On May 2, 2023 Ten63 Therapeutics, a company combining generative AI and physics-based models to develop first- and best-in-class therapeutics, reported the closing of an oversubscribed $15.9 million Series A financing led by new investor Hatteras Venture Partners (Press release, Ten63 Therapeutics, MAY 2, 2023, View Source [SID1234632173]). Morpheus Ventures, SOSV, Draper Associates, Alexandria Venture Investments, the Sigma Group and other new investors also participated in the round.

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Proceeds will be used to advance and expand Ten63’s internal pipeline of first-in-class small molecules inhibiting high-impact, but thus far undruggable, cancer targets, including continued progression of its lead Myc inhibitor program. Key to Ten63’s pipeline is the continued development of BEYOND, Ten63’s proprietary computational drug discovery platform. The financing also allows Ten63 to selectively enter key strategic partnerships to further enhance its pipeline.

"We are thrilled to welcome some of the leading biotechnology and technology venture funds to accelerate our pipeline and platform," said Marcel Frenkel, PhD, CEO of Ten63. "At Ten63, we are dedicated to developing groundbreaking therapeutics that benefit patients, and we are pleased to strengthen our syndicate with the experience and expertise to help us get there. Our investors have repeatedly demonstrated the ability to help companies grow to have a positive impact on patients’ lives. We look forward to building on that tradition."

"Marcel Frenkel, Mark Hallen and the Ten63 team have taken AI/machine learning (ML) drug discovery to the next level. Their approach enables the search of a massively expanded universe of compounds and binding pockets," said Clay Thorp, Co-Founder and General Partner at Hatteras and Ten63’s new Chairman of the Board. "We are excited to be a part of Ten63 and help the company leverage its platform to bring life-changing therapeutics to patients."

This new phase of growth builds on Ten63’s unprecedented progress toward one of the most sought-after cancer therapeutics: a small-molecule drug targeting Myc.

"We are more than doubling our investment because Ten63 has experimentally demonstrated in head-to-head comparisons that BEYOND outperforms over 40 years of academic and industry best-efforts and methods when pursuing difficult targets like Myc," said Damien Petty, Partner at Morpheus Ventures, the lead investor of Ten63’s previous round.

Set on drugging the "undruggable"

Ten63’s journey began with Dr. Frenkel’s mother, Gilda Szacher Frenkel.

"Like many, her cancer was driven by a set of mutations to key proteins that regulate cellular processes. Unfortunately, most of these proteins, despite being widely studied, remain undruggable by current methods," said Dr. Frenkel. "Ten63 has set out with a vengeance to change this paradigm through the application of next-generation computational drug discovery methods."

Despite advances in drug discovery, 80% of the proteins in the human body remain evasive, and some of these so-called "undruggable" proteins are believed to be major oncogenes (cancer-driving proteins). Ten63 is progressing multiple targets within its pipeline, but is currently only disclosing its lead program, a Myc inhibitor. Myc is one of the most-studied oncogenes and believed to drive up to 70% of all cancers. Despite hundreds of attempts spanning 40 years, it remains infamously elusive. Ten63 believes its computational platform BEYOND has the potential to crack Myc, as well as other undruggable oncogenes, transforming the treatment landscape for patients.

Ten63 developed the BEYOND platform based on over 15 years of academic research by its founders.

"Rather than depending on data alone, BEYOND builds on molecular voxel theory (MVT)," said Mark Hallen, PhD, Ten63’s co-founder and CTO,. "MVT allows BEYOND to explore a chemical space of over 100 trillion compounds, with mathematical guarantees to discover the best small molecule solutions given the company’s state-of-the-art hybrid AI/physics-based models. BEYOND also enables Ten63 to find novel pockets and binding sites, as well as a large diversity of chemical matter."

A visionary team combining pharma experience and cutting-edge technology

Drs. Frenkel and Hallen and their co-founder Bruce Donald, PhD, worked together for years on the academic precursors to these algorithms. Dr. Donald, the James B. Duke Professor of Computer Science at Duke University and professor of chemistry and biochemistry, chairs Ten63’s scientific advisory board. Their work pioneered the prediction of resistance mutations to cancer drugs and antibiotics before they arise in the clinic and the application of ML to scale cutting-edge, quantum chemistry-based models to the massive chemical and conformational spaces needed for drug discovery. In addition to a groundbreaking computational protein and drug design background, launching Ten63 required a much broader range of expertise.

Ten63 has assembled a visionary team of accomplished chemists, biologists and computational experts to accomplish its mission. The team ranges from experienced pharma executives like Nancy Miller-Rich, previously global head of BD and Strategy at Merck, and Melissa Epstein, formerly SVP at Novartis, to drug hunters like Stephen Thomson, PhD, formerly section head at GSK and research fellow at Vertex, and Charlie Holst, PhD, formerly senior director at Ribometrix and previously senior principal scientist at Pfizer. The company also taps into the expertise of a world-class scientific advisory board, including two MacArthur (Genius) Fellowship award winners and one Squirrel AI award winner, as well as members of the National Academies of Medicine, Science and Engineering.

"Much of our algorithmic strategy at Ten63 is built on synthesizing the diverse lines of seminal research that our advisors have pioneered," said Dr. Hallen.

"Ten63’s provable AI algorithms for the exploration of vast chemical and conformational spaces, combined with the accuracy of ML-accelerated quantum chemistry methods, have the potential to revolutionize how we design drugs," said Weitao Yang, PhD, one of the world’s foremost experts in computational quantum chemistry and Ten63’s SAB member.

On May 2, 2023 Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2023 and reaffirmed full-year 2023 financial guidance (Press release, Pfizer, MAY 2, 2023, View Source [SID1234631632]).

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The first-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.

Incyte has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 2, 2023, Veru Inc. (the "Company"), reported to have entered into a purchase agreement (the "Purchase Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park" or "Investor") (each, a "Party", and together, the "Parties"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company may sell to Lincoln Park up to $100,000,000 of shares (the "Purchase Shares") of the Company’s common stock, par value $0.01 per share (the "Common Stock") over the 36 month term of the Purchase Agreement (Press release, Veru, MAY 2, 2023, View Source [SID1234630944]). Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with Lincoln Park, pursuant to which it agreed to provide Lincoln Park with certain registration rights related to the shares issued under the Purchase Agreement (the "Registration Rights Agreement").

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From and after the Commencement Date (as defined in the Purchase Agreement), the Company has the right, but not the obligation, on any business day selected by the Company (the "Purchase Date"), provided that on such day the closing sale price per-share of the Common Stock is above the Floor Price, as defined in the Purchase Agreement, to require Lincoln Park to purchase up to 225,000 shares of Common Stock (the "Regular Purchase Amount") at the Purchase Price (as defined below) per purchase notice (each such purchase, a "Regular Purchase") provided, however, that (1) the limit on the Regular Purchase Amount will be increased to 250,000 shares, if the closing sale price of the Common Stock on the applicable Purchase Date is not below $6.00 and to 275,000 shares, if the closing sale price of the Common Stock on the applicable Purchase Date is not below $8.00. Lincoln Park’s committed obligation under each Regular Purchase shall not exceed $2,500,000 or 2,000,000 Purchase Shares per each Regular Purchase. The purchase price for Regular Purchases (the "Purchase Price") shall be equal to the lesser of: (i) the lowest sale price of the Common Stock during the Purchase Date, or (ii) the average of the three lowest closing sale prices of the Common Stock on the 10 consecutive business days ending on the business day immediately preceding such Purchase Date. The Company shall have the right to submit a Regular Purchase notice to the Investor as often as every business day. A Regular Purchase notice is delivered to the Investor after the market has closed (i.e., after 4:00 P.M. Eastern Time) so that the Purchase Price is always fixed and known at the time the Company elects to sell shares to Lincoln Park.

In addition to Regular Purchases and provided that the Company has directed a Regular Purchase in full, the Company in its sole discretion may require Lincoln Park on each Purchase Date to purchase on the following business day ("Accelerated Purchase Date") up to the lesser of (i) three (3) times the number of shares purchased pursuant to such Regular Purchase or (ii) 30% of the trading volume on the Accelerated Purchase Date (the "Accelerated Purchase") at a purchase price equal to the lesser of 97% of (i) the closing sale price on the Accelerated Purchase Date, or (ii) the Accelerated Purchase Date’s volume weighted average price (the "Accelerated Purchase Price").

The Company may also direct Lincoln Park, on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Purchase Agreement, to make additional purchases upon the same terms as an Accelerated Purchase (an "Additional Accelerated Purchase").

The purchase price of Regular Purchases, Accelerated Purchases and Additional Accelerated Purchases and the minimum closing sale price for a Regular Purchase will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction occurring during the business days used to compute the purchase price. The aggregate number of shares that the Company can sell to Lincoln Park under the Purchase Agreement may in no case exceed 17,678,502 shares (subject to adjustment as described above) of Common Stock (which is equal to approximately 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement) (the "Exchange Cap"), unless (i) shareholder approval is obtained to issue Purchase Shares above the Exchange Cap, in which case the Exchange Cap will no longer apply, or (ii) the average price of all applicable sales of Common Stock to Lincoln Park under the Purchase Agreement equals or exceeds $1.26 per share (subject to adjustment as described above) (which represents the Minimum Price, as defined under Nasdaq Listing Rule 5635(d), on the Nasdaq Capital Market immediately preceding the signing of the Purchase Agreement, such that the transactions contemplated by the Purchase Agreement are exempt from the Exchange Cap limitation under applicable Nasdaq rules).

The Purchase Agreement contains customary representations, warranties, covenants, closing conditions, indemnification and termination provisions. Sales under the Purchase Agreement may commence only after certain conditions have been satisfied, which conditions include the delivery to Lincoln Park of a prospectus supplement covering the shares of Common Stock issued or sold by the Company to Lincoln Park under the Purchase Agreement, the filing with the Nasdaq Stock Market of a Listing of Additional Shares notification with respect to the shares and Nasdaq having raised no objection to the consummation of transactions contemplated under the Purchase Agreement, and the receipt by Lincoln Park of a customary opinion of counsel and other certificates and closing documents.

The Purchase Agreement may be terminated by the Company at any time, at its sole discretion, without any cost or penalty, by giving one business day notice to Lincoln Park to terminate the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of Common Stock. On the Commencement Date we also will issue 800,000 shares of the Common Stock to Lincoln Park as an initial fee for its commitment to purchase shares of Common Stock under the Purchase Agreement, and we are obligated to issue $1,000,000 of shares of Common Stock at the time Lincoln Park’s purchases cumulatively reach an aggregate amount of $50,000,000 of Purchase Shares (together the "Commitment Shares").

There are no limitations on the use of proceeds, financial or business covenants, restrictions on future financings (other than restrictions on the Company’s ability to enter into a similar type of agreement or equity line of credit until the Maturity Date, as defined in the Purchase Agreement), rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. The Company may deliver Purchase Notices under the Purchase Agreement, subject to market conditions, and in light of its capital needs, from time to time and under the limitations contained in the Purchase Agreement. Any proceeds that the Company receives under the Purchase Agreement are expected to be used for working capital and general corporate purposes.

The issuance of the Purchase Shares and Commitment Shares have been registered pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-270606) (the "Registration Statement"), and the related base prospectus included in the Registration Statement, as supplemented by a prospectus supplement to be filed on or around the Commencement Date (the "Prospectus Supplement"). A copy of the legal opinion as to the legality of the Shares, as defined therein, is filed as Exhibit 5.1 attached hereto.

The foregoing is a summary description of certain terms of the Purchase Agreement and the Registration Rights Agreement and, by its nature, is incomplete. Copies of the Purchase Agreement and the Registration Rights Agreement are filed as Exhibits 10.1 and 10.2 attached hereto. The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to such exhibits. The Purchase Agreement and Registration Rights Agreement contain customary representations and warranties, covenants and indemnification provisions that the parties made to, and solely for the benefit of, each other in the context of all of the terms and conditions of such agreements and in the context of the specific relationship between the parties thereto. The provisions of the Purchase Agreement and the Registration Rights Agreement, including any representations and warranties contained therein, are not for the benefit of any party other than the parties thereto and are not intended as documents for investors and the public to obtain factual information about the current state of affairs of the parties thereto. Rather, investors and the public should look to other disclosures contained in the Company’s annual, quarterly and current reports it may file with the Securities and Exchange Commission.

The information contained in this Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the shares of the Common Stock discussed herein, nor shall there be any offer, solicitation or sale of the shares in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On May 2, 2023 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat, as well as host investor meetings, at the Bank of America 2023 Health Care Conference on Thursday, May 11, 2023, at 10:40 a.m. PT (1:40 p.m. ET) (Press release, Supernus, MAY 2, 2023, View Source [SID1234630941]).

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The conference will take place May 9-11, 2023, at the Encore Hotel in Las Vegas, Nevada. Investors interested in arranging a meeting with company management should contact the Bank of America conference coordinator. A live audio webcast of the presentation can be accessed here or by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website following the conference.