SpringWorks Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Business Highlights

On February 28, 2023 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported financial results for the fourth quarter and full-year periods ended December 31, 2022 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, FEB 28, 2023, View Source [SID1234627877]).

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"2022 was a pivotal year for SpringWorks. We delivered highly positive data from our Phase 3 DeFi trial of nirogacestat in desmoid tumors, which served as the basis for our New Drug Application that was recently accepted by the FDA and granted Priority Review. We are excited to have the opportunity to change the treatment landscape for the desmoid tumor community following an anticipated approval later this year," said Saqib Islam, Chief Executive Officer of SpringWorks. "We are equally encouraged by the potential for mirdametinib to be a best-in-class therapy for children and adults with NF1-PN. We look forward to reporting topline data from our Phase 2b ReNeu trial this year, which could support an NDA submission in the first half of 2024, and to advancing our emerging portfolio of BCMA combinations in multiple myeloma and biomarker-defined metastatic solid tumor programs. We believe that our continued strong execution, a financial position that we expect will fund us well into 2026, and durable intellectual property protections for our lead assets will support our long-term growth as we work towards our ambition of achieving two product launches by 2025."

Recent Business Highlights and Upcoming Milestones

Rare Oncology

In February 2023, the U.S. Food and Drug Administration (FDA) accepted SpringWorks’ New Drug Application (NDA) for nirogacestat, an investigational oral, small molecule gamma secretase inhibitor, in development as a monotherapy for the treatment of adults with desmoid tumors. The application has been granted Priority Review and given a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2023. In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application. SpringWorks also expects to file a Marketing Authorization Application for nirogacestat with the European Medicines Agency in 2024.
In the fourth quarter of 2022, the Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors met its accrual goal.
In the fourth quarter of 2022, SpringWorks participated in a Type C meeting with the FDA to align on the statistical analysis plan for the Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN) and expectations for an anticipated NDA submission in this indication. SpringWorks expects to present topline data from the pediatric and adult cohorts of the Phase 2b ReNeu trial of mirdametinib in NF1-PN in the second half of 2023. Pending these data, SpringWorks anticipates submitting an NDA for mirdametinib as a treatment for NF1-PN in the first half of 2024.
Patients continue to be enrolled in a Phase 2 trial evaluating nirogacestat in ovarian granulosa cell tumors.
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

SpringWorks continues to advance nirogacestat as a potential cornerstone of BCMA combination therapy across modalities in collaboration with industry leaders. In 2023, SpringWorks expects that additional clinical data of nirogacestat in combination with BCMA-directed therapies will be presented and that additional planned Phase 1 collaborator studies will be initiated.
Biomarker-Defined Metastatic Solid Tumors

The Phase 1 trial evaluating BGB-3245, a selective RAF dimer inhibitor, as a monotherapy in adult patients with RAF mutant solid tumors is advancing into cohort expansion studies. SpringWorks expects data from this trial to be presented at a medical conference in the first half of 2023. In February 2023, the first patient was dosed in a Phase 1/2a combination study of BGB-3245 and mirdametinib. BGB-3245 is being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene.
The BeiGene-sponsored Phase 1b/2 clinical trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in adult patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors is ongoing. SpringWorks expects data from this trial to be presented at a medical conference in the first half of 2023.
In the fourth quarter of 2022, SpringWorks nominated TEAD inhibitor development candidate, SW-682. The Company expects to present additional preclinical data of SW-682 at a medical conference in the first half of 2023 and to file an Investigational New Drug Application for SW-682 in 2023.
General Corporate

SpringWorks has expanded and strengthened its intellectual property portfolio, including a new patent issued by the United States Patent and Trademark Office (USPTO) in November 2022 directed to pharmaceutical compositions of nirogacestat (U.S. Patent No. 11,504,354), which expires in 2042 and represents the seventh Orange Book-listable patent for nirogacestat. In addition, in February 2023, the USPTO granted a new patent directed to dispersible formulations of mirdametinib (U.S. Patent No. 11,571,402), which expires in 2041; this patent covers the formulation of mirdametinib that is being developed for pediatric patients with NF1-PN.
Fourth Quarter and Full Year 2022 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $37.9 million and $146.1 million for the 2022 fourth quarter and full-year periods, respectively, compared to $29.3 million and $101.7 million for the comparable periods of 2021. The increase in R&D expense for the 2022 full-year period was primarily attributable to a $31.8 million increase in internal costs driven by the growth in employee costs associated with increases in the number of personnel, including an increase in stock-based compensation expense, and an increase of $22.6 million in external costs related to drug manufacturing, clinical trial and other research, with the full year increase partially offset by an $11.0 million decrease in licensing costs related to the nonrefundable upfront payment to Katholieke Universiteit Leuven and the Flanders Institute for Biotechnology for the in-licensing of the TEAD inhibitor program in May 2021.
General and Administrative (G&A) Expenses: G&A expenses were $40.5 million and $134.6 million for the 2022 fourth quarter and full-year periods, respectively, compared to $26.5 million and $71.8 million for the comparable periods of 2021. The increase in G&A expense was primarily attributable to an increase in internal costs driven by the growth in employee costs associated with increases in the number of personnel, including an increase in stock-based compensation expense as we continue to expand our operations to support the organization, and an increase in information technology costs and consulting and professional services, including legal, regulatory and compliance, as we continue to build new capabilities, including commercial.
Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $74.2 million, or $1.19 per share, for the fourth quarter of 2022 and a net loss of $277.4 million, or $5.21 loss per share, for the year ended December 31, 2022. This compares to a net loss of $56.1 million, or $1.15 per share, for the fourth quarter of 2021 and a net loss of $173.9 million, or $3.59 per share for the year ended December 31, 2021.
Cash Position: Cash, cash equivalents and marketable securities were $597.0 million as of December 31, 2022.

Schrödinger Reports Strong Fourth Quarter and Full-Year 2022 Financial Results

On February 28, 2023 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, reported financial results for the fourth quarter and full-year ended December 31, 2022, and provided its financial outlook for 2023 (Press release, Schrodinger, FEB 28, 2023, View Source [SID1234627876]).

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"We are very pleased with our performance across all areas of our business last year, with strong fourth quarter 2022 software revenue growth even in a challenging macroeconomic environment. Drug discovery revenue for 2022 nearly doubled compared to the prior year, our portfolio advanced and expanded, and we added two new collaborations," stated Ramy Farid, Ph.D., chief executive officer of Schrödinger. "Looking ahead, we are focused on our strategic priorities of driving continued growth in use of our technology, further enhancing the capabilities of our platform, and advancing our collaborative and proprietary pipeline. We are already making important progress on these priorities, and today we announced the selection of our Wee1 development candidate, SGR-3515, and have initiated IND-enabling studies for this program."

"We are pleased that we overcame several headwinds specific to our business in 2022 to deliver strong fourth quarter and full-year financial results. Our software revenue growth was driven by larger renewals from existing customers, including collaborators who significantly scaled up their adoption of our software in their internal discovery programs, and accelerated renewal of multi-year agreements," stated Geoff Porges, MBBS, chief financial officer of Schrödinger. "We expect both software and drug discovery to contribute to revenue growth this year. With significant operating leverage emerging from our business and a strong balance sheet, we are very well positioned for continued growth and investment in the unique opportunities offered by our technology platform."

Fourth Quarter 2022 Financial Results
•Total revenue for the fourth quarter increased 23% to $56.8 million, compared to $46.2 million in the fourth quarter of 2021.
•Software revenue for the fourth quarter increased 24% to $47.8 million, compared to $38.6 million in the fourth quarter of 2021. Multi-year agreements contributed significantly to revenue in the quarter and approximated the contribution to reported revenue from such agreements in the fourth quarter of 2021.
•Drug discovery revenue was $9.0 million for the fourth quarter, compared to $7.6 million in the fourth quarter of 2021.
•Software gross margin increased to 83% for the fourth quarter, compared to 78% in the fourth quarter of 2021.
•Operating expenses were $67.2 million for the fourth quarter, compared to $48.9 million for the fourth quarter of 2021.
•Other income, which includes changes in fair value of equity investments and interest income/expense, was $1.2 million for the fourth quarter, compared to other expense of $7.9 million for the fourth quarter of 2021.
•Net loss for the fourth quarter was $27.2 million, compared to $30.7 million in the fourth quarter of 2021.

Three Months Ended
December 31,
2022 2021 % Change
(in millions)
Total revenue $ 56.8 $ 46.2 23%
Software revenue 47.8 38.6 24%
Drug discovery revenue 9.0 7.6 19%
Software gross margin 83 % 78 %
Operating expenses $ 67.2 $ 48.9 38%
Other income (expense) $ 1.2 $ (7.9) (115)%
Net loss $ (27.2) $ (30.7) (11)%

Full Year 2022 Financial Results
•Total revenue for the full year increased 31% to $181.0 million, compared to $137.9 million for 2021.
•Software revenue for the full year 2022 increased 20% to $135.6 million, compared to $113.2 million for 2021, with multi-year agreements making a similar contribution to reported revenue to the contribution in 2021 and 2020.
•Drug discovery revenue for the full year was $45.4 million for the full year 2022, compared to $24.7 million for 2021.
•Software gross margin was 78% for the full year, compared to 77% for 2021.
•Operating expenses were $247.8 million for the full year, compared to $177.1 million for 2021.
•Other expense, which includes gains/loss on equity investments, changes in fair value of such investments and interest income/expense, was $2.3 million for the full year, compared to other income of $10.6 million for 2021.
•Net loss for the full year was $149.2 million, compared to $101.2 million for 2021.
•At December 31, 2022, Schrödinger had cash, cash equivalents, restricted cash and marketable securities of approximately $456 million, compared to approximately $479 million at September 30, 2022.

Twelve Months Ended
December 31,
2022 2021 % Change
(in millions)
Total revenue $ 181.0 $ 137.9 31%
Software revenue 135.6 113.2 20%
Drug discovery revenue 45.4 24.7 84%
Software gross margin 78 % 77 %
Operating expenses $ 247.8 $ 177.1 40%
Other income (expense) $ (2.3) $ 10.6 (122)%
Net loss $ (149.2) $ (101.2) 47%

Full Year 2022 Key Performance Indicators (KPIs)
Schrödinger today reported 2022 key performance indicators for both the software and drug discovery components of its business.

Software. Total annual contract value (ACV) increased 25% to $140.6 million, and the ACV of Top 10 customers increased 36% to $46.5 million. The number of customers with an ACV over $5 million increased to four from two customers, the number of customers with an ACV over $1 million increased to 18 from 15, and the number of customers with an ACV over $100,000 increased 19% to 227. Schrödinger’s customer retention rate in 2022 was 96%, and the company ended the year with 1,748 customers with an ACV ov her $1,000.

Drug discovery. Schrödinger ended 2022 with 15 ongoing programs eligible for royalties, up from 13 the previous year. For the year ended December 31, 2022, the number of collaborators since 2018 increased to 17 from 15.

Software KPI 2022 2021
Total annual contract value (ACV) $140.6 million $112.1 million
ACV of Top 10 customers $46.5 million $34.1 million
Number of customers over $5M in ACV 4 2
Number of customers over $1M in ACV 18 15
Number of customers over $100,000 in ACV 227 190
Customer retention over $100,000 ACV 96% 98%
Number of active customers with ACV over $1,000 1,748 1,647

Drug Discovery KPI 2022 2021
Ongoing programs eligible for royalties 15 13
Number of collaborators since 2018 17 15

For additional information about our KPIs, see "Operating Metrics" below.

2023 Financial Outlook
As of February 28, 2023, Schrödinger provided the following expectations for the fiscal year ending December 31, 2023:
•Software revenue growth is expected to be in the range of 13 to 17 percent
•Drug discovery revenue is expected to range from $70 million to $90 million
•Software gross margin is expected to be similar to software gross margin for the full year 2022
•Operating expense growth in 2023 is expected to be significantly lower than operating expense growth in 2022 and to be similar to revenue growth in 2023
•Cash used for operating activities in 2023 is expected to be below cash used for operating activities in 2022

For the first quarter of 2023, software revenue is expected to range from $31 million to $35 million, and drug discovery revenue is expected to range from $30 million to $34 million.

Recent Highlights
Corporate
•In February, Schrödinger reported the receipt of an approximately $111.3 million cash distribution from Nimbus Therapeutics in connection with Takeda’s acquisition of Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858. Schrödinger expects to receive a second distribution of approximately $36.0 million, also related to Takeda’s $4.0 billion upfront payment to Nimbus, in the second quarter of 2023, for a total distribution of approximately $147.3 million. NDI-034858 is being evaluated for the treatment of multiple autoimmune diseases following positive Phase 2b results in psoriasis. The distribution was on account of Schrödinger’s equity stake in Nimbus, which as of December 31, 2022, was 3.8% on a fully diluted basis.

•In February, Structure Therapeutics, Inc., a collaborator focused on developing novel oral small molecule therapeutics for metabolic and pulmonary diseases, completed an initial public offering for gross proceeds of $185.3 million. Schrödinger participated in the IPO and now holds a 3.7 percent equity stake in Structure Therapeutics.

•In January, Schrödinger announced that it amended its discovery, development and commercialization collaboration with Bristol Myers Squibb to include a new discovery program in neurology. Schrödinger received an additional upfront payment for the new program and is eligible to receive discovery, development and commercialization milestones, as well as royalties on net sales, similar to the terms of the original agreement.

•In January, Schrödinger and Otsuka Pharmaceutical Co., Ltd. announced an innovative multi-part agreement that includes a collaboration to discover molecules for an emerging CNS disease target, as well as a knowledge-transfer agreement and an expanded licensing agreement to deploy Schrodinger’s technology platform at scale in Otsuka’s new drug discovery center in Osaka. Schrödinger received an upfront payment and will be eligible to receive discovery, development and regulatory milestones, as well as tiered royalties on net sales of any products emerging from the drug discovery collaboration in all markets.

Pipeline
•Schrödinger is advancing its MALT1 inhibitor, SGR-1505, in Phase 1 clinical development. A dose-escalation study designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and early signals of clinical activity of SGR-1505 as a monotherapy is open to enrollment in patients with relapsed or refractory B-cell malignancies.

•Schrödinger announced today that it has selected SGR-3515 as its development candidate for its Wee1 program. SGR-3515 demonstrated strong anti-tumor activity with limited off-target effects in preclinical studies. Activities to support IND-enabling studies are underway.

•Schrödinger is continuing to progress its CDC7 inhibitor, SGR-2921, through IND-enabling studies to support a planned IND submission this year. In December, the company presented data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrating that SGR-2921 exhibited strong anti-tumor activity as a monotherapy and in combination with standard of care agents in multiple preclinical tumor models.

•Today, Schrödinger announced that it is expecting the first program from the Bristol Myers Squibb collaboration to advance to development candidate status. Following finalization of this advancement, Schrödinger will recognize a drug discovery milestone associated with advancement of the program, which is projected in the first quarter of 2023.

•In January, Schrödinger announced a new proprietary program targeting LRRK2, a genetically validated target with therapeutic potential for the treatment of Parkinson’s disease. Schrödinger has generated cryo-EM structures of LRRK2 which is helping to accelerate the identification of novel LRRK2 inhibitors.

Platform
•Schrödinger scientists continued to advance the company’s platform, and recently published research highlighting a computational, physics-based approach to enable accurate prediction of brain penetrant molecules. This computational advancement is being leveraged in Schrödinger’s programs in neurology.

•In a collaborative effort with AbbVie, Schrödinger and AbbVie scientists published research demonstrating in silico methods to accurately predict the oxidation risk of residues in monoclonal antibodies, a characteristic that is critical to understand during antibody discovery and development.

•Scientists at L’Oréal and Schrödinger recently published research highlighting the potential of molecular dynamics simulations to study the interactions between complex polymers and biological substrates, such as hair. The research is expected to play an increasingly important role in advancing eco-friendly polymer formulation design.

•Schrödinger reported that it appointed Pratyush Tiwary, Ph.D., to its scientific advisory board. Dr. Tiwary’s research is at the interface of computational chemistry and machine learning, underscoring Schrödinger’s commitment to further integrate next-generation machine learning methods with highly predictive atomistic simulations. Dr. Tiwary is an associate professor at the University of Maryland, College Park in the Department of Chemistry and Biochemistry and the Institute for Physical Science and Technology. He is also an affiliated faculty member of Applied Mathematics, Biophysics, Chemical Physics and Materials Science and Engineering.

Webcast and Conference Call Information
Schrödinger will host a conference call to discuss its fourth quarter and full year 2022 financial results on Tuesday, February 28, 2023, at 4:30 p.m. ET. The live webcast can be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source To participate in the live call, please register for the call here. It is recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will receive the dial-in information. The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Prothena has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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Rigel Announces Conference Call and Webcast to Report Fourth Quarter and Full Year 2022 Financial Results and Business Update

On February 28, 2023 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that it will report its fourth quarter and full year 2022 financial results after market close on Tuesday, March 7, 2023 (Press release, Rigel, FEB 28, 2023, View Source [SID1234627874]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.

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Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

Repare Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2022 Financial Results

On February 28, 2023 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Repare Therapeutics, FEB 28, 2023, View Source [SID1234627873]).

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"We made substantial progress advancing our innovative, synthetic lethality-based pipeline across multiple programs in 2022, including entering into a worldwide collaboration agreement with Roche to develop camonsertib, receiving Fast Track designation from the FDA for our first-in-class PKMYT1 inhibitor RP-6306, and advancing our preclinical programs," said Lloyd M. Segal, President and Chief Executive Officer of Repare." We expect 2023 to be another productive year for Repare across the portfolio, with early clinical readouts for both camonsertib and RP-6306 in the first half of 2023. In addition, we are poised to expand our pipeline leveraging our proprietary SNIPRx platform, and look forward to sharing more information on our third clinical program this summer."

2022 Highlights and 2023 Outlook:

•
Advancing camonsertib, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of tumors with specific synthetic lethal genomic alterations in partnership with Roche.
o
Initial data from the Phase 1/2 trials evaluating camonsertib in combination with three poly (ADP-ribose) polymerase (PARP) inhibitors is expected to be presented in the first half of 2023 at a major medical meeting.
o
The Company expects to report initial data from the Phase 1/2 TRESR trial evaluating camonsertib in combination with gemcitabine in the summer or fall of 2023.
•
Evaluating RP-6306, a first-in-class, oral PKMYT1 inhibitor as a monotherapy and in combinations in multiple early clinical studies.
o
The Company expects to report initial Phase 1 clinical data for RP-6306 as a monotherapy for the treatment of molecularly selected advanced solid tumors (MYTHIC) in the first half of 2023. The Company expects to report initial Phase 1 clinical data for RP-6306 as a combination therapy for the treatment of molecularly selected advanced solid tumors in the fourth quarter of 2023.
o
In the fourth quarter of 2022, the U.S. Food and Drug Administration (FDA) granted Fast Track designation (FTD) to RP-6306 in combination with gemcitabine for the treatment of adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A mutated platinum resistant ovarian cancer. FTD is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to reach patients earlier.
o
Based on promising preclinical data released at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in October 2022, Repare is working with clinical investigators to initiate clinical testing, as part of an investigator-sponsored trial (IST), of a fourth new RP-6306 combination with carboplatin, with first patient dosing expected in the first half of 2023.

o
In the fourth quarter of 2022, Repare entered into an agreement with Canadian Cancer Trials Group (CCTG) for a planned, basket Phase 2 IST to evaluate RP-6306 in patients with selected, advanced cancers receiving standard agents. A sub-study under the master clinical trial protocol will evaluate RP-6306 in combination with gemcitabine in patients with CD4/6i-resistant ER+/HER2- metastatic breast cancer.
•
Advancing preclinical programs into clinical development.
o
Repare expects to initiate IND-enabling studies in the first half of 2023 for a small molecule against an undisclosed target with potential to enter the clinic in late 2023 or early 2024, which represents an acceleration from the Company’s prior expectations for this program.
o
Repare is pursuing development of an inhibitor of polymerase theta (Polθ) in collaboration with Ono Pharmaceutical Company Ltd (Ono) in Japan, South Korea, Taiwan, Hong Kong, Macau and ASEAN countries, excluding mainland China. Repare retains all rights to develop and commercialize the products outside the Ono territory. In 2022, the Company selected a proposed inhibitor of Polθ, which it designated as RP-2119. In February 2023, based on its review of ongoing preclinical studies, Repare elected to prioritize other Polθ inhibiting compounds in its preclinical development portfolio, which it believes have a higher probability for clinical impact relative to RP-2119. The Company is now guiding toward clinical entry for a Polθ inhibitor in 2024.
o
In January 2023, Repare received an approximate $1.5 million (¥200 million) milestone payment from Ono. The payment reflected the achievement of a research milestone under the Company’s research services, license and collaboration agreement with Ono (Ono Agreement).
o
Also in January 2023, Repare and Ono amended the Ono Agreement to further extend the research term until July 31, 2023. Previously, Repare had entered into an amendment with Ono in October 2021 to extend the research term by one year at no additional cost to Repare.
Fourth Quarter and Full Year 2022 Financial Results:

•
Cash and cash equivalents and marketable securities: Cash and cash equivalents and marketable securities as of December 31, 2022 were $343.9 million, which Repare believes will be sufficient to fund its planned operations into 2026.
•
Revenue from collaboration agreements: Revenue from collaboration agreements were $18.2 million and $131.8 million for the three- and twelve-month periods ended December 31, 2022, respectively, as compared to $6.9 million and $7.6 million for the three- and twelve-month periods ended December 31, 2021, due to revenue recognized from our collaboration and license agreement with Roche.
•
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $29.9 million and $119.1 million for the three- and twelve-month periods ended December 31, 2022, respectively, as compared to $28.0 million and $90.0 million for the three- and twelve-month periods ended December 31, 2021 due to an increase in development activities related to the advancement of the RP-6306 program and preclinical activities related to pipeline programs; an increase of personnel-related costs, including share-based compensation, for increased headcount in support of discovery and development activities; and other research and development costs. Camonsertib costs were similar on a year over year basis and decreased quarter over quarter following the transfer of CMC related activities to Roche pursuant to the collaboration agreement.

•
General and administrative (G&A) expenses: G&A expenses were $7.9 million and $32.6 million for the three- and twelve-month periods ended December 31, 2022, respectively, as compared to $7.6 million and $26.2 million for the three- and twelve-month periods ended December 31, 2021. The increase in G&A expenses for the three- and twelve-month periods were primarily due to higher personnel related costs, including share-based compensation; an increase in professional fees associated with the Roche collaboration agreement and the establishment of our at-the-market (ATM) offering, as well as timing of audit and SOX compliance efforts, partially offset by a decrease in our D&O insurance premium.
•
Net loss: Net loss was $31.7 million, or $0.75 per share, and $29.0 million, or $0.69 per share, for the three- and twelve-month periods ended December 31, 2022, respectively, and $28.3 million, or $0.70 per share and $106.9 million, or $2.83 per share, for the three- and twelve-month periods ended December 31, 2021, respectively.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.