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.

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 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that management will participate in the following upcoming investor conferences (Press release, Aclaris Therapeutics, AUG 26, 2021, View Source [SID1234586922]):

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H.C. Wainwright 23rd Annual Global Investment Conference. On Monday, September 13, 2021 at 7:00 a.m. ET, Dr. Neal Walker, the President and CEO of Aclaris, will virtually present a company overview. Management will be available September 13th throughout the day for virtual one-on-one meetings.

2021 Cantor Virtual Global Healthcare Conference. On Monday, September 27, 2021 at 9:20 a.m. ET, Dr. Walker will participate in a virtual fireside chat. Management will be available September 27th throughout the day for virtual one-on-one meetings.
A live webcast of the presentation and fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. Each webcast will be archived for at least 30 days on the Aclaris website.

On August 26, 2021 Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) (the "Company"), a gene-editing platform company with clinical-stage immuno-oncology programs using allogeneic chimeric antigen receptor (CAR)-T cells and gene therapy programs for monogenic diseases, reported that management plans to participate in five virtual investor conferences (Press release, Cellectis, AUG 26, 2021, View Source [SID1234586921]).

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11th Annual Biotech Symposium (Goldman Sachs)

Date: Tuesday, September 7, 2021

Time: 8AM-6PM (GMT)

Citi’s 16th Annual Biopharma Conference 2021
Date: Thursday, September 9, 2021

Time: 10:40AM ET

Wells Fargo Healthcare Conference

Date: Friday, September 10, 2021

Time: 9:20AM ET

H.C. Wainwright 23rd Annual Global Investment Conference

Date: Monday, September 13, 2021

Time: 7AM ET

Baird 2021 Global Healthcare Conference

Date: Wednesday, September 15, 2021

Time: 9:05 AM ET

Live webcasts of these events and a replay of these webcasts will be available under the "Events and Webcasts" section on the Investor page of the of the Company’s at website: View Source

On August 26, 2021 Aadi Bioscience, Inc. ("Aadi") (Nasdaq: AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported the closing of its previously announced merger with Aerpio Pharmaceuticals, Inc. (previously traded on the Nasdaq Capital Market under "ARPO") (Press release, Aadi Bioscience, AUG 26, 2021, View Source [SID1234586920]).

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The combined, publicly traded company will focus on the advancement, expansion and commercialization of Aadi’s clinical stage pipeline, including Aadi’s lead program for its nanoparticle albumin-bound mTOR inhibitor, FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009), an mTOR inhibitor bound to human albumin. Shares of the combined company, which is operating under the name Aadi Bioscience, Inc. will commence trading on the Nasdaq Global Select Market under the ticker symbol "AADI" on August 27, 2021.

Neil Desai, Ph.D., Chief Executive Officer of the new combined company, stated, "Today’s news represents an important inflection point for Aadi and the development of FYARRO. The completion of the merger, and now becoming a public entity, allows us to take the next step toward commercialization of our pipeline. As we approach our PDUFA date for FYARRO for the treatment of patients with PEComa and prepare to initiate a registrational trial in patients with tumors harboring TSC1 and TSC2 inactivating alterations by year-end, we believe that we are optimally positioned, and look forward to advancing FYARRO to help patients with genetically-driven cancers."

Aadi’s registration trial of FYARRO in advanced malignant PEComa (the AMPECT trial) demonstrated meaningful clinical efficacy in malignant PEComa1, a type of cancer with the highest known alteration rate of TSC1 or TSC2 genes. FYARRO has received Breakthrough Therapy, Fast-Track and Orphan Designations from the U.S. Food and Drug Administration (FDA). A rolling New Drug Application (NDA) submission was completed in May 2021 for this indication and the FDA accepted the NDA in July 2021 and granted Aadi Priority Review status with a Prescription Drug User Fee Act (PDUFA) target action date of November 26, 2021.

About the Merger and Concurrent PIPE Financing

Concurrent to the closing of the merger, the combined company also closed the previously announced $155 million Private Investment in Public Equity (PIPE) financing of its common stock. The PIPE Financing was led by Acuta Capital Partners and KVP Capital and included Avoro Capital Advisors; Avoro Ventures; Venrock Healthcare Capital Partners; BVF Partners, L.P.; Vivo Capital; Alta Bioequities, L.P.; Rock Springs Capital; RTW Investments, LP; Acorn Bioventures; and Serrado Capital LLC as well as other undisclosed institutional investors. Proceeds from the PIPE financing are expected to be used for the commercialization of FYARRO in advanced malignant PEComa, a planned tumor-agnostic registrational trial in solid tumors harboring inactivating alterations in the mTOR pathway genes TSC1 and TSC2 expected to be initiated by the end of 2021 and ongoing studies and general operating expenses.

Effective as of the merger close, Aadi has approximately $170 million in cash and cash equivalents and an expected runway into 2024.

On August 26, 2021, and in connection with the closing of the merger, Aerpio effected a 1-for-15 reverse stock split. All issued and outstanding shares of common stock of Aerpio were subject to the reverse stock split. Upon completion of the merger, taking into consideration the reverse stock split and the exchange ratio, the combined company has approximately 20.8 million shares of common stock outstanding with pre-merger Aadi stockholders collectively owning or holding rights to acquire approximately 29.2% of the combined company, on a fully-diluted basis, pre-merger Aerpio stockholders collectively owning or holding rights to acquire approximately 15.2% of the combined company, on a fully-diluted basis, and the PIPE Investors collectively owning approximately 55.6% of the combined company, on a fully-diluted basis.

Immediately prior to the effective time of the merger, Aerpio distributed a non-transferable contingent value right (a "CVR") to Aerpio shareholders that became effective immediately prior to the time of the merger, entitling CVR holders to receive net proceeds received by Aerpio, if any, associated with Aerpio’s legacy assets. The terms and conditions of the CVRs are pursuant to a CVR Agreement entered into prior to the closing the merger. The CVRs are not transferable, except in certain limited circumstances as provided in the CVR Agreement, are not certificated or evidenced by any instrument and are not registered with the Securities and Exchange Commission (the "SEC") or listed for trading on any exchange.

Additional information about the transaction will be provided in a Current Report on Form 8-K that will be filed by Aadi with the SEC and will be available at View Source

Jefferies LLC; Cowen and Company, LLC; and Piper Sandler & Co. served as placement agents in the private placement. Perella Weinberg Partners LP and Piper Sandler & Co. served as financial advisors to Aadi for the transaction and Wilson Sonsini Goodrich & Rosati, P.C. served as legal counsel to Aadi. Ladenburg Thalmann & Co. Inc. acted as financial advisor to Aerpio for the transaction and Goodwin Procter LLP served as legal counsel to Aerpio.

Management and Organization

Neil Desai, Ph.D., President and Chief Executive Officer and Director of Aadi will continue to lead the combined company along with the Aadi management team following this transaction. In addition to Dr. Desai, the Board of Directors will include pre-merger Aadi Board member Rick Maroun, General Counsel & Partner, Legal and Operations at Frazier Healthcare Partners. In addition, Lance Thibault, Managing Director at Danforth Advisors, LLC ("Danforth"), was appointed as interim Chief Financial Officer of the combined company. Mr. Thibault has over 30 years of experience as a life science CFO and senior executive.

Upon the closing of the merger, Caley Castelein, M.D. and Anupam Dalal, M.D., former members of the Aerpio Board of Directors, will continue on the combined company’s Board of Directors.

Also concurrent with the closing of the merger, Aadi’s pre-merger board observer, Karin Hehenberger M.D., Ph.D., has been appointed to the combined company’s board. Dr. Hehenberger brings extensive industry knowledge and medical and life sciences expertise to the combined company’s Board. Dr. Hehenberger currently serves as Chief Executive Officer of Lyfebulb, Inc., a patient engagement platform, and previously served in various roles for Coronado Biosciences, Inc. (now Fortress Biotech, Inc.), including Senior Vice President of Scientific Affairs and, most recently, Chief Medical Officer, and several management positions, including as Vice President, Metabolics Strategy and Business Development, at Johnson & Johnson.

In addition, Behzad Aghazadeh, Ph.D. has been appointed to the combined company’s board. Dr. Aghazadeh brings more than 20 years of experience in the biopharmaceutical industry, including more than 15 years as an institutional investor and previously six years at Booz Allen as a general management consultant to senior executive teams in the healthcare sector. Dr. Aghazadeh currently is the Managing Partner and Portfolio Manager of Avoro Capital Advisors, a global life sciences investment firm with a focus on supporting emerging biotechnology companies. He previously served as Executive Chairman of the Board of Directors of Immunomedics, Inc., a publicly traded biopharmaceutical company (now a subsidiary of Gilead Sciences, Inc.).