On August 26, 2021 Incyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) reported that the European Commission (EC) has granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) (Press release, Incyte, AUG 26, 2021, View Source [SID1234586923]). The EC decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2021 recommending the conditional marketing authorization of Minjuvi.

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"People living with relapsed or refractory DLBCL in the EU, have historically had limited treatment options and a poor prognosis. However, with the EC’s approval of Minjuvi, eligible patients now have a new and much needed treatment option," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We will now focus our efforts on working with individual countries in Europe to provide people access to this new treatment."

"The approval of Minjuvi is a crucial milestone for patients with relapsed or refractory DLBCL in Europe," said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. "DLBCL is the most common type of non-Hodgkin lymphoma in adults and Minjuvi addresses an urgent unmet medical need for the 30-40% of people who do not respond to or relapse, after initial therapy."

The conditional approval is based on the results from the L-MIND study evaluating the safety and efficacy of Minjuvi in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 43.9 months after a minimum follow up of 35 months (secondary endpoint). Minjuvi together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable. Warnings and precautions for Minjuvi include infusion-related reactions, myelosuppression, including neutropenia and thrombocytopenia, infections and tumour lysis syndrome.

"The data from the L-MIND study demonstrate the potential benefits, including long duration of response, that tafasitamab may have for eligible DLBCL patients," said Professor Pier Luigi Zinzani M.D., Ph.D., Head of the Lymphoma Group at University of Bologna. "It is encouraging to see new treatments become available for these patients, especially given the historical lack of treatment options in this area."

Incyte and MorphoSys share global development rights to tafasitamab; Incyte has exclusive commercialization rights to tafasitamab outside the United States. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and is marketed by Incyte under the brand name Minjuvi in the EU.

About Diffuse Large B-Cell Lymphoma
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases4, and is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs5. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter6. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL7,8,9.

About L-MIND
The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy (HDC) or autologous stem cell transplant (ASCT). The study’s primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019.

For more information about L-MIND, visit View Source

About Minjuvi (tafasitamab)
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi(tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in the EU.

XmAb is a registered trademark of Xencor, Inc.

Safety Information from the EU Summary of Product Characteristics (SmPC)
Infusion-related reactions may occur and have been reported more frequently during the first infusion. Patients should be monitored closely throughout the infusion and should be advised to contact their healthcare professionals if they experience signs and symptoms of infusion related reactions including fever, chills, rash or breathing problems within 24 hours of infusion. A premedication should be administered to patients prior to starting tafasitamab infusion. Based on the severity of the infusion-related reaction, tafasitamab infusion should be interrupted or discontinued and appropriate medical management should be instituted.

Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with Minjuvi.

Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops.

Treatment with Minjuvi in combination with lenalidomide should not be initiated in female patients unless pregnancy has been excluded.

The most common adverse reactions were infections, neutropenia, asthenia, anemia, diarrhea, thrombocytopenia, cough, oedema peripheral, pyrexia and decreased appetite.

Minjuvi may cause serious adverse reactions. The most common serious adverse reactions were infection, including pneumonia and febrile neutropenia.

Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia and anemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.

On August, 26, 2021 ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported it had entered into a royalty purchase agreement with HealthCare Royalty Partners (HealthCare Royalty) (Press release, ADC Therapeutics, AUG 26, 2021, View Source [SID1234586940]).

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Under the terms of the $325 million financing agreement, ADC Therapeutics will receive $225 million upon closing, and is eligible to receive an additional $75 million upon the first commercial sale of ZYNLONTATM (loncastuximab tesirine) in Europe and an additional $25 million upon the achievement of a near-term commercial milestone for ZYNLONTA. In exchange, HealthCare Royalty will receive a 7% royalty on worldwide net sales and licensing revenue from ZYNLONTA, with the exception of greater China, Singapore and South Korea, and a 7% royalty on worldwide net sales and licensing revenue from Cami (camidanlumab tesirine) (subject to limited carve-outs). Based on performance tests in 2026 and 2027, these royalty rates are subject to potential upward adjustment, up to a maximum of 10%. The total royalty payable by ADCT to HealthCare Royalty is capped in the range of 2.25x to 2.50x of the amount paid to ADCT, dependent upon the amount of royalties paid by 2029. Once the cap is hit, the agreement terminates. Upon closing of this transaction, and together with the Company’s current cash balance and anticipated business plan, ADC Therapeutics will have a substantial multi-year working capital runway.

"This transaction reflects the significant value of ZYNLONTA and Cami. We are delighted to partner with HealthCare Royalty, a leading healthcare investment firm, to continue the development and commercialization of ZYNLONTA in combination with other drugs, in earlier lines of therapy and in new histologies, as well as to continue our development and commercialization plans for Cami," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "With this transaction, we are well-positioned to continue executing on our plans and improving the lives of patients."

"We are pleased to partner with ADC Therapeutics to reach their vision of developing and commercializing potent and targeted ADCs for patients with hematological malignancies and solid tumors," said Clarke Futch, Chairman and Chief Executive Officer of HealthCare Royalty. "Our investment reflects our belief in both ZYNLONTA and Cami to deliver value, and underscores our mission to facilitate innovation by high growth biopharmaceutical companies globally."

The agreement includes customary provisions for a transaction of this nature, a repayment provision at the Company’s option, and change of control provisions. The Company expects to close the transaction in early September. The Company has concurrently filed a Form 6-K which includes further details.

Morgan Stanley & Co. LLC acted as Sole Structuring Agent and Ropes & Gray LLP and Davis Polk LLP acted as legal advisors to ADC Therapeutics on the transaction. Gibson Dunn LLP acted as legal advisors to HealthCare Royalty.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, evading DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/ triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

On August 26, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported the launch of its wholly-owned subsidiary, Skunkworx Bio, Inc. ("Skunkworx"), focused on the development of a drug discovery paradigm to enable rapid drug development (Press release, Heat Biologics, AUG 26, 2021, View Source [SID1234586963]).

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Skunkworx’s unique, highly diverse, proprietary libraries of "Pocket Biologics" are used to identify miniature proteins which bind to critical domains of druggable targets. The Skunkworx approach aims to enable rapid drug discovery and validation of new innovative therapeutics utilizing advanced computational methods and bioinformatics to further enhance target precision. Skunkworx has successfully identified agonists and antagonists for a number of targets and is in the process of progressing several of these assets through preclinical studies.

Matt Seavey, Ph.D., Skunkworx’s Executive Director of Scientific Operations, commented, "Our unique process flips the paradigm of drug discovery, as it enables us to rapidly identify novel drug targets to determine if a target is druggable. By utilizing this approach, we have been able to identify lead targets and already have several promising programs underway."

Jeff Wolf, Chief Executive Officer of Heat, commented, "We are extremely proud to launch Skunkworx, an innovative platform to accelerate the path from discovery to preclinical development. Skunkworx augments Heat’s emerging drug development ecosystem designed to efficiently move new biologic programs from discovery into the clinic. New programs will be discovered through Skunkworx, developed at Heat and manufactured at Scorpion Biological Services, Heat’s wholly owned manufacturing subsidiary. This integrated platform is focused on driving innovation by rapidly accelerating the drug development process. We look forward to working with Skunkworx to advance a wide repertoire of drugs across a wide variety of indications, including biosecurity applications, an area of growing importance."

On August 26, 2021 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) reported the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) for distribution within Latin America (Press release, BioNTech, AUG 26, 2021, View Source [SID1234586907]).

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Eurofarma will perform manufacturing activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span four continents and include more than 20 manufacturing facilities. To facilitate Eurofarma’s involvement in the process, technical transfer, on-site development, and equipment installation activities will begin immediately. Per the agreement, Eurofarma will obtain drug product from facilities in the U.S., and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production is expected to exceed 100 million finished doses annually. All doses will exclusively be distributed within Latin America.

"Everyone – regardless of financial condition, race, religion or geography – deserves access to lifesaving COVID-19 vaccines," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Our new collaboration with Eurofarma expands our global supply chain network to another region – helping us continue to provide fair and equitable access to our COVID-19 vaccine. We will continue to explore and pursue opportunities such as this to help ensure that vaccines are available to all who are in need."

"We have been continuously increasing the manufacturing capacity of our own facilities and included dozens of manufacturing partners into our global network. Together with Pfizer, we have delivered more than 1.3 billion doses and we plan to deliver 3 billion doses in total by the end of the year. Today’s partnership is an important step to broaden the access to vaccines in Latin America and beyond by expanding our global manufacturing network," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "We will continue to enable people worldwide to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses."

"At such a difficult time as this one, being able to share this news fills us with pride and hope. Eurofarma is about to turn 50 years old and signing this collaboration in the production of the COVID-19 vaccine represents another milestone in our trajectory. We are making available our best resources in terms of industrial capacity, technology and quality to this project, so that we can meet the contract with excellence and contribute to supplying the Latin American market," said Maurízio Billi, President, Eurofarma.

Pfizer and BioNTech select contract manufacturers using a rigorous process based on several factors: quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program.

To date, Pfizer and BioNTech have shipped more than 1.3 billion COVID-19 vaccine doses to more than 120 countries and territories in every region of the world. The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments and global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year. This includes direct supply agreements with individual country governments; an agreement to supply 500 million doses to the U.S. Government at a not-for-profit price, which the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries; and a direct supply agreement with COVAX for 40 million doses in 2021.

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

U.S. Indication & Authorized Use
COMIRNATY (COVID-19 vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
prevent COVID-19 in individuals 12 through 15 years, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The Pfizer-BioNTech COVID-19 vaccine has received EUA from FDA to:

prevent COVID-19 in individuals 12 years of age and older, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The FDA-approved COMIRNATY (COVID-19 vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY (COVID-19 vaccine, mRNA) or the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

EUA Statement
This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Important Safety Information
Individuals should not get the Pfizer-BioNTech COVID-19 vaccine if they:

had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine
Individuals should tell the vaccination provider about all of their medical conditions, including if they:

have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
The vaccine may not protect everyone.

Side effects reported with the vaccine include:

There is a remote chance that the vaccine could cause a severe allergic reaction
A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
chest pain
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported with the vaccine include:
severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); diarrhea; vomiting; arm pain
These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The vaccine is still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away
There is no information on the use of the vaccine with other vaccines.

Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit View Source or call 1‐800‐822‐7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Please click here for full Prescribing Information (16+ years of age). Please click here for Fact Sheet for Vaccination Providers (12+ years of age).

On August 26, 2021 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported financial results for the fiscal quarter ended June 30, 2021, and provided business updates (Press release, Erasca, AUG 26, 2021, View Source [SID1234586925]).

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"This has been a productive time for Erasca that has included significant achievement across our research and development, corporate, and operational initiatives," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "In December 2020, our first compound entered the clinic, marking an exciting milestone for the company and for our ERAS-601 program targeting SHP2 in advanced tumors. We have continued the clinical momentum with initiation of the HERKULES-1 Phase 1b/2 clinical trial in May 2021 for our ERAS-007 ERK1/2 inhibitor and look forward to initiating HERKULES-2 and HERKULES-3 later this year. Together, ERAS-601 and ERAS-007 comprise our first, innovative MAPKlamp, designed to comprehensively shut down upstream and downstream nodes of the RAS/MAPK pathway. In addition, we are excited to have recently nominated our first homegrown development candidate from our in-house discovery research efforts, ERAS-3490, which is a CNS-penetrant KRAS G12C inhibitor. As we look to the second half of the year, the recent closing of our successful $345 million initial public offering supported by top-tier institutional investors positions Erasca well to advance our industry-leading pipeline of 11 programs targeting the RAS/MAPK pathway."

Research and Development (R&D) Highlights

Nominated ERAS-3490 Development Candidate: In June 2021, Erasca nominated ERAS-3490 as its development candidate from its KRAS G12C inhibitor program with high CNS penetration.
Dosed First Patient in HERKULES-1 Study: In May 2021, Erasca dosed the first patient in HERKULES-1, a Phase 1b/2 trial for ERAS-007 (ERK1/2 inhibitor), which will be used alone and in combination with ERAS-601 (SHP2 inhibitor; together, Erasca’s first MAPKlamp) in advanced solid tumors.
Dosed First Patient in FLAGSHP-1 Study: In December 2020, Erasca dosed the first patient in the Phase 1/1b FLAGSHP-1 study evaluating ERAS-601 in patients with advanced solid tumors.
Corporate Highlights

Completed $345 Million Initial Public Offering: In July 2021, Erasca sold 21,562,500 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 2,812,500 additional shares of common stock, at a public offering price of $16 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Erasca, were $345 million.
Expanded Leadership Team: In May 2021, Erasca made key senior appointments in finance, business development, operations, legal, regulatory, manufacturing, clinical pharmacology, and data science.
Appointed Board of Directors: In March 2021, Erasca appointed Bihua Chen and Julie Hambleton, M.D., to its board of directors.
Strengthened Executive Leadership Team: In January 2021, Erasca announced the appointment of Wei Lin, M.D., as Chief Medical Officer and David Chacko, M.D., as Chief Financial Officer. In May 2021, Erasca announced the appointment of Ebun Garner as General Counsel.
Expanded Pipeline: In January 2021, Erasca announced two exclusive, worldwide agreements
ERAS-601, a potential best-in-class inhibitor of the Src homology region 2 domain-containing phosphatase-2 (SHP2), was in-licensed from NiKang Therapeutics, Inc.
ERAS-007, a potential best-in-class inhibitor of the extracellular signal-regulated kinase (ERK), the most distal node of the RAS/MAPK pathway, was acquired from ASN Product Development, Inc., a wholly-owned subsidiary of Asana BioSciences, LLC.
Key Upcoming 2021 Milestones

HERKULES-2: a Phase 1b/2 clinical trial for ERAS-007/MAPKlamp in combination with various agents in patients with non-small cell lung cancer (NSCLC)
Dosing of the first patient expected in third quarter of 2021
HERKULES-3: a Phase 1b/2 clinical trial for ERAS-007/MAPKlamp in combination with various agents in patients with colorectal cancer (CRC)
Dosing of the first patient expected in second half of 2021
Second Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents, and investments were $198.7 million as of June 30, 2021, as compared to $118.7 million as of December 31, 2020. Subsequent to the end of the quarter, Erasca completed an IPO raising net proceeds of $317.7 million, after deducting underwriting discounts, commissions and other offering expenses. Erasca expects its current cash, cash equivalents, and investments balance to fund operations for at least the next 24 months.

R&D Expenses: R&D expenses were $17.6 million for the quarter ended June 30, 2021, compared to $5.9 million for the quarter ended June 30, 2020. The increase was primarily driven by expenses incurred in connection with clinical trials and preclinical studies, personnel costs due to increased headcount to support increased development activities, and outsourced services and consulting fees.

General and Administrative (G&A) Expenses: G&A expenses were $5.1 million for the quarter ended June 30, 2021, compared to $1.4 million for the quarter ended June 30, 2020. The increase was primarily driven by personnel costs, legal fees, and audit fees.

Net Loss: For the quarter ended June 30, 2021, Erasca reported a net loss of $28.2 million, or $(1.20) per basic and diluted share, compared to a net loss of $5.5 million, or $(0.26) per basic and diluted share, for the quarter ended June 30, 2020.