On December 15, 2021, Syndax Pharmaceuticals, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with Goldman Sachs & Co. LLC and Cowen and Company LLC (the "Representatives"), as representatives of the several underwriters (collectively, the "Underwriters"), relating to the issuance and sale of (i) 3,157,144 shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), at a price to the public of $17.50 per share, and (ii) pre-funded warrants of the Company to purchase 1,142,856 shares of Common Stock at an exercise price equal to $0.0001 per share (the "Pre-Funded Warrants"), at a price to the public of $17.4999 per share of Common Stock underlying the Pre-Funded Warrants (equal to the public offering price per share of Common Stock, minus the exercise price of each Pre-Funded Warrant) (the "Offering") (Filing, 8-K, Syndax, DEC 15, 2021, View Source [SID1234597376]). In addition, the Company has granted to the Underwriters an option to purchase up to an additional 645,000 shares of Common Stock. The gross proceeds to the Company from the Offering are expected to be approximately $75.3 million (or approximately $86.5 million if the Underwriters exercise their option to purchase additional shares in full).

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The Pre-Funded Warrants are exercisable at any time, provided that each Pre-Funded Warrant holder will be prohibited from exercising such Pre-Funded Warrants into shares of Common Stock if, as a result of such exercise, the holder, together with its affiliates, would own more than 9.99% of the total number of shares of Common Stock then-issued and outstanding, which percentage may change at the holders’ election provided that such limitation cannot exceed 19.99%, and provided that any increase in the beneficial ownership limitation shall not be effective until 61 days after such notice is delivered.

The Offering is being made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-254661), which became effective upon filing with the Securities and Exchange Commission on March 24, 2021, a base prospectus dated March 24, 2021 and the related prospectus supplement dated December 15, 2021. The Offering is expected to close on or about December 20, 2021, subject to satisfaction of customary closing conditions.

The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties, covenants and agreements contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. All of the Company’s directors and executive officers and certain stockholders have agreed, subject to certain exceptions, not to sell or transfer any shares of Common Stock for 90 days, and the Company has agreed not to sell or transfer any shares of the Common Stock for 90 days, in each case, after December 15, 2021, without first obtaining the written consent of the Representatives.

The foregoing description of the terms of each of the Underwriting Agreement and Pre-Funded Warrants does not purport to be complete and is each qualified in its entirety by reference to the Underwriting Agreement and Form of Pre-Funded Warrant, respectively, which are attached as Exhibit 1.1 and Exhibit 4.1 hereto, respectively, and incorporated by reference herein.

On December 15, 2021 Eli Lilly and Company (NYSE: LLY) reported that extensive updates across its research and development (R&D) programs to highlight the company’s strong pipeline and potential for future growth (Press release, Eli Lilly, DEC 15, 2021, View Source [SID1234597192]). At an investment community meeting today, the company is sharing key information across its four therapeutic areas – including pipeline updates and future R&D investments – along with 2022 financial guidance and updated 2021 guidance.

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The company is on track to meet its goal of launching 20 new medicines over the 10-year period from 2014 to 2023. Over the last eight years, Lilly has delivered 16 new medicines and plans to launch five more medicines over the next two years, if approved, including tirzepatide, donanemab, pirtobrutinib, lebrikizumab and mirikizumab. These potential launches contribute to the company’s expectations for top-tier, volume-driven growth over the next decade, as the number of people that can benefit from Lilly’s innovative new medicines continues to increase.

"Lilly’s accomplishments in recent years are impressive, but it’s where we are going that most excites us. We’ve driven results over the last four years, successfully launched new medicines, and invested in high-impact R&D that has set us up for a truly exciting new era," said David A. Ricks, Lilly’s chairman and CEO. "Bringing new practice-changing medicines to patients is our top priority. We have a remarkable opportunity ahead of us to make life better for millions more people around the world."

The company is providing details on its diabetes and obesity, immunology, oncology and neuroscience R&D programs, sharing a number of new pipeline updates and previously undisclosed data. Lilly also will provide insight into its ongoing R&D investments that reflect the company’s conviction around key emerging trends in biopharma innovation.

"I’m very optimistic about the future for Lilly and the patients we serve. In addition to our promising late-stage pipeline, our labs are making new discoveries to bring life-changing medicines to patients who need them," said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. "Lilly has significantly improved our development speed and clinical success rates and will continue to apply this focus as we work to maximize the impact of our existing medicines and create new ones.

"Genetic medicines, including modalities such as RNA therapeutics and viral-delivered gene therapies, are poised to contribute to the next generation of breakthrough treatments for a wide array of diseases," Skovronsky continued. "Today, Lilly will share more about our new capabilities and increased investment in this space, along with new preclinical and clinical data for genetic medicines in our neuroscience and cardiovascular disease research portfolios."

Diabetes and Obesity

Building on its historic foundation of helping people with diabetes, Lilly is expanding its strategic focus to breakthrough medications that disrupt the disease cascade caused by obesity and type 2 diabetes progression, highlighted by tirzepatide and supported by several early-phase incretin assets.

2

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Lilly’s New Drug Application and Marketing Authorization Application, respectively, for tirzepatide for the treatment of adults with type 2 diabetes. Lilly also submitted tirzepatide to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and in six additional markets. Lilly plans to initiate additional tirzepatide studies that include phase 3 studies in obesity related outcomes and obstructive sleep apnea, as well as a phase 2 mechanism of action study in kidney disease.

Lilly is disclosing new data from several assets in its robust early-phase incretin platform focused on obesity. The company’s incretin platform is focused on delivering therapeutics with bariatric surgery-like weight loss with related metabolic benefits and developing convenient, easy-to-use oral incretins.

As it has for nearly 100 years, Lilly continues to work to transform diabetes care through insulin innovation. Lilly’s novel weekly insulin is on track to progress to phase 3 studies in 2022, and the company is advancing a new generation of insulin medicines with its pre-clinical efforts in glucose-sensing insulin.

Immunology

Over the last decade, Lilly has established a presence in immunology, with Taltz and Olumiant addressing patient needs across dermatology and rheumatology. Positive late-stage readouts in 2021 for mirikizumab in moderate-to-severely active ulcerative colitis and lebrikizumab in moderate-to-severe atopic dermatitis provide the potential to help even more patients suffering from disease.

In addition, Lilly has built a deep early-and mid-stage portfolio of novel immunology opportunities that represent potential first-in-class or best-in-class assets from both internal and external innovation. Lilly is sharing new data from several of these molecules, including proof of concept phase 1b atopic dermatitis data for its IL-2 conjugate, in collaboration with Nektar Therapeutics, and is announcing plans to move into additional phase 2 studies.

Oncology

Propelled by the acquisition of Loxo Oncology, Lilly has established a renewed presence in oncology, with a portfolio focused on high-conviction assets. The company’s oncology portfolio, including Verzenio, Retevmo and pirtobrutinib, has the potential to deliver meaningful growth over the course of the decade.

3

Lilly initiated a rolling submission to the FDA for pirtobrutinib, seeking accelerated approval in mantle cell lymphoma, with expectations to complete the submission in 2022 and regulatory action anticipated in early 2023. Lilly continues to invest to maximize the potential of Verzenio for patients, and intends to initiate a phase 3 study to evaluate earlier treatment of prostate cancer in mid-2022.

The company also is providing an overview of several promising early-phase and pre-clinical programs that are expected to deliver new data and potential new trials starting in 2022.

Neuroscience

Lilly is an established leader in neuroscience with a more than 30-year commitment to advancing Alzheimer’s disease research. The company is focused on its work to slow, then halt and eventually prevent age-related neurodegeneration in the decades ahead.

Lilly is providing new biomarker data from donanemab from the phase 2 TRAILBLAZER-ALZ study. Lilly initiated a rolling submission for donanemab to the FDA for accelerated approval in early Alzheimer’s disease, which it expects to complete in the coming months, likely by the end of the first quarter.

The company is also sharing phase 1 data from its next-generation amyloid-lowering antibody, N3PG-IV, noting plans to move this antibody into pivotal trials in 2022. The company has a number of early phase and pre-clinical programs for Alzheimer’s and other neurodegenerative diseases with novel targets and new modalities and is highlighting the significant growth in its early pain pipeline.

Strong Financial Outlook Fueled by New Innovative Medicines

"We believe the continued uptake of our key growth products – which we expect will account for more than two-thirds of core business revenue in 2022 – coupled with our anticipated upcoming launches will allow Lilly to deliver top-tier, volume-driven revenue growth through at least 2030," said Anat Ashkenazi, Lilly senior vice president and chief financial officer. "Lilly remains committed to prioritizing long-term growth, as we maintain significant investment in our exciting pipeline, fund new launches to ensure we can reach more patients in the coming years and continue to expand operating margin."

Updated 2021 Financial Guidance

The company has updated certain elements of its 2021 financial guidance on both a reported and non-GAAP basis. Earnings per share for 2021 are now expected to be in the range of $6.18 to $6.23 on a reported basis and $8.15 to $8.20 on a non-GAAP basis. The company’s 2021 financial guidance reflects adjustments shown in the reconciliation table below.

Numbers may not add due to rounding

(a)includes costs related to business development transactions with Foghorn Therapeutics Inc., Rigel Pharmaceuticals, Inc., Precision Biosciences, Inc., Protomer Technologies Inc., Kumquat Biosciences Inc., Merus N.V., Lycia Therapeutics Inc., Regor Therapeutics Group, ProQR Therapeutics N.V., MiNA Therapeutics Limited, and Asahi Kasei Pharma Corporation.

(b)updated to include additional asset impairment primarily related to a contract-based intangible asset recognized as a result of our acquisition of Loxo Oncology. This impairment is a result of a decision by Bayer to discontinue the development of a phase 1 molecule related to our contact-based intangible asset.

Revenue for 2021 is now expected to be in the range of $28.0 billion to $28.3 billion, reflecting additional revenue from COVID-19 antibodies associated with the recent purchase agreement with the U.S. Government and the channel impact of the updated 2022 NRDL formulary in China. Estimated revenue from COVID-19 antibodies is now expected to be approximately $2.1 billion.

Gross margin as a percent of revenue is still expected to be approximately 75 percent on a reported basis and is now expected to be approximately 78 percent on a non-GAAP basis.

Marketing, selling and administrative expenses are still expected to be in the range of $6.2 billion to $6.4 billion. Research and development expenses are still expected to be in the range of $6.9 billion to $7.1 billion.

Operating margin, defined as operating income as a percent of revenue, is now expected to be approximately 23 percent on a reported basis and still expected to be approximately 30 percent on a non-GAAP basis.

Other income (expense) is still expected to be expense in the range of $250 million to $150 million on a reported basis and is still expected to be expense in the range of $100 million to $0 on a non-GAAP basis. The estimate on a reported basis does not reflect fourth quarter mark-to-market activity for equity investments.

The 2021 effective tax rate is still expected to be approximately 11 percent on a reported basis and approximately 13 percent on a non-GAAP basis.

The following table summarizes the company’s updated 2021 financial guidance.

2022 Financial Guidance

Earnings per share for 2022 are expected to be in the range of $8.00 to $8.15 on a reported basis and $8.50 to $8.65 on a non-GAAP basis.

The company anticipates 2022 revenue between $27.8 billion and $28.3 billion. Revenue growth is expected to be driven by volume growth from key products including Trulicity, Verzenio, Taltz, Jardiance, Cyramza, Emgality, Tyvyt, Retevmo and Olumiant. This growth is expected to be partially offset by lower revenue for Alimta due to its loss of patent exclusivity, and significantly lower anticipated COVID-19 antibody revenue.

Gross margin as a percent of revenue is expected to be approximately 78 percent on a reported basis and 80 percent on a non-GAAP basis.

Marketing, selling and administrative expenses are expected to be in the range of $6.4 billion to $6.6 billion. Research and development expenses are expected to be in the range of $7.0 billion to $7.2 billion.

Operating margin for 2022 is expected to be approximately 30 percent on a reported basis and approximately 32 percent on a non-GAAP basis.

Other income (expense) is expected to be expense between $100 million and $0 on both a reported basis and on a non-GAAP basis.

The 2022 effective tax rate is expected to be approximately 13 to 14 percent on both a reported basis and non-GAAP basis, assuming no significant changes to U.S. tax policy.

Webcast of Conference Call and Investor Materials

As previously announced, investors and the general public can access a live webcast of the Investment Community Meeting, including a presentation of the company’s 2022 and updated 2021 guidance, through a link on Lilly’s website at www.lilly.com. The conference call will begin at 9 a.m. Eastern time today and will be available for replay via the website.

On December 15, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that clinical experience for naxitamab and data from the Company’s SADA technology programs will be presented at the Company’s R&D event, which will take place virtually today at 12 p.m. Eastern Time (Press release, Y-mAbs Therapeutics, DEC 15, 2021, View Source [SID1234597223]).

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Investors, analysts, members of the media and public may access the event via a live webcast.

The Y-mAbs research and development day will feature presentations from oncology key opinion leaders ("KOLs") Javier E. Oesterheld, M.D. (Atrium Health) and Jaume Mora, M.D., Ph.D. (SJD Barcelona Children’s Hospital). An update on Y-mAbs’ broad and advanced product pipeline, including the Company’s SADA Technology, will follow from Vignesh Rajah, MBBS, DCH, MRCP(UK), MBA, (SVP, Chief Medical Officer at Y-mAbs) and Steen Lisby, M.D., DMSc, (SVP, Chief Scientific Officer at Y-mAbs).

SADA Technology

Dr. Lisby will present new details on the proposed mechanism of action for the SADA Technology. The Company plans to file an Investigational New Drug Application ("IND") with the US Food & Drug Administration ("FDA") for GD2-SADA by the end of this year.

Naxitamab

Dr. Mora, who has experience treating neuroblastoma patients with both naxitamab and a competing anti-GD2 antibody, will present compassionate use data regarding an investigational infusion protocol for naxitamab, systematically increasing the infusion rate during the treatment. Using the revised infusion rate, for which a provisional patent application has been filed by Y-mAbs and the co-inventors Jaume Mora from SJD Barcelona Children’s Hospital and Dr. Nai-Kong Cheung, MD, PhD, and Shakeel Modak, MD, both from Memorial Sloan Kettering Cancer Center ("MSK") in New York, it was observed that the protocol may help with managing Grade 3 and Grade 4 adverse events.

DANYELZA (naxitamab-gqgk)

Dr. Oesterheld will present his personal experience from Levine Children’s Hospital after several patient treatment experiences with DANYELZA (naxitamab-gqgk).

"I am delighted to see that the efforts led by Dr. Mora and supported by Y-mAbs as well as Dr. Cheung and Dr. Modak from MSK has led to what we believe may be a significant discovery. After years of experience in the clinic, we believe that Dr. Mora’s method of managing the infusion rate of naxitamab now potentially may open up the use of naxitamab for a wide range of GD2 positive indications, such as breast cancer, melanoma, sarcomas, small-cell lung cancer and other cancers, for which we can now consider planning Phase 2 studies," said Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer further notes, "We are excited to share these new updates on both our naxitamab program and the SADA Technology. We believe that the prospects for the SADA Technology which combines antibodies and radioactive payloads are highly encouraging and could potentially revolutionize many cancer treatments known today."

Researchers at MSK developed naxitamab and the SADA Technology, which are exclusively licensed by MSK to Y-mAbs. As a result of these licensing arrangements, MSK has institutional financial interest related to the compound and technology and Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest, anaphylaxis, hypotension, bronchospasm and stridor and neurotoxicity, such as severe neuropathic pain, transverse myelitis and reversible posterior leukoencephalopathy syndrome. See full Prescribing Information for complete Boxed Warning and other important safety information.

On December 15, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the pricing of an underwritten public offering of 3,157,144 shares of its common stock, and to certain investors pre-funded warrants to purchase 1,142,856 shares of its common stock at an exercise price of $0.0001 (Press release, Syndax, DEC 15, 2021, View Source [SID1234597251]). The public offering price of each share of common stock is $17.50 and the public offering price of each pre-funded warrant is $17.4999 per underlying share, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds from this offering are expected to be approximately $75.3 million, before deducting underwriting discounts and commissions and other offering expenses payable by Syndax. In addition, Syndax granted the underwriters a 30-day option to purchase up to an additional 645,000 shares of common stock. All of the shares of common stock and pre-funded warrants are being sold by Syndax. The offering is expected to close on December 20, 2021, subject to customary closing conditions.

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Goldman Sachs & Co. LLC and Cowen are acting as joint book-running managers for the offering. BTIG is acting as lead manager for the offering. B. Riley Securities is acting as co-manager for the offering.

The shares are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement, final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected], or by phone at (833) 297-2926.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

On December 15, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported initiation of the dose-escalation stage of STELLAR-002, a phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors (Press release, Exelixis, DEC 15, 2021, View Source [SID1234597193]). The objective of the study is to evaluate the safety, tolerability and efficacy of XL092, Exelixis’ novel next-generation tyrosine kinase inhibitor (TKI), in combination with: nivolumab (OPDIVO); nivolumab and ipilimumab (YERVOY); and nivolumab and bempegaldesleukin.

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Exelixis is sponsoring STELLAR-002, and Bristol-Myers Squibb Company (NYSE: BMY) is providing nivolumab, ipilimumab and bempegaldesleukin for use in the trial, in accordance with their clinical trial collaboration and supply agreement announced in June. Nektar Therapeutics (Nasdaq: NKTR) will supply bempegaldesleukin to Bristol Myers Squibb through their existing global development and commercialization collaboration.

"The initiation of the dose-escalation stage of STELLAR-002, our second phase 1b trial of XL092, is an important step toward evaluating the potential of this next-generation tyrosine kinase inhibitor in combination with three additional immuno-oncology therapies for patients with advanced genitourinary tumors," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "We are pleased to continue our successful collaboration with Bristol Myers Squibb through this trial and look forward to identifying the recommended doses for the cohort-expansion stage."

The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the XL092 combination therapy regimens. Once the recommended dose is established, the trial will begin to enroll tumor-specific expansion cohorts for patients with advanced renal cell carcinoma, urothelial carcinoma and metastatic castration-resistant prostate cancer. The primary efficacy endpoint of the expansion stage will be objective response rates, except for the cohort of patients with metastatic castration-resistant prostate cancer, for which the primary endpoint will be duration of radiographic progression-free survival.

About XL092

XL092 is a next-generation oral tyrosine kinase inhibitor that targets kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. In designing XL092, Exelixis sought to build upon its extensive experience with cabozantinib, the company’s flagship medicine, retaining the target profile while improving key characteristics, including pharmacokinetic half-life. XL092 is currently being developed for the treatment of advanced solid tumors, including genitourinary cancers, as a monotherapy and in combination with immune checkpoint inhibitors. XL092 is the first internally discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug-discovery activities.

About Genitourinary Cancers

Genitourinary cancers are those that affect the urinary tract, prostate, testicles or penis — parts of the body involved in reproduction and urine production and excretion — and include renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC) and urothelial carcinomas.1

The American Cancer Society’s (ACS) 2021 statistics cite kidney cancer as among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S.2 Clear cell RCC is the most common type of kidney cancer in adults.3 Papillary RCC accounts for about 15% of all renal cell cancers.4,5 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 13%.2 Approximately 32,000 patients in the U.S. and over 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2021, with nearly 15,000 patients in need of a first-line treatment in the U.S.6
According to the ACS, in 2021, approximately 250,000 new cases of prostate cancer will be diagnosed, and 34,000 people will die from the disease.2 Prostate cancer that has spread beyond the prostate and does not respond to androgen-suppression therapies — a common treatment for prostate cancer — is known as metastatic CRPC.7 Researchers estimate that in 2020, 43,000 people were diagnosed with metastatic CRPC, which has a median survival of less than two years.8,9,10
Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively.11 Bladder cancer occurs mainly in older people, with 90% of patients aged 55 or older.12 With an estimated 84,000 new cases expected to be diagnosed in 2021, bladder cancer accounts for about 5% of all new cases of cancer in the U.S. each year.2,13 It is the fourth most common cancer in men.2