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Onconova Therapeutics Provides Corporate Update And Reports First Quarter 2020 Financial Results

On May 14, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported financial results for the quarter ended March 31, 2020, and provided a business update (Press release, Onconova, MAY 14, 2020, View Source [SID1234558170]).

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"With enrollment completed in March, Onconova’s pivotal Phase 3 INSPIRE trial is advancing to the next catalyst. We are fortunate to have achieved full enrollment of INSPIRE prior to the pandemic-driven disruptions to research studies at hospitals and cancer centers across the globe," said Steven M. Fruchtman, M.D., President and Chief Executive Officer. "Based on survival trends in the INSPIRE trial, we continue to anticipate reporting topline survival data in the second half of 2020. We expect to present the results of this trial at a major medical meeting later this year."

Dr. Fruchtman continued, "Beyond INSPIRE, we are primed for additional progress, including the to be initiated Phase 1/2a study of rigosertib plus nivolumab in Stage IV KRAS mutated lung adenocarcinoma, following the renewal of clinical cancer research programs post their COVID-mandated stoppage, as well as additional planned studies of rigosertib and our pipeline programs. We are preparing for and look forward to multiple corporate milestones in the second half of 2020."

First Quarter 2020 Developments and Recent Highlights

Completed enrollment of the pivotal Phase 3 INSPIRE trial
Opened investigator-initiated study of rigosertib plus nivolumab in Stage IV KRAS mutated lung adenocarcinoma
Re-acquired rights to rigosertib in Greater China
Next generation CDK 4/6 + ARK5 inhibitor, ON123300, IND approved in China
Nominated life sciences industry veteran Terri Shoemaker to the Company’s Board of Directors
Additional Upcoming Company Milestones Expected

Pivotal survival data from the INSPIRE trial expected in 2H 2020
European Hematology Association Virtual Congress presentation in June 2020:
Mutations in RAS Pathway Genes Correlates with Type of Failure to Azacitidine: Genomic Analysis at Randomization onto the Inspire Trial (EHA-4044)
Type C meeting to be requested in 2Q 2020 for a randomized Phase 2/3 study of the combination of oral rigosertib plus azacitidine
Expansion of the rigosertib investigator-initiated program to include KRAS mutated non-small cell lung cancer, melanoma and other RAS mutated-driven cancers
Next generation CDK 4/6 + ARK5 inhibitor, ON123300, US IND submission planned for 4Q 2020, and Phase 1 study commencement in China planned for 2H 2020
Anticipated launch of Early Access Program with Inceptua Medicines Group in 2H 2020
First Quarter 2020 Financial Results
Cash and cash equivalents as of March 31, 2020, totaled $31.0 million, compared to $22.7 million as of December 31, 2019. Common stock warrant exercises since our financing transaction in November 2019 have added $10.6 million to our balance sheet. Of the almost 29 million common stock warrants outstanding as of March 31, 2020, over 80% of them were in-the-money as of May 13th. Based on current projections, the Company continues to expect that its cash and cash equivalents as of March 31, 2020 will be sufficient to fund ongoing trials and operations into the third quarter of 2021.

Net loss was $5.1 million for the quarter ended March 31, 2020, compared to $7.6 million for the quarter ended March 31, 2019. Research and development expenses were $3.4 million for the quarter ended March 31, 2020 and $4.1 million for the comparable period in 2019. General and administrative expenses were $1.8 million for the quarter ended March 31, 2020 and $3.2 million for the comparable period in 2019.

Conference Call and Webcast Information
The Company will host a conference call today, May 14, 2020, at 4:30 p.m. Eastern Time, to provide a corporate update and discuss first quarter 2020 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S., or internationally (210) 229-8823 and using conference ID 3488818. The call will also be webcast live. Please click here to access the webcast. A replay will be available following the live webcast.

To facilitate an on-time conference call start, Onconova recommends that participants dial in 15 minutes before the 4:30 p.m. ET start time.

Aurinia Reports First Quarter 2020 Financial Results and Recent Operational Highlights

On May 14, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) ("Aurinia" or the "Company") reported financial results for the first quarter ended March 31, 2020 and provided an update on recent operational highlights (Press release, Aurinia Pharmaceuticals, MAY 14, 2020, View Source [SID1234558169]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

"We are fortunate that the global COVID-19 pandemic has had minimal impact on Aurinia’s operations, and we have maintained our timelines to ensure the filing of the voclosporin NDA by the end of the second quarter and hopefully obtain approval in early 2021," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Following the positive AURORA data reported last December we have strengthened the balance sheet, added world-class commercial expertise including the appointments of Timothy, Max, and Joe, and on-boarded a group of extraordinarily talented commercial leaders and additional staff."

Mr. Greenleaf further stated, "With the establishment of our commercial hub in Maryland, we’re building and preparing for the U.S. launch of voclosporin as the first FDA-approved treatment for lupus nephritis. In addition, the VOS development program remains on target, and we anticipate reporting out top-line results from the Phase 2/3 AUDREY dose-ranging trial of VOS during the fourth quarter of this year."

Dr. Neil Solomons, Chief Medical Officer of Aurinia commented, "With respect to FSGS, our exploratory study has been open for an extended period and due to the continued difficulty identifying and enrolling primary FSGS patients, we’ve decided to adjust our approach. We are preparing to evaluate voclosporin in other proteinuric kidney diseases, while continuing to support patients who have participated in the FSGS exploratory study. As we work to incorporate these broader populations further updates will be available later this year."

First Quarter 2020 Highlights

Pre-NDA Meeting with the U.S. Food & Drug Administration ("FDA") and Rolling New Drug Application ("NDA") Submission

Aurinia held a positive and successful Pre-NDA meeting with the FDA on February 25, 2020. The Company presented information about the safety and efficacy data to be included in the filing, reviewed the format and content of the planned application, and gained agreement on the rolling review plans for filing modules of the NDA. No obstacles were raised by FDA that would prevent submission of the complete NDA by the end of the second quarter as planned.
In March 2020, Aurinia filed the non-clinical module to the FDA followed by the chemistry, manufacturing and controls module in April 2020.
Aurinia remains on track to file the complete NDA to the FDA by the end of the second quarter of 2020.
Recent Director and Officer Appointments

Appointment of Timothy P. Walbert to the Board

On April 20, Aurinia announced the appointment of Mr. Walbert to the Board of Directors. Mr. Walbert has nearly 30 years of experience commercializing pharmaceutical products. Mr. Walbert is currently chairman, president and chief executive officer of Horizon Therapeutics plc. He also served as president, chief executive officer and director of IDM Pharma, Inc., a public biopharmaceutical company which was acquired by Takeda.

Appointment of Joe Miller as Chief Financial Officer

On April 27, Aurinia appointed Mr. Miller as Chief Financial Officer following the retirement of Mr. Dennis Bourgeault, who served in that role since 1998. Mr. Miller will be responsible for developing and leading the Company’s financial operations to effectively support the Company’s rapid growth. Mr. Bourgeault will remain an advisor to the Company to assist with the transition.

Appointment of Max Colao as Chief Commercial Officer and build out of world-class commercial team

On February 25, 2020, Aurinia announced the appointment of Max Colao to the newly created position of Chief Commercial Officer. In addition, Aurinia has recruited an experienced team of leaders responsible for key commercial functions including sales, marketing, market access, and commercial operations.

Financial Liquidity at March 31, 2020

As of March 31, 2020, Aurinia had cash, cash equivalents and short-term investments of $286.1 million compared to $306 million as at December 31, 2019. Net cash used in operating activities was $22.7 million for the first quarter ended March 31, 2020 compared to $13.1 million for the first quarter ended March 31, 2019.

The Company believes that it has sufficient financial resources to fund its current plans, which include conducting its ongoing research and development ("R&D") programs, completing the NDA submission to the FDA, conducting pre-commercial and launch activities, manufacturing and packaging commercial drug supply required for launch, and fund its supporting corporate and working capital needs through 2021.

Financial Results for the First Quarter Ended March 31, 2020

The Company reported a consolidated net loss of $16.5 million or $0.15 per common share for the first quarter ended March 31, 2020, as compared to a consolidated net loss of $12.4 million or $0.14 per common share for the first quarter ended March 31, 2019.

The loss for the first quarter ended March 31, 2020 reflected a reduction of $9.8 million in the estimated fair value of derivative warrant liabilities compared to a reduction of $1.7 million in the estimated fair value of derivative warrant liabilities for the first quarter ended March 31, 2019. The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by the Company. The outstanding warrants expire on December 28, 2021.

The loss before the change in estimated fair value of derivative warrant liabilities and income taxes was $26.6 million for the first quarter ended March 31, 2020 compared to $14.1 million for the same period in 2019.

R&D expenses increased to $13.8 million for the first quarter ended March 31, 2020 compared to $10.6 million for the first quarter ended March 31, 2019. The increase in these expenses primarily reflected higher costs related to the preparation of the NDA submission and related supporting activities, the ongoing VOS Phase 2/3 AUDREY trial, the AURORA 2 extension trial and the expansion of the medical affairs team to support the launch of voclosporin. Non-cash stock compensation expense charged to R&D also increased to $1.2 million for the first quarter ended March 31, 2020 compared to $862,000 for the comparable period in 2019 reflecting the hiring of a significant number of personnel in 2020 and an increase in the fair value of the stock options granted due to the increase in the Company’s share price.

Corporate, administration and business development expenses increased to $11.1 million for the first quarter of 2020 compared to $3.9 million for the first quarter of 2019. These expenses included the expansion of the commercial team, higher consulting and professional fees, insurance costs, and personnel compensation costs as the corporate organization buildout continued in the first quarter of 2020. Non-cash stock compensation expense charged to corporate, administration and business development also increased to $2.3 million for the first quarter ended March 31, 2020 compared to $742,000 for the comparable period in 2019 reflecting the hiring of a significant number of personnel in 2020 and an increase in the fair value of the stock options granted due to the increase in the Company’s share price.

This press release should be read in conjunction with our unaudited interim condensed consolidated financial statements and the Management’s Discussion and Analysis for the first quarter ended March 31, 2020 which are accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Aurinia will host a conference call and webcast to discuss the first quarter ended March 31, 2020 financial results today, Thursday, May 14, 2020 at 4:30 p.m. ET. The webcast can be accessed on the investor section of the Aurinia website at www.auriniapharma.com. To participate in the teleconference please dial +1-877-407-9170 (Toll-free U.S. & Canada).

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor ("CNI") with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. Voclosporin may result in a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (versus cyclosporine A), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable patent extension laws in other countries with anticipated pediatric extension. Further, a U.S. patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and AURORA trials into the product label.

CohBar Reports First Quarter 2020 Financial Results and Provides Business Update

On May 14, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported its financial results for the first quarter ended March 31, 2020 (Press release, CohBar, MAY 14, 2020, View Source [SID1234558168]).

"I am pleased to share with you that since my arrival at CohBar last May, we have expanded the number of programs from two to five with the newest targeting COVID-19 associated acute respiratory distress syndrome (ARDS)," said Steven Engle, CohBar’s Chief Executive Officer. "Recently, we announced that we have a new target for our CB5064 apelin agonist program, which is COVID-19 associated ARDS, an underlying disease that lacks adequate therapies. We are excited because published preclinical studies have shown that apelin can reduce the severity of acute lung injury. Also in this past quarter, we demonstrated that our recently discovered CXCR4 antagonist enhanced the effectiveness of a chemotherapeutic agent in a model of melanoma, and made additional progress with our antifibrotic program by generating new results in a therapeutic model of idiopathic pulmonary fibrosis (IPF). Finally, like many companies, we paused our Phase 1b study in NASH and obesity, which we hope to continue once the COVID-19 associated conditions impacting our study sites have improved. With this quarter’s accomplishments, CohBar continues to expand its portfolio of mitochondrial encoded peptides to maintain our leadership in mitochondrial medicine."

First Quarter 2020 R&D and Business Highlights

CB5064 Analogs for COVID-19 Associated ARDS and Type 2 Diabetes: In May, the company initiated testing of CB5064 analogs that interact with the apelin receptor in preclinical models of ARDS to assess their potential as therapeutics for COVID-19 associated ARDS. CohBar previously demonstrated the beneficial effects of this novel family of peptides on glucose tolerance, insulin sensitivity, and weight loss in an obese mouse model of T2D, as presented at the American Diabetes Association in 2019.

ATS Abstract Accepted for MBT2 Analogs for Fibrotic Diseases: In April, the company’s late-breaking abstract was accepted as a poster presentation at the American Thoracic Society (ATS) 2020 International Conference. The poster will summarize the prophylactic and therapeutic activity of a novel peptide, MBT2, in preclinical models of IPF. MBT2 has demonstrated reductions in lung fibrosis, inflammation, collagen levels, and other parameters. IPF is a chronic, progressive, debilitating and usually fatal interstitial lung disease that affects approximately 100,000 people in the U.S.

CB4211 Clinical Study Paused due to COVID-19 Pandemic: In March, the company announced delays in the completion of its CB4211 Phase 1b study for NASH and obesity due to the COVID-19 pandemic. CohBar has previously presented evidence that the novel mechanism of action of CB4211 enhances insulin effects on fat cells (adipocytes) leading to reduction of liver fat in preclinical models.

New CXCR4 Inhibitor Program Targets Cancer and Other Indications: In January, the company announced its discovery of MBT5 analogs, a novel family of potent and selective peptide inhibitors of the chemokine receptor, CXCR4. CXCR4 is overexpressed in more than 75% of cancers and high levels of the receptor are associated with poor survival prognosis.

Investment Community Outreach Continues to Expand: In this past quarter, CohBar held meetings with investors, analysts, and bankers in Boston, New York, and San Francisco. The company hosted meetings around the JP Morgan Healthcare, BIO CEO and ROTH conferences.

CohBar’s Chief Operating Officer Stepping Down from Management Role: Jon Stern, the company’s senior executive, will be stepping down from his role as COO on May 31, 2020. Since joining the company in 2012, Mr. Stern has served in various executive roles including Chief Strategic Officer and Chief Executive Officer. He will remain actively involved as a member of the company’s board of directors.
Founder’s Update

During the first quarter and subsequent period, Dr. Pinchas Cohen, Dean of the USC Leonard Davis School of Gerontology and Dr. Nir Barzilai, Director of the Institute for Aging Research at Albert Einstein College of Medicine, continued to be recognized as international leaders in the study of mitochondrial science, aging and age-related diseases.

Dr. Cohen published a paper linking MOTS-c to exercise performance in the journal Aging, titled "Increased expression of the mitochondrial derived peptide, MOTS-c, in skeletal muscle of healthy aging men is associated with myofiber composition." Dr. Barzilai delivered a keynote on "The Science and Economy of Aging" at the World Economy Forum in Davos, Switzerland in January. He also spoke on longevity and the science of aging in San Francisco, Singapore, Abu Dhabi, Tel Aviv, and Naples, Florida.

First Quarter 2020 Financial Highlights

Cash and Investments. CohBar had cash and cash equivalents of $10.2 million as of March 31, 2020, compared to $12.6 million as of December 31, 2019. The cash burn for the quarter ended March 31, 2020, was approximately $2.5 million.

R&D Expenses. Research and development expenses were similar for the three months ended March 31, 2020 and the prior year quarter at $1.4 million.

G&A Expenses. General and administrative expenses were $1.8 million for the three months ended March 31, 2020, compared to $1.5 million in the prior year quarter. The increase in general and administrative expenses was primarily due to higher D&O insurance premiums, board fees and stock-based compensation costs.

Net Loss. For the three months ended March 31, 2020, net loss, which included $1.8 million of non-cash expenses, was $4.2 million, or $0.10 per basic and diluted share. For the three months ended March 31, 2019, net loss, which included $0.9 million of non-cash expenses, was $2.9 million, or $0.07 per basic and diluted share.
First Quarter Investor Call and Slide Presentation:

Date: May 14, 2020
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

Dial-in U.S. and Canada: (877) 451-6152
Dial-in International: (201) 389-0879
Conference ID No.: 13702385
Slide Presentation

Go to www.webex.com, click on the ‘Join a Meeting’ button and enter meeting number 923 145 161 and Password CWBR, or
Go to www.cohbar.com and click on Q1 2020 Shareholder Presentation at top of homepage.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Webex approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on May 14, 2020, through 11:59 p.m. Eastern Time on June 4, 2020. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13702385. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

Significant Improvement in Overall Survival with ERLEADA®▼ (apalutamide) for Patients with Non-Metastatic Castration-Resistant Prostate Cancer

On May 14, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA▼ (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1 Results will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Programme (Abstract #5516) beginning on Friday 29th May.1 (Press release, Janssen Pharmaceuticals, MAY 14, 2020, View Source [SID1234558161])

Findings from the study showed that apalutamide in combination with ADT prolonged median overall survival by 14 months and decreased the risk of death by 22 percent.1 Median OS was significantly longer, with 73.9 months for patients receiving treatment with apalutamide in combination with ADT compared to 59.9 months with patients receiving placebo in combination with ADT [HR=0.78; p=0.0161 (to reach statistical significance, a p-value of p<0.046 needed to be observed)].1 After the study met its primary endpoint of metastasis-free survival (MFS), the SPARTAN study was unblinded and patients on placebo were allowed to crossover to apalutamide. The OS results were achieved despite a crossover of 76 randomised placebo patients (19 percent) to apalutamide treatment.1 After adjusting for the cross-over of patients in the placebo arm, the treatment effect of apalutamide plus ADT exceeded median OS compared to placebo plus ADT with a difference of 21 months between the two arms (73.9 months vs 52.8 months, respectively, HR=0.69, p=0.0002). Additionally, treatment with apalutamide in combination with ADT significantly delayed patients’ time to cytotoxic chemotherapy compared to placebo in combination with ADT (HR=0.63; p=0.0002).1

"Treatment for patients with non-metastatic castration-resistant prostate cancer is primarily focused on delay of metastases and improvement of overall survival," said Eric Small, M.D., FASCO, Professor of Medicine, and Chief Scientific Officer at the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, and lead SPARTAN study investigator. "The final analysis of SPARTAN includes long-term data for each of these treatment parameters and helps to support the earlier use of apalutamide versus ADT alone."

Together with data from the primary analysis, the SPARTAN study has met all primary, secondary and exploratory endpoints. The primary endpoint of the study was MFS; the secondary endpoints were time to metastasis, progression-free survival (PFS), time to symptomatic progression, OS and time to initiation of cytotoxic chemotherapy; and the exploratory endpoints were second progression-free survival (PFS2), PSA responses and risk of PSA progression.1,2

"Our driving commitment to delay the onset of metastases and add years to life for prostate cancer patients has taken a significant step forward with today’s data," said Dr Joaquín Casariego, M.D., Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "The SPARTAN trial has successfully demonstrated that apalutamide improved overall survival by an average of 14 months, reinforcing the need to treat earlier in prostate cancer for the benefit of patients and their families. At Janssen, our vision is to pioneer new approaches to treating cancer by thinking differently about diagnosis and looking towards intercepting the disease before it can even take a hold."

Median treatment duration was nearly three times longer for patients treated with apalutamide plus ADT (33 months) compared with those treated with placebo plus ADT (12 months).1 Grade 3/4 treatment-emergent adverse events of special interest were rash (5.2 percent), fractures (4.9 percent), falls (2.7 percent), ischemic heart disease (2.6 percent), hypothyroidism (0 percent) and seizures (0 percent). Safety and tolerability of apalutamide is consistent and as reported previously.1,3

Initial results from the SPARTAN trial were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in The New England Journal of Medicine.2,4 The study met its primary endpoint of MFS demonstrating a median MFS of more than two years (difference of 24.31 months) and a 72 percent reduction in risk of distant metastasis in patients with nmCRPC.4 OS data were not mature at the time of the final MFS analysis (24 percent of the required number of events). Updated results were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in 2019 and were simultaneously published in Annals of Oncology.5,6

#ENDS#

About the SPARTAN Study
SPARTAN (NCT01946204) is a Phase 3, randomised, registrational, double-blind, placebo-controlled, multicentre study that evaluated ERLEADA (apalutamide) in combination with ADT in men with nmCRPC with a rapidly rising PSA (PSA Doubling Time ≤10 months).2,7 The SPARTAN study enrolled 1,207 patients who were randomised 2:1 to receive either apalutamide orally at a dose of 240 mg once daily in combination with ADT (n=806) or placebo once daily in combination with ADT (n=401).4

About Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (nmCRPC) refers to a disease stage in which the cancer no longer responds to treatments that lower testosterone but has not yet been discovered in other parts of the body using a total body bone scan and/or CT/MRI scan.8 Features include: lack of detectable metastatic disease using conventional radiographic imaging and rapidly rising PSA while on ADT with serum testosterone level below 50 ng/dL.9,10 Ninety percent of patients with nmCRPC will eventually develop metastases, which can lead to pain, fractures and other symptoms.11 The relative five-year survival rate for patients diagnosed with a distant-stage prostate cancer is 31 percent.12 It is critical to delay the development of metastasis in patients with nmCRPC.

About ERLEADA
ERLEADA (apalutamide) is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease and in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).7 In the U.S. apalutamide is indicated for the treatment of nmCRPC and mHSPC.13

Warnings and Precautions include ischemic heart disease, fractures, falls and seizure.2,3 In the SPARTAN study, the most common adverse reactions (≥10 percent) were fatigue, hypertension, rash, diarrhoea, nausea, weight decreased, arthralgia, falls, hot flush, decreased appetite, fracture and peripheral edema.1,4

ADC THERAPEUTICS ANNOUNCES PRICING OF UPSIZED INITIAL PUBLIC OFFERING

On May 14, 2020 ADC Therapeutics SA, a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported the pricing of the initial public offering of 12,245,631 shares of its common shares at a price of $19.00 per share (Press release, ADC Therapeutics, MAY 14, 2020, View Source [SID1234558148]). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by ADC Therapeutics, are expected to be approximately $232.7 million. The shares are expected to begin trading on the New York Stock Exchange on May 15, 2020 under the ticker symbol "ADCT." The offering is expected to close on May 19, 2020, subject to customary closing conditions. In addition, ADC Therapeutics has granted the underwriters a 30-day option to purchase up to 1,836,844 additional common shares.

Morgan Stanley, BofA Securities and Cowen are acting as joint book-running managers for the offering.

The offering is being made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained, when available, from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at [email protected]; BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. 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 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. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of ADC Therapeutics SA, such as the common shares, in or into Switzerland within the meaning of the Swiss Financial Services Act ("FinSA") and these securities will not be listed or admitted to trading on the SIX Swiss Exchange or on any other regulated trading venue (exchange or multilateral trading facility) in Switzerland. Neither this document nor any other offering or marketing material relating to these securities, such as the common shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares may be publicly distributed or otherwise made publicly available in Switzerland.