On December 4, 2020 McKesson and Amgen (NASDAQ:AMGN), one of the world’s leading biotechnology companies, reported that have signed a strategic agreement to help improve cancer care in community oncology settings (Press release, Amgen, DEC 4, 2020, View Source [SID1234572177]). Today, 1 in 5 cancer patients receives an Amgen medicine, while McKesson reaches 20% of U.S. cancer patients. This multi-year agreement bridges the power and reach of the two companies and will focus on reducing gaps in care by optimizing access to innovative precision medicine and immuno-oncology in the community setting.

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Access to the latest innovations in cancer care is still very dependent on demographics, socioeconomic status, and where in the U.S. patients receive their care. Currently, the majority of new patients are first seen in the community setting,1 making community oncology practices increasingly critical to improved patient care. Community oncology providers also typically treat a more diverse patient population, providing the greatest opportunity to impact cancer care across dimensions, including rural populations.

"Community oncology practices in the United States are the backbone of oncology care for the vast majority of patients. The COVID-19 pandemic further heightens the need to help strengthen that network as it has become imperative that people be treated closer to home," said Darryl Sleep, M.D., senior vice president, Global Medical and chief medical officer, Amgen. "At Amgen, we believe that cancer patients and those who treat them deserve to have access to the latest innovations in care no matter where they live or practice. Together with McKesson, our ultimate goal is to help community oncologists and their teams have rapid access to the latest innovations and insights to provide the best care possible where patients need it most."

Kirk Kaminsky, president of U.S. Pharmaceutical, McKesson, shared, "The combined commitment of our organizations to optimize patient outcomes will change the future of cancer care. We look forward to working with Amgen and oncology providers to navigate the inherent complexity in cancer and make novel insights actionable and accessible at the exact point of need."

This partnership will be led by OntadaTM, McKesson’s new oncology technology and insights business. Ontada is focused on helping life sciences companies like Amgen improve patient outcomes for cancer care, from early clinical development to drug commercialization and post-launch activation of insights, as well as empowering oncology providers at the point of need to deliver more-informed, more-effective, more-efficient care to their patients. Through real-world data gathered with Ontada’s proprietary technology for community oncology practices, such as those that are part of The US Oncology Network, Ontada has the real-world knowledge to help push cancer care forward.

"I have been an oncologist for 30 years, and we have never seen so much innovation, yet so many challenges, as we do today," said Michael Seiden, MD, PhD, president, The US Oncology Network. "Being able to contribute to such robust thought leadership and work with stakeholders like Ontada and Amgen allow us to really move the needle and enhance cancer care for the patients we serve in the community setting."

Amgen and Ontada will launch various programs over the course of the partnership and build on projects that have already begun, such as those focusing on reducing gaps in molecular testing and understanding treatment patterns in the community setting. For example, Amgen and McKesson recently conducted real-world research to better understand patterns of molecular testing in advanced/metastatic non-small cell lung cancer with community oncologists with plans to publish the findings in early 2021. Through the strategic partnership, McKesson and Amgen hope to:

Elevate awareness on molecular testing in order to optimize care in patients that benefit from targeted therapy;
Uncover insights on unmet need and treatment outcomes by enriching data and insight capabilities;
Leverage real-world evidence to better understand and optimize the deployment of biosimilars to offer providers and their patients greater choice of therapies relative to value;
Co-develop new approaches to deliver immuno-oncology therapies in the community setting; and
Optimize therapy sequencing to improve patient outcomes including supportive care.

On December 4, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of a clinical use study demonstrating that management decisions for patients diagnosed with American Joint Committee on Cancer (AJCC) 7th edition stage I – III melanoma were impacted by the use of DecisionDx-Melanoma, Castle’s gene expression profile prognostic test for cutaneous melanoma (Press release, Castle Biosciences, DEC 4, 2020, View Source [SID1234572175]). Study authors developed a recommended melanoma patient care management pathway that incorporates DecisionDx-Melanoma to help inform frequency and duration of follow-up visits, blood work and surveillance imaging in line with predicted metastatic risk.

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The article, titled "Integrating the melanoma 31-gene expression profile test to surgical oncology practice within national guideline and staging recommendations," was published in Future Oncology.

"We found that intrinsic tumor biology, as assessed with DecisionDx-Melanoma, adds prognostic information that might be missed if we solely consider traditional risk factors to predict metastatic risk for our patients with stage I – III melanoma," said the article’s first author, surgical oncologist David Hyams, M.D. "Based on these results, we propose a melanoma patient care plan that incorporates DecisionDx-Melanoma to adjust frequency and duration of clinical visits, blood work and surveillance imaging according to metastatic risk. We expect that this plan will empower physicians to focus more intensive surveillance on high-risk patients who need it most."

The study was conducted to characterize changes in clinical management resulting from use of DecisionDx-Melanoma on low (stage I–IIA) and high-risk (stage IIB–III) patient management and to develop a management pathway for melanoma patient care that incorporates DecisionDx-Melanoma test results. A total of 112 consecutive patients with cutaneous melanoma at Desert Surgical Oncology in California between 2015–2017 were included in this study, all of whom were prospectively tested with DecisionDx-Melanoma.

Patients’ DecisionDx-Melanoma test results were found to have an impact on the number and duration of follow-up and surveillance visits, and patients assessed as having a high risk of metastasis (designated by a DecisionDx-Melanoma Class 2 test result) received more intensive management than patients assessed as having a low risk (designated by a DecisionDx-Melanoma Class 1 test result). Clinicians using the test were shown to adjust patient management in a risk-appropriate direction, within recommendations of national guidelines.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through September 30, 2020, DecisionDx-Melanoma has been ordered more than 64,560 times for use in patients with cutaneous melanoma.

On December 4, 2020 Cogent Biosciences, Inc. ("Cogent") (NASDAQ: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the closing of its upsized underwritten public offering of 11,794,872 shares of its common stock at a public offering price of $9.75 per share (Press release, Cogent Biosciences, DEC 4, 2020, View Source [SID1234572174]). This includes the exercise in full by the underwriters of their 30-day option to purchase up to 1,538,461 additional shares of common stock. The aggregate proceeds to Cogent from the offering, after deducting the underwriting discounts and commissions and before estimated offering expenses, were approximately $108.1 million.

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The net proceeds from the offering will be used for the continued development, regulatory and commercial preparation of PLX9486 to treat patients living with systemic mastocytosis and gastrointestinal stromal tumors (GIST).

Jefferies and Piper Sandler & Co. acted as joint book-running managers for the offering. Wedbush PacGrow, LifeSci Capital and Ladenburg Thalmann also acted as co-managers for the offering.

The shares of common stock described above were offered by Cogent Biosciences, Inc. pursuant to a registration statement previously filed with the Securities and Exchange Commission (the "SEC") that became effective on May 1, 2019. A final prospectus supplement and accompanying prospectus were filed with the SEC and available for free on the SEC’s website at View Source Registration statements relating to the securities were filed with, and declared effective by, the Securities and Exchange Commission (the "SEC") and became effective on May 1, 2019. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus supplement and accompanying base prospectus. Copies of the final prospectus relating to the offering may be obtained from the SEC’s website at www.sec.gov or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]): or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicolett Mall, J12SO3, Minneapolis Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 4, 2020, Sorrento Therapeutics, Inc. (the "Company") reported that it entered into Amendment No. 1 (the "Amendment") to that certain Sales Agreement, dated April 27, 2020 (the "Sales Agreement"), by and between the Company and A.G.P./Alliance Global Partners (the "Agent") (Filing, 8-K, Sorrento Therapeutics, DEC 4, 2020, View Source [SID1234572173]).

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The Sales Agreement provides that the Company could offer and sell, from time to time, through or to the Agent, as sales agent and/or principal, up to $250,000,000 in shares of its common stock (the "Shares"), with the Shares to be issued pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-237142) filed with the Securities and Exchange Commission (the "SEC") on March 13, 2020 and declared effective on March 20, 2020 (the "Form S-3"), the base prospectus dated March 20, 2020 included in the Form S-3 and the prospectus supplement, dated April 27, 2020. As of December 4, 2020, the Company has sold an aggregate of 29,543,092 Shares for gross proceeds of approximately $222.8 million, leaving an aggregate of approximately $27.2 million in Shares available for issuance under the Sales Agreement.

The Amendment amends the Sales Agreement to provide that the Company may offer and sell, from time to time, through or to the Agent, as sales agent and/or principal, up to an additional $450,000,000 in shares of the Company’s common stock (the "Additional Shares"), such that the Company may offer and sell up to an aggregate of $700,000,000 in shares of its common stock (the "Offering") pursuant to the Sales Agreement, as amended by the Amendment (the "Amended Sales Agreement"). Any Additional Shares offered and sold in the Offering will be issued pursuant to the Form S-3, the base prospectus dated March 20, 2020 included in the Form S-3 and the prospectus supplement, dated December 4, 2020, that will be filed with the SEC.

Subject to the terms and conditions of the Amended Sales Agreement, the Agent will use its commercially reasonable efforts to sell the shares of the Company’s common stock from time to time, based upon the Company’s instructions. Under the Amended Sales Agreement, the Agent may sell the shares of the Company’s common stock by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

The Company has no obligation to sell any shares of its common stock pursuant to the Amended Sales Agreement, and may at any time suspend offers under the Amended Sales Agreement. The Offering will terminate upon (i) the election of the Agent upon the occurrence of certain adverse events, (ii) three business days’ advance notice from one party to the other, or (iii) the sale of all $700,000,000 of shares of the Company’s common stock pursuant thereto.

Under the terms of the Amended Sales Agreement, the Agent will be entitled to a commission at a fixed rate of 3.0% of the gross proceeds from each sale of shares of the Company’s common stock under the Amended Sales Agreement.

The Company currently intends to use any additional net proceeds from the Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, regulatory affairs expenditures, clinical trial expenditures, acquisitions of new technologies and investments, business combinations and the repayment, refinancing, redemption or repurchase of indebtedness or capital stock. The Company may use a portion of the net proceeds to repurchase or redeem those certain senior secured notes due 2026 in an initial aggregate principal amount of $224,000,000 issued by Scilex Pharmaceuticals Inc., an indirect majority-owned subsidiary of the Company, in September 2018.

The foregoing description of the Sales Agreement and the Amendment does not purport to be complete and is qualified in its entirety by reference to: (i) the full text of the Sales Agreement, a copy of which was filed as Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on April 27, 2020, and (ii) the full text of the Amendment, which is filed as Exhibit 1.1 hereto, each of which is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of any securities in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

On December 4, 2020 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a company pioneering the discovery and development of a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Foghorn Therapeutics, DEC 4, 2020, View Source [SID1234572172]).

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"This is an eventful period for Foghorn as the company is on the cusp of transitioning our first two compounds into clinical studies," said Adrian Gottschalk, CEO of Foghorn. "We expect our first IND for FHD-286 to be submitted before the end of this year. In addition, our first degrader program, FHD-609, remains on track for an IND filing in the first half of next year. We have raised $240 million this year through a private financing round, subsequent IPO and our Merck collaboration, positioning the company to advance our broad pipeline targeting the chromatin regulatory system."

Recent Corporate Highlights

Completed $135 Million Initial Public Offering: In October 2020, Foghorn sold 7,500,000 shares of common stock at a public offering price of $16 per share. In November 2020, the underwriters exercised their option to purchase an additional 951,837 shares of common stock at the public offering price. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Foghorn, were $135.2 million.

Entered into collaboration agreement with Merck to discover and develop novel oncology therapeutics against a transcription factor target: Under the terms of the agreement, signed in July 2020, Foghorn received a $15 million upfront payment and is eligible to receive up to an additional $410 million in development, regulatory and commercial milestones as well as royalties on product sales if products are successfully developed and commercialized under the collaboration.

Strengthened management team: In November 2020, Foghorn appointed Michael LaCascia as Chief Legal Officer.
Key Upcoming Milestones

FHD-286 IND submission expected by year end 2020: FHD-286, a highly potent, selective, allosteric, orally available small molecule enzymatic inhibitor is initially being developed in acute myelogenous leukemia and uveal melanoma. The company remains on track to submit an Investigational New Drug (IND) to the FDA by year end.

FHD-609 IND submission expected in the first half of 2021: FHD-609, a highly potent, selective, intravenous, small molecule protein degrader of BRD9 is initially being developed for the treatment of synovial sarcoma with the intention to expand into indications beyond synovial sarcoma, including SMARCB1-deleted tumors. The company remains on track to file an IND with the FDA in the first half of 2021.
Third Quarter 2020 Financial Results

Cash Position and Financial Guidance: Cash and cash equivalents as of September 30, 2020 were $74.6 million, compared to $15.0 million as of December 31, 2019. The September 30, 2020 cash and equivalents excludes $122.2 million in net proceeds from our initial public offering, which was completed in October 2020.

Revenues: Collaboration revenues for the third quarter of 2020 were $0.2 million, compared to no revenue for the third quarter of 2019, which reflects revenue recognized under our research collaboration agreement with Merck which was entered into in July 2020.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2020 were $16.1 million, compared to $11.3 million for the third quarter of 2019. The increase in R&D expenses was primarily attributable to higher preclinical costs related to our first two programs and increased personnel to support our research and development activities.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2020 were $2.6 million, compared to $1.8 million for the third quarter of 2019. The increase in G&A expenses was primarily attributable to an increase in headcount in our general and administrative functions to support our business.

Net Loss: Net loss attributable to common stockholders was $18.4 million, or $3.12 per share, for the quarter ended September 30, 2020, compared to $13.1 million, or $3.05 per share, for the quarter ended September 30, 2019.