ended March 31, 2021.
Conference Call:
Pieris management will host a conference call beginning at 8:00 AM EDT on Wednesday, May 11, 2022, to discuss the first quarter financial results and provide a corporate update. Individuals can join the call by dialing (888) 428-7458 (US & Canada) or (862) 298-0702 (International). Alternatively, a listen-only audio webcast of the call can be accessed here.
For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.