On April 27, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported first quarter 2020 financial results on Thursday, May 7, 2020, after the close of U.S. markets (Press release, CytomX Therapeutics, APR 27, 2020, View Source [SID1234556616]). Following the announcement, the company will host a conference call beginning at 5:00 p.m. ET to discuss its results.

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Participants may access the live audio webcast of the teleconference from the "Investors & News" section of CytomX’s website at View Source Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Audio Conference Call:

U.S. Dial-in Number: (877) 809-6037

International Dial-in Number: (615) 247-0221

Conference ID: 6282129
An archived webcast replay will be available on the Company’s website from May 7, 2020, until May 14, 2020.

On April 27, 2020, Sorrento Therapeutics, Inc. (the "Company") reported that entered into a Sales Agreement (the "Sales Agreement") with A.G.P./Alliance Global Partners, as sales agent (the "Agent"), pursuant to which the Company may offer and sell, from time to time, through or to the Agent, as sales agent and/or principal (the "Offering") up to $250,000,000 in shares of its common stock (the "Shares") (Filing, 8-K, Sorrento Therapeutics, APR 27, 2020, View Source [SID1234556634]). Any Shares offered and sold in the Offering will 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 relating to the Offering, dated April 27, 2020, that will be filed with the SEC.

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Subject to the terms and conditions of the Sales Agreement, the Agent will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. Under the Sales Agreement, the Agent may sell the Shares 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 "Securities Act").

The Company has no obligation to sell any of the Shares, and may at any time suspend offers under the Sales Agreement. The Offering will terminate upon (a) the election of the Agent upon the occurrence of certain adverse events, (b) three business days’ advance notice from one party to the other, or (c) the sale of all of the Shares.

Under the terms of the 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 under the Sales Agreement. The Company will also reimburse the Agent for certain expenses incurred in connection with the Sales Agreement, and agreed to provide indemnification and contribution to the Agent with respect to certain liabilities, including liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended.

The Company currently intends to use any 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 proceeds to repay indebtedness owed under that certain Term Loan Agreement that the Company and certain of its domestic subsidiaries entered into with certain funds affiliated with Oaktree Capital Management, L.P. and Oaktree Fund Administration, LLC, as administrative and collateral agent, as amended.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 1.1 hereto and 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 the Shares, nor shall there be any offer, solicitation or sale of the Shares 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.

Common Stock Purchase Agreement

On April 27, 2020, the Company entered into a Common Stock Purchase Agreement (the "Purchase Agreement") with Arnaki Ltd., a British Virgin Islands corporation (the "Purchaser"), pursuant to which the Purchaser is committed to purchase up to an aggregate of $250.0 million of shares of the Company’s common stock ("Common Stock") over the 36-month term of the Purchase Agreement on the terms set forth therein (the "CSPA Offering").

The Company will file with the SEC a prospectus supplement to the Form S-3, dated April 27, 2020, registering all of the shares of Common Stock that may be offered and sold to the Purchaser pursuant to the Purchase Agreement from time to time.

Pursuant to the terms of the Purchase Agreement, on any business day over the 36-month term of the Purchase Agreement (each, a "Purchase Date"), the Company has the right, in its sole discretion, to present the Purchaser with a purchase notice (each, a "Purchase Notice") directing the Purchaser to purchase up to 650,000 shares of Common Stock per business day. The Company and the Purchaser also may mutually agree to increase the number of shares that may be sold to as much as an additional 3,600,000 shares per Purchase Date. In addition to such purchases, the Company has the right, in its sole discretion, to grant the Purchaser an option to purchase an additional amount of shares of Common Stock, subject to a maximum number of shares determined by the Company on each Purchase Date. Pursuant to the Purchase Agreement, in no event shall the aggregate purchase price paid by the Purchaser exceed $5,000,000 per Purchase Date, unless mutually agreed by the Company and the Purchaser. The purchase price of the Common Stock pursuant to the Purchase Agreement will be equal to 97.5% of the daily volume weighted average purchase price of the Common Stock on the Purchase Date (the "Purchase Price").

The Purchaser will not be required to, but may at its option, buy shares of Common Stock pursuant to a Purchase Notice that was received by the Purchaser on any day on which either (i) the daily volume-weighted average purchase price of the Common Stock is below $1.10 (which shall not be subject to adjustment for any reorganization, recapitalization, stock dividend, stock split, reverse stock split or other similar transaction), or (ii) the Purchase Price for such day is below $1.10 per share. The Purchaser has no right to require any sales by the Company, but is obligated to make purchases from the Company as directed by the Company in accordance with the Purchase Agreement. There are no limitations on the use of proceeds, financial or business covenants, restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. The Company may terminate the Purchase Agreement at any time, in the Company’s discretion, without any cost or penalty. The Purchaser may terminate the Purchase Agreement at any time that an event of default exists without any liability or payment to the Company. Pursuant to the Purchase Agreement, the Purchaser agreed that during the term of the Purchase Agreement, neither it nor any of its affiliates or any entity managed or controlled by it will, directly or indirectly, engage in any short sales involving the Company’s securities or grant an option to purchase, or acquire any right to dispose of or otherwise dispose for value of, any shares of Common Stock or any securities convertible into or exercisable or exchangeable for any shares of Common Stock, or enter into any swap, hedge or other similar agreement that transfers, in whole or in part, the economic risk of ownership of any shares of Common Stock. The Company expects to use any proceeds it receives under the Purchase Agreement for working capital and general corporate purposes.

The foregoing description of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the copy of the Purchase Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.

The representations, warranties and covenants contained in the Purchase Agreement were made solely for the benefit of the parties to the Purchase Agreement, and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Purchase Agreement and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the SEC.

A copy of the opinion of Paul Hastings LLP, counsel to the Company, relating to the validity of the shares of Common Stock to be issued in the Offering and the CSPA Offering is filed with this Current Report on Form 8-K as Exhibit 5.1.

On April 27, 2020 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, reported that new pharmacokinetic and target engagement data from its Phase 1 study of PEN-866 in patients with solid tumor malignancies at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting (Press release, Tarveda Therapeutics, APR 27, 2020, View Source [SID1234556654]). PEN-866 is the initial clinical program from Tarveda’s HSP90 binding miniature drug conjugate platform, and is designed to bind to activated Heat Shock Protein 90 (HSP90) to accumulate and release its potent topoisomerase 1 inhibitor (SN-38) payload in solid tumors. The poster titled, "Characterization of PEN-866, a Heat Shock Protein 90 (HSP90) binding conjugate of SN-38, in patient plasma and tumors from the first in human study", showcased confirmatory pharmacokinetics of PEN-866 in patient plasma and highlighted data from two patient biopsies, which confirmed higher concentrated levels of the PEN-866 conjugate and SN-38 payload in tumor relative to plasma.

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"The plasma pharmacokinetic data from the dose escalation portion of our Phase 1/2a clinical trial demonstrated that PEN-866 exhibited favorable plasma pharmacokinetics as predicted from our preclinical data, with PEN-866 remaining intact while in circulation. Unconjugated SN-38 remained very low at approximately 2% of the PEN-866 exposure in circulation," said Mark Bilodeau, Ph.D., Chief Scientific Officer of Tarveda. "We are also very encouraged by the tumor biopsy data, which showed tumor uptake and retention of PEN-866 as well as the subsequent release of SN-38, which was significantly increased in comparison to the presence of PEN-866 and released SN-38 in plasma at days 1 and 7/8 after dosing. These data are consistent with PEN-866 preclinical data showing materially increased uptake and retention of PEN-866 in the tumor versus untargeted forms of SN-38, such as irinotecan."

Dr. Bilodeau continued, "the preferential tumor targeting and release of SN-38 seen in the tumors with PEN-866 serves as a firm foundation for the broader potential of the platform to produce new HSP90 binding miniature drug conjugates with promising anti-cancer payloads."

"The clinical and preclinical results seen to date show that PEN-866 accumulates and is retained in tumors where it is then released over multiple days at therapeutic levels. This is in contrast to plasma where the conjugate remains intact and is quickly cleared from the circulation, helping to spare potential damage to normal tissue," said Jeffrey Bloss, M.D., Chief Medical Officer of Tarveda. "These data support the miniature conjugate design of PEN-866 and are a contributor to the beneficial therapeutic index seen with PEN-866 in Phase 1. We are excited to work with PEN-866 in Phase 2a and believe its development should be explored as a single agent and in combination with other exciting therapeutics, such as PARP inhibitors and immuno-oncology drugs that have struggled to successfully combine with cytotoxic therapies."

PEN-866 Phase 1 Study Design & Results

Thirty patients with advanced solid tumor malignancies were enrolled in the Phase 1 dose escalation cohorts and received PEN-866 on days 1, 8, and 15 in 28-day cycles over a dose range of 16-228 mg/m2. The PEN-866 plasma concentration profile showed a concentration decline after end of infusion resulting in an average half-life of approximately 7 hours. PEN-866 plasma concentrations up to 39 µg/mL and area under the concentration curve of 57 h·µg/mL were achieved and determined for the recommended Phase 2a dose. Of the 30 patients, two consented to tumor biopsy collection to determine PEN-866 and SN-38 accumulation. Biopsy results from a pancreatic cancer patient who received a 150 mg/m2 dose of PEN-866 showed that PEN-866 and SN-38 levels in the tumor were significantly higher than observed in plasma 24 hours post dose and that the ratio of SN-38 to PEN-866 was high in tumor and low in plasma. Results from a patient with esophageal cancer who received a 175 mg/m2 dose of PEN-866 on day one and underwent tumor biopsy on day seven showed continued exposure of PEN-866 and SN-38 in the tumor. While in the plasma, PEN-866 was extremely low and SN-38 was unmeasurable (on day 8). These biopsy results support previous preclinical data showing that PEN-866 slowly releases its SN-38 payload in the tumor over multiple days.

Overall the data show that PEN-866 demonstrated favorable plasma pharmacokinetics with low levels of SN-38 observed in plasma. More importantly, both the conjugate and released payload (SN-38) were concentrated and retained in the tumor for up to a week. PEN-866 recently completed the Phase 1 all-comers, dose escalation and safety portion of a Phase 1/2a clinical trial. Additional information on the Phase 1/2a clinical trial for PEN-866 is available at clinicaltrials.gov, through identifier number NCT03221400.

On April 27, 2020 ROME Therapeutics, a biotechnology company harnessing the power of the repeatome in drug development, reported that launched with $50 million in Series A funding from GV, ARCH Venture Partners and Partners Innovation Fund (Press release, Rome Therapeutics, APR 27, 2020, View Source [SID1234556617]). ROME was founded to discover and develop novel therapies for cancer and autoimmune diseases by leveraging new insights from the vast uncharted territory of the repeatome – the roughly 60% of the human genome consisting of repetitive sequences of nucleic acids, known as repeats. Drawing on deep expertise in oncology, virology, immunology and machine learning, the ROME team has identified several promising drug targets and launched multiple discovery programs.

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The overwhelming majority of industry drug discovery programs target the roughly 2% of the human genome which encodes for proteins. Repeats have long been dismissed as "junk DNA." However, recent discoveries at this frontier of biology have made it clear that the repeatome is a rich and complex ecosystem. Among other elements, it contains the remnants of ancient viruses which have integrated into the human genome over time. In addition to being vital for embryonic development, these viral-like strands of genetic material are activated in times of stress and may play a significant role in driving diseases such as cancer, as malignant cells co-opt the repeats to facilitate their own survival and growth. These insights are the foundation of ROME’s pioneering work to discover and develop repeatome-based therapeutics.

ROME is led by CEO, President and Co-founder Rosana Kapeller, M.D., Ph.D., who incubated the company during her tenure as an entrepreneur-in-residence at GV, where she is currently a Fellow. In her previous role as founding Chief Scientific Officer at Nimbus Therapeutics, Dr. Kapeller led the company’s initiative to apply advanced computational technologies to the design and development of novel therapeutics. Notably, she led discovery and development of a new class of acetyl-CoA carboxylase (ACC) inhibitors for NASH, later acquired by Gilead Sciences.

"At ROME, we have set out a bold goal: To drive even the most difficult-to-treat cancers and autoimmune diseases into sustained remission," Dr. Kapeller said. "Too many patients do not benefit from today’s therapies, or experience only a partial response that quickly fades. We believe the repeatome holds the key to longer-lasting interventions. Our scientific founders together with our team have made excellent progress in exploring this uncharted territory and identifying promising therapeutic paths. With the support of our outstanding investors and advisors, we’re moving quickly to advance our therapeutic programs."

"By targeting this uncharted territory, ROME has the potential to open up huge new stretches of the genome for drug discovery," said Kristina Burow, Managing Director, ARCH Venture Partners and a member of ROME’s Board of Directors. "We are thrilled to be working alongside the ROME team as they seek to develop novel therapies for intractable cancers and autoimmune diseases."

"Rosana has brought together some of the best minds in oncology, immunology, virology and machine learning to create a novel approach to harnessing the power of the repeatome," said Krishna Yeshwant, M.D., General Partner at GV and a member of ROME’s Board of Directors. "We believe that ROME has the insights and expertise to turn cutting-edge discoveries in this field into an important new class of medicines, and we’re proud to continue working with Rosana and her team as they drive their programs forward."

On April 27, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI or the Company), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported the closing of its previously announced underwritten public offering and the exercise in full of the underwriters’ option to purchase additional shares (Press release, VBI Vaccines, APR 27, 2020, View Source [SID1234556635]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by VBI, are approximately US$57.5 million. 52,272,726 common shares, at a public offering price of US$1.10 per share, were issued and sold in this offering, which includes 6,818,181 shares issued upon the exercise of the underwriters’ option to purchase additional shares.

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Immediately following the closing of the underwritten public offering, the number of outstanding common shares of the Company is 230,648,396.

Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. acted as joint book-running managers, and National Securities Corporation, a wholly-owned subsidiary of National Holdings, Inc. (Nasdaq: NHLD), acted as lead manager for the underwritten public offering.

VBI intends to use the net proceeds from the offering to support the regulatory filings, pre-commercialization, and launch planning activities for Sci-B-Vac in the United States, Europe, and Canada, for the continued advancement of its pipeline programs, including the development of VBI-1901, a cancer vaccine immunotherapeutic candidate for recurrent glioblastoma (GBM); VBI-2601, an immunotherapeutic candidate for chronic hepatitis B infection; VBI-1501, a prophylactic cytomegalovirus (CMV) vaccine candidate; and VBI-2901, a prophylactic pan-coronavirus vaccine candidate. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (SEC) and declared effective on July 30, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering was filed with the SEC on April 21, 2020. A final prospectus supplement and accompanying prospectus, dated April 22, 2020, relating to the offering was filed with the SEC on April 24, 2020, and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may also be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail 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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.