On May 5, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported financial results and provided business updates for the three months ended March 31, 2022 (Press release, Dynavax Technologies, MAY 5, 2022, View Source [SID1234613653]).

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Ryan Spencer, Chief Executive Officer of Dynavax, commented: "Following a year of record revenue for both HEPLISAV-B vaccine and CpG 1018 adjuvant, 2022 is off to a great start and has the potential to be another pivotal year. In the first quarter, HEPLISAV-B grew 21% compared to the fourth quarter, exceeding the overall hepatitis B market growth of 14%. The first quarter also marked another quarter of significant revenue for CpG 1018 adjuvant supply for COVID-19 vaccines as we continue to demonstrate strong execution across our portfolio of commercial supply agreements. Looking ahead, we are on track to achieve our second consecutive profitable year with continued revenue growth fueled by HEPLISAV-B and our CpG 1018 adjuvant supply business. This year we also expect additional clinical data readouts from both of our Phase 1 pipeline programs for Tdap and shingles."

FIRST-QUARTER CORPORATE HIGHLIGHTS

HEPLISAV-B Vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted]

HEPLISAV-B vaccine is the first and only U.S. FDA-approved adult hepatitis B vaccine that enables series completion with only two doses in one month.

•HEPLISAV-B vaccine achieved net product revenue of $20.8 million for the first quarter of 2022, up 151% compared to $8.3 million for the first quarter of 2021.
•Market share in the accounts targeted by the Dynavax field sales team was approximately 33%, with a total market share of approximately 26% in the first quarter of 2022, up from approximately 27% and 14%, respectively, in the first quarter of 2021.
•The CDC’s Advisory Committee on Immunization Practices (ACIP) recommendation for hepatitis B vaccination in adults has been published (link), advising that all adults aged 19-59 should be vaccinated against hepatitis B. Dynavax believes this will enable a significantly expanded total market opportunity of up to $800 million in the U.S. by 2027, with HEPLISAV-B well positioned to secure a majority market share over time.

CpG 1018 Adjuvant Supply for COVID-19 Vaccines

Dynavax has established a global portfolio of CpG 1018 adjuvant commercial supply agreements currently focused on the development of COVID-19 vaccines across a variety of vaccine platforms.

•CpG 1018 adjuvant revenue for the first quarter of 2022 was $91.5 million, up 23% compared to $74.6 million for the first quarter of 2021.
•The Company continues to expect 2022 full-year CpG 1018 adjuvant COVID-19 supply revenue to be at least $550 million, based on committed adjuvant orders, with full-year gross margin anticipated to be approximately 50%. Revenue and margins are expected to fluctuate quarter to quarter based on customer mix and timing of product delivery.

•CpG 1018 adjuvant supply partner selected recent regulatory updates:
oBiological E (Bio E) has received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI) for its subunit COVID-19 vaccine candidate, CORBEVAX utilizing CpG 1018 adjuvant, for adults (December 2021), for adolescents aged 12 to less than 18 years of age (February 2022) and for use in children ages 5-12 (April 2022).
oClover Biopharmaceuticals has reported it is in the process of submitting conditional regulatory approval applications for its protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum) utilizing CpG 1018 adjuvant. Clover anticipates that its submissions are to be completed in mid-2022 for the China NMPA and by the third quarter of 2022 for the WHO and EMA.
oMedigen Vaccine Biologics Corporation received EUA for MVC-COV1901, its COVID-19 vaccine candidate utilizing CpG 1018 adjuvant, from the Taiwan Food and Drug Administration in 2021 and from Paraguay’s National Directorate of Health Surveillance (DINAVISA) in February 2022.
oValneva SE recently announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for its COVID-19 vaccine candidate, VLA2001 utilizing CpG 1018 adjuvant. Valneva also reported that it now expects a decision from CHMP on its recommendation for potential conditional approval by the European Medicines Agency (EMA) in the second quarter of 2022.

Clinical Pipeline

Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.

•Tdap vaccine program: Interim adult data from the ongoing Phase 1 study evaluating a new Tdap vaccine candidate utilizing CpG 1018 adjuvant demonstrated it was safe and well tolerated with immunogenicity data supporting continued advancement. Adolescent data from the same trial is expected in the second half of 2022.
•Shingles vaccine program: Topline data from an ongoing Phase 1 study evaluating the safety, tolerability, and immunogenicity in adults compared to Shingrix, the leading marketed shingles vaccine in the U.S., is anticipated by the end of 2022.
•Plague vaccine Phase 2 study: In collaboration with, and funded by, the U.S. Department of Defense, the Company plans to initiate a Phase 2 clinical trial in the second half of 2022.

FIRST-QUARTER FINANCIAL HIGHLIGHTS

Total Revenues and Product Revenue, Net.

Total revenues for the first quarter of 2022 were $114.0 million, compared to $83.3 million for the first quarter of 2021.

•HEPLISAV-B vaccine product revenue, net was $20.8 million for the first quarter of 2022, compared to $8.3 million for the first quarter of 2021.
•CpG 1018 adjuvant product revenue, net was $91.5 million in the first quarter of 2022 compared to $74.6 million in the first quarter of 2021.
Cost of Sales – Product. Cost of sales – product for the first quarter of 2022 increased to $40.0 million, compared to $24.6 million for the first quarter of 2021. The increase was primarily due to manufacturing costs for increased volumes of CpG 1018 adjuvant sold to COVID-19 supply partners and increased HEPLISAV-B vaccine sales volume.

Research and Development Expenses (R&D). R&D expenses for the first quarter of 2022 increased to $11.1 million, compared to $7.8 million for the first quarter of 2021. The increase was primarily driven by higher compensation and personnel costs, including non-cash stock-based compensation, associated with higher headcount and higher external costs as the Company continued to invest in its product candidates with CpG 1018 adjuvant through pre-clinical and clinical collaborations and additional discovery efforts.

Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the first quarter of 2022 increased to $32.2 million, compared to $22.4 million for the first quarter of 2021. The increase was primarily driven by compensation and related personnel costs, including non-cash stock-based compensation, primarily associated with increased headcount as the Company expanded its field sales team to support HEPLISAV-B vaccine commercialization in mid-2021.

Interest Expense. Interest expense was $1.7 million in the first quarter of 2022, a decrease of $3.0 million from $4.7 million in the first quarter of 2021, reflecting a decreased interest rate associated with the Company’s convertible senior notes due 2026.

Other income (expense). Other income (expense) includes the change in fair value of warrant liability which is a non-cash adjustment to fair value each reporting period. The change in fair value of warrant liability for the first quarter of 2022 resulted in a gain of $1.8 million, compared to a loss of $25.6 million in the first quarter of 2021 due to the final mark-to-market adjustment from January 1, 2022, through the expiration date of the warrants on February 12, 2022. There were no warrants outstanding as of March 31, 2022.

Net Income. GAAP net income was $32.9 million, or $0.26 per share (basic) and 0.22 per share (diluted) in the first quarter of 2022, compared to GAAP net income of $0.9 million, or $0.01 per share (basic and diluted) in the first quarter of 2021.

2022 Financial Guidance

Dynavax anticipates 2022 revenues, operating expenses, and other costs to be in the ranges shown below, unchanged from the Company’s previous financial guidance provided on February 28, 2022:

•Full-year CpG 1018 adjuvant net product revenues of at least $550 million, with an associated gross margin of approximately 50%
•Research and development expenses to be between approximately $55 – $70 million
•Selling, general and administrative expenses to be between approximately $120 – $140 million
•Interest expense of approximately $7 million

Conference Call and Webcast Information

Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 4282730. A replay of the webcast will be available for 30 days following the live event.

About Hepatitis B

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, I and transmission are on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommends that adults aged 19–59 years and adults aged ≥60 years with risk factors for hepatitis B should receive HepB vaccines, and that adults aged ≥60 years without known risk factors for hepatitis B may receive HepB vaccines.iii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults aged 19 to 59 with diabetes as soon as possible after their diagnosis, and for people aged 60 and older with diabetes at their physician’s discretion. iii Approximately 26 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year. iv

About HEPLISAV-B Vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted]

HEPLISAV-B vaccine is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 adjuvant to enhance the immune response. Dynavax wholly owns HEPLISAV-B.

Important U.S. Product Information

HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

For full U.S. Prescribing Information for HEPLISAV-B, click here.

Important U.S. Safety Information (ISI)

Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%).

About CpG 1018 Adjuvant

Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response with an improved tolerability profile, which has been demonstrated in HEPLISAV-B vaccine and multiple COVID-19 vaccines that have received Emergency Use Authorization outside of the U.S. CpG 1018 adjuvant provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of novel or improved vaccines.

On May 5, 2022 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, reported the Company will release its first quarter 2022 financial results before the market opens on Thursday, May 12, 2022 (Press release, Synlogic, MAY 5, 2022, View Source [SID1234613668]). The press release will be followed by a conference call at 8:30 am ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a business update.

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The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 5149412. Participants may access the live webcast in the "Events Calendar" of the Investors & Media section

On May 5, 2022 Keros Therapeutics, Inc. ("Keros" or the "Company") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, reported financial results for the quarter ended March 31, 2022 (Press release, Keros Therapeutics, MAY 5, 2022, View Source [SID1234613684]).

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"The first quarter of fiscal 2022 saw positive momentum across all of our programs," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "We remain on track to report additional data from our ongoing Phase 2 clinical trial of KER-050 in patients with myelodysplastic syndromes ("MDS") in mid-2022, as well as to report initial data from Part 1 of our ongoing Phase 1 clinical trial of KER-012 in healthy volunteers in the second quarter of 2022."

First Quarter 2022 Financial Results

Keros reported a net loss of $24.2 million in the first quarter of 2022 as compared to a net loss of $15.9 million in the first quarter of 2021. The increase in net loss for the first quarter was largely due to increased research and development efforts as well as additional infrastructure expenses to support the achievement of Keros’ corporate goals.

Research and development expenses were $18.1 million for the first quarter of 2022 as compared to $11.5 million for the same period in 2021. The increase of $6.6 million was primarily due to additional research and development efforts, manufacturing activities, and personnel expenses to support the advancement of Keros’ pipeline.

General and administrative expenses were $6.0 million for the first quarter of 2022 as compared to $4.3 million for the same period in 2021. The increase of $1.8 million was primarily due to increase in personnel expenses and other external expenses to support Keros’ organizational growth.

Keros’ cash and cash equivalents as of March 31, 2022 was $228.6 million compared to $230.0 million as of December 31, 2021. Keros expects that the cash and cash equivalents it had on hand at March 31, 2022 will fund its operating expenses and capital expenditure requirements into the first quarter of 2024.

On May 5, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, reported that it will share preclinical data at the International Society for Cell & Gene Therapy (ISCT) 2022, being held in San Francisco, CA, May 4-7, 2022 on GDA-301 and GDA-601, two product candidates in the Company’s NAM-enabled genetically modified natural killer (NK) pipeline (Press release, Gamida Cell, MAY 5, 2022, View Source [SID1234613700]).

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"The preclinical data generated from our expanding pipeline of NAM-enabled cell therapies is already showing signs of meaningful potential as a future approach to fighting cancer," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "With evidence of enhanced cytotoxicity demonstrated across hematologic cancers and solid tumors with these diverse, genetically modified NK cell immunotherapy programs, we look forward to continuing our progress toward opening new frontiers in cancer immunotherapy."

GDA-301 is an investigational genetically modified NAM-NK cell therapy candidate aimed at targeting hematologic malignancies and solid tumors. The poster (#501), titled "GDA-301: Engineered NAM-NK Cells via CISH Knockout and Membrane-Bound IL-15 Expression Increases Cytotoxicity Against Malignancies," demonstrated that after six hours of co-culture with a chronic myelogenous leukemia (K562) or multiple myeloma (RPMI) cell line, GDA-301, a combined genetic manipulation of CISH gene editing and the engineered expression of mb IL-15, showed increased cytotoxicity compared with control NAM-NK cells. Additional in vitro assays showed elevation of degranulation marker CD107a, and intracellular proinflammatory cytokines interferon-γ and tumor necrosis factor-α, suggesting increased potency of GDA-301 compared with control. The potency and cytotoxicity data suggest that GDA-301 represents a novel potential immunotherapeutic targeting hematologic malignancies as well as solid tumors.

The poster on GDA-301 was selected for presentation at the conference’s Elevator Pitch Session 2 on Thursday, May 5, 2022 at 6:00 p.m. EST/3:00 p.m. PST – 7:00 p.m. EST/4:00 p.m. PST.

GDA-301 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

GDA-601 is an investigational genetically engineered NAM-NK cell therapy candidate designed to target multiple myeloma (MM) cells. The poster (#517), titled "GDA-601: NAM-NK Cells With CD38 Knockout Expresses Enhanced CD38 Chimeric Antigen Receptor and Targets Multiple Myeloma Cells With Increased Cytotoxicity," showed that in vitro killing assays performed six hours after co-culture of GDA-601 with a MM (RPMI) cell line showed increased cytotoxicity compared with control NAM-NK cells. Fratricide attributable to CD38 antigen was effectively eliminated with GDA-601. There was a significant enhancement of potency against CD38-positive MM cells demonstrated by elevation of the degranulation marker CD107a and intracellular proinflammatory cytokines interferon-γ and tumor necrosis factor-α in vitro. These results suggest that GDA-601 displays superior antitumoral responses against MM cells and represent a promising adoptive cell therapeutic strategy against MM.

Both posters will be presented on Thursday, May 5, 2022 at Poster Session 2, at 5:45 p.m. EST/2:45 p.m. PST – 7:15 p.m. EST/4:15 p.m. PST.

GDA-601 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

For more information, please visit isctglobal.org.

About NAM Technology

Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (Nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

On May 5, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the first quarter ended March 31, 2022 (Press release, Repare Therapeutics, MAY 5, 2022, View Source [SID1234613715]).

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"The first quarter was marked by significant progress in our RP-3500 program, including the comprehensive new dataset from the TRESR trial which was part of the featured oral presentation at the AACR (Free AACR Whitepaper) conference this year, and that the United States Adopted Names (USAN) council has adopted ‘camonsertib’ as the nonproprietary (generic) name in the United States, and the International Nonproprietary Names (INN) council has accepted ‘camonsertib’ as proposed INN for RP-3500," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "The findings continue to demonstrate camonsertib’s promising clinical benefit given as monotherapy in patients with solid tumors with multiple genotypes and potential best-in-class safety and tolerability profile for ATR inhibitors. Beyond ATM, encouraging data in other genotypes suggest further validation of our STEP2 platform to identify other synthetic lethalities as we expand TRESR and develop our pipeline of synthetic lethal candidates. We look forward to providing updates on the potential of camonsertib as monotherapy and initial data of camonsertib in combination with PARP inhibitors or gemcitabine expected in the second half of this year."

First Quarter 2022 Review and Operational Updates:

Announced updated clinical data from the ongoing Phase 1/2 TRESR (Treatment Enabled by SNIPRx) clinical trial of camonsertib, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of solid tumors with specific synthetic-lethal genomic alterations including those in the ATM gene (Ataxia-Telangiectasia mutated kinase) at the 2022 AACR (Free AACR Whitepaper) Annual Meeting.
Updated data showed camonsertib monotherapy continues to appear safe and well tolerated. Expectedly, Grade 1-2 anemia was the most common treatment-related adverse event and was well controlled in patients. Only 24.2% of all patients in the 3 days on 4 days off schedule experienced Grade 3 anemia, and none experienced Grade 4 anemia.

Camonsertib monotherapy resulted in durable clinical benefit across tumor types and genomic alterations. Overall clinical benefit rate (CBR) for all patients was 43%, and 47% in patients after PARP inhibitor (PARPi) failure.

Promising results were observed particularly in patients with advanced ovarian cancer (n = 20). 90% of evaluated patients had prior PARPi failure, and 85% of evaluated patients were platinum resistant. In these patients, overall response (OR) was 25%, including one complete response (CR), three partial responses (PR) as determined by RECIST 1.1 criteria, and one durable and ongoing CA125 response. CBR was 75% and median progression-free survival (mPFS) was 35 weeks.

Clinical benefit was also observed in patients with tumors harboring BRCA1 and BRCA2 genomic alterations, as predicted by SNIPRx. In patients with BRCA1/2 mutated tumors (n = 37), ORR was 14% and included two patients with ovarian cancer, and one each with breast cancer, head and neck squamous cell carcinoma, and melanoma. CBR was 43% with a mPFS of 15 weeks in the BRCA1/2 population; in patients specifically with BRCA1 mutations, the CBR was 48%.

In patients with ATM loss-of-function (LOF) tumors (n = 34), ORR was 9% including one RECIST 1.1 confirmed/unconfirmed response, and two prostate specific antigen (cPSA) responses. CBR in patients with ATM LOF was 44%, with mPFS of 17 weeks.

New sequencing data demonstrated biallelic gene LOF, an emerging biomarker for synthetic lethal therapies, can potentially be leveraged to further enrich for patients most likely to benefit from camonsertib. CBR in patients with biallelic LOF was significantly higher (47%) compared to the CBR in patients with non-biallelic tumors (15%).

A poster presentation, titled "Circulating tumor DNA (ctDNA) determinants of improved outcomes in patients (pts) with advanced solid tumors receiving the ataxia telangiectasia and Rad3-related inhibitor (ATRi), RP-3500, in the phase 1/2a TRESR trial (NCT04497116)" (abstract #367586) will be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual meeting in June.

Announced camonsertib dose selection Phase 1 monotherapy safety data from the Phase 1/2 TRESR Trial at the 2022 ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress
This comprehensive safety analysis from three monotherapy dosing schedules of camonsertib at therapeutic doses confirmed the acceptable tolerability of the recommended phase 2 dose (160mg 3 days on/4 days off).

Anemia was the most common reported toxicity with less than 25% of patients experiencing grade 3 toxicities.

A dose modification plan that includes 2 alternative dosing schedules was established to mitigate the on-target toxicity of anemia and maintain patients on a camonsertib dosing schedule that targets antitumor activity.

A nomogram, based on cycle 1 assessment of toxicities, is being prospectively evaluated to identify patients at increased risk of anemia and inform early intervention.

Announced publication of preclinical data in Nature demonstrating the potential of PKMYT1 inhibitor RP-6306 in tumors with CCNE1 amplification
In April 2022, the Company announced that preclinical data demonstrating inhibition of CCNE1-amplified tumor growth in vivo by selective inhibition of PKMYT1 using RP-6306, a first-in-class small molecule candidate targeting PKMYT1, were published in Nature.

SNIPRx, the Company’s proprietary, genome-wide, CRISPR-based screening approach, was used to uncover CCNE1 amplification as synthetic lethal to PKMYT1 inhibition. Data show PKMYT1 inhibition is a promising therapeutic target in CCNE1-amplified cancers.

Phase 1 clinical trials are currently evaluating RP-6306 as a monotherapy (MYTHIC) as well as in combination with gemcitabine (MAGNETIC) for the treatment of molecularly selected advanced solid tumors. The Company recently initiated an additional Phase 1 (MINOTAUR) clinical trial of RP-6306 in combination with FOLFIRI also for the treatment of molecularly selected advanced solid tumors.

Initiated patient enrollment in a new arm of its Phase 1 MYTHIC clinical trial designed to evaluate the safety and tolerability of RP-6306 in combination with camonsertib in patients with advanced solid tumors.
Appointed Philip Herman to Executive Leadership Team as EVP, Commercial & New Product Development
In January 2022, the Company appointed Philip Herman as EVP, Commercial & New Product Development. Mr. Herman was most recently Chief Commercial Officer of Y-mAbs Therapeutics and led the successful launch of DANYELZA (naxitamab).
First Quarter 2022 Financial Results:

Cash and cash equivalents and marketable securities: Cash and cash equivalents and marketable securities as of March 31, 2022 were $311.7 million.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $26.5 million and $16.5 million for the three months ended March 31, 2022 and 2021, respectively. The year-over-year increase in Net R&D expenses was primarily due to direct external costs related to the Company’s camonsertib and RP-6306 programs, and personnel related expenses, including share-based compensation.
General and administrative (G&A) expenses: G&A expenses were $8.8 million and $5.2 million for three months ended March 31, 2022 and 2021, respectively. The year-over-year increase in G&A expenses was primarily due to personnel related costs, including share-based compensation, as we scale the organization, and professional fees related to the Company’s transition from emerging growth company and smaller reporting company status at the end of 2021.
Net loss: Net loss was $34.8 million, or $0.83 per share in the three months ended March 31, 2022, and $21.4 million, or $0.58 per share in the three months ended March 31, 2021.
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.