On February 13, 2023 Sermonix Pharmaceuticals Inc. and Quantum Leap Healthcare Collaborative reported that Sermonix’s investigational next-generation targeted endocrine therapy, lasofoxifene, will be evaluated in a new study arm of the ongoing I-SPY endocrine program sponsored by Quantum Leap (Press release, Sermonix Pharmaceuticals, FEB 13, 2023, View Source [SID1234627121]). This portion of the study targets patients with newly diagnosed estrogen receptor-positive (ER+) invasive cancer.

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The arm is part of the I-SPY 2 Endocrine Optimization Platform (EOP), which is focused on patients with clinically high risk (stage 2/3) estrogen receptor positive (ER+)/HER2- breast cancer, but molecularly low risk (MammaPrint low risk signature). These patients often have substantial risk for recurrence that occurs later (after five years), and thus are in great need of novel agents that are more tolerable and more effective treatments than the current standard of care.

Quantum Leap opened the EOP program in 2021 to specifically address the need for better options for this subset of patients, and to find an early endpoint to measure success of therapy. I-SPY 2 had previously only focused on women with high clinical and molecular risk where complete pathologic response is highly predictive of treatment efficacy.

"Sermonix is delighted to be a part of the truly groundbreaking I-SPY 2 clinical trial, working alongside such esteemed researchers to investigate an area of unmet medical need," said Dr. David Portman, founder and chief executive officer of Sermonix. "To date, we have successfully identified activity from lasofoxifene, and will soon be initiating a Phase 3 registrational trial. It is exciting to be included in I-SPY and potentially generate additional data that could confirm activity of lasofoxifene in early-stage adjuvant settings as well as support differentiated quality-of-life outcomes."

EOP is a sub-study within the main I-SPY-2 clinical trial utilizing neoadjuvant endocrine therapy in patients whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. Lasofoxifene will be evaluated along with other investigational agents in separate study arms as part of the platform trial.

"Lasofoxifene is a novel endocrine treatment that has demonstrated activity in patients with heavily pre-treated ER+/HER2- metastatic breast cancer, including patients harboring tumors with ESR1 mutations," said Dr. Laura Esserman of the University of California San Francisco, founder and leader of the I-SPY Program. "This agent is very well tolerated and thus would be a true advancement for the significant percentage of breast cancer patients who struggle or fail to complete the recommended five years of aromatase inhibitor (AI) therapy."

Dr. Jo Chien, the EOP study’s principal investigator, added: "Lasofoxifene is reported to promote vaginal and sexual health benefits, which are known and challenging side effects of AIs. Should lasofoxifene prove more efficacious and better tolerated than AIs in the neoadjuvant setting, this could have broad implications for both the survival and quality of life for women in the metastatic and early-stage adjuvant settings. Using the I-SPY model, we can accelerate the development of new cancer treatments and target new and innovative treatments to the patients who will benefit most, and we are eager to see data from lasofoxifene-treated subjects in this trial."

In two successfully completed Phase 2 studies (ELAINE-1 and ELAINE-2), lasofoxifene was found to be safe and well tolerated and demonstrated compelling anti-tumor activity, both as monotherapy (ELAINE-1) and in combination with abemaciclib (ELAINE-2). Of particular note, Sermonix shared a case study from ELAINE-1 detailing the first ever known finding of a durable complete response that could be characterized as complete clinical remission in a metastatic estrogen receptor-positive (ER+)/HER2- breast cancer patient with an ESR1 mutation after prior CDK4/6 inhibitor treatment upon participation in any single-agent hormonally based therapy. Additionally, lasofoxifene-treated patients in ELAINE-2 demonstrated mean progression-free survival over 13 months. Full results from the ELAINE-1 and ELAINE-2, which provide strong support for a Phase 3 combination study in 2023, were presented at ESMO (Free ESMO Whitepaper) 2022 and ASCO (Free ASCO Whitepaper) 2022, respectively.

Sermonix will supply lasofoxifene and provide financial support to Quantum Leap for this study. Quantum Leap is sponsor of the I-SPY program, which includes 30 open sites and at least 10 more expected to be added in the first quarter of 2023. All I-SPY sites have the EOP program open.

About Lasofoxifene

Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with abemaciclib in phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.

On February 13, 2023 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will host an Investor Day for institutional investors and financial analysts in New York City on Thursday, March 16, 2023 at the New York Stock Exchange.

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During the event, Jim Davis, CEO and President, Sam Samad, Executive Vice President & CFO, and other senior executives will provide updated views of the U.S. laboratory market, the company’s business strategy, capital deployment priorities, and long-term outlook.

Advance registration is required. To register for the event, please go to: Quest Diagnostics Investor Day 2023 Registration.

A live webcast of the event will be broadcast on the Quest Diagnostics Investor Relations website.

An archived copy of the webcast will be available on the Quest Diagnostics Investor Relations website following the conclusion of the event

On February 13, 2023 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a diversified clinical-stage company developing next generation chemotherapy drugs for patients who have unmet medical conditions and/or require better treatment options to improve a patient’s survival and/or quality of life, reported that it has entered into definitive agreements with retail investors for the purchase and sale of 7,812,544 common shares at a purchase price of $0.80 per share in a registered direct offering priced at the market under the Nasdaq rules (Press release, Processa Pharmaceuticals, FEB 13, 2023, View Source [SID1234627118]). The closing of the offering is expected to occur on or about February 14, 2023, subject to the satisfaction of customary closing conditions.

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Spartan Capital Securities, LLC acted as the sole placement agent for this transaction.

The gross proceeds to the Company from the registered direct offering are expected to be $6.25 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for future clinical trials, research and development expenses, and for working capital and other general corporate purposes.

The shares of common stock are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 previously filed with the Securities and Exchange Commission, or the SEC, and declared effective by the SEC. The offering of the shares of common stock will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, you may contact Wendy Guy for a copy of these documents or contact our principal executive offices at 7380 Coca Cola Drive, Suite 106, Hanover, Maryland, 21076, c/o Wendy Guy, Corporate Secretary, (443) 776-3133.

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

On February 13, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported that it has received a letter from The Nasdaq Stock Market LLC advising the Company that it has regained compliance with Nasdaq’s minimum bid price listing requirement (Press release, Phio Pharmaceuticals, FEB 13, 2023, View Source [SID1234627117]).

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Phio has satisfied the terms of the Nasdaq Listing Qualifications Panel by complying with the minimum bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2), and all other criteria for continued listing. Accordingly, Nasdaq has advised that the matter is now closed.

On February 13, 2023 Morphic Holding, Inc., a Delaware corporation (the "Company"), reported that it has entered into a securities purchase agreement (the "Securities Purchase Agreement") with certain investors listed on the signature pages thereto (the "Investors"), pursuant to which the Company agreed to sell and issue to the Investors in a private placement (the "Private Placement") an aggregate of (i) 848,655 shares (the "Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), at a purchase price of $35.35 per share and (ii) 1,980,198 pre-funded warrants (the "Pre-Funded Warrants") to purchase up to an aggregate of 1,980,198 shares of Common Stock (the "Warrant Shares" and, together with the Shares and the Pre-Funded Warrants, the "Securities") at a purchase price of $35.3499 per Pre-Funded Warrant (Filing, 8-K, Morphic Therapeutic, FEB 13, 2023, View Source [SID1234627116]). Each Pre-Funded Warrant has an exercise price of $0.0001 per Warrant Share. The Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire.

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The Private Placement is anticipated to close on or about February 15, 2023, subject to the satisfaction of customary closing conditions. The Company anticipates receiving gross proceeds from the Private Placement of approximately $100.0 million, before deducting costs and expenses. The Company intends to use the net proceeds from the Private Placement for working capital general corporate purposes, including clinical development.

The Pre-Funded Warrants to be issued in the Private Placement will provide that the holder of the Pre-Funded Warrants will not have the right to exercise any portion of its Pre-Funded Warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to such exercise (the "Beneficial Ownership Limitation").

The foregoing descriptions of the Securities Purchase Agreement and Pre-Funded Warrants do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements, which are filed as Exhibit 10.1 and 4.01, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.

Registration Rights Agreement

In connection with the Private Placement, the Company and the Investors also entered into a Registration Rights Agreement, dated as of February 13, 2023 (the "Registration Rights Agreement"), providing for the registration for resale of the Shares and the Warrant Shares (the "Registerable Securities"). The Company has agreed to prepare and file a registration statement (the "Registration Statement") with the Securities and Exchange Commission (the "SEC") promptly, and in any event within 30 days of the closing of the Private Placement, and to use commercially reasonable efforts to have the Registration Statement declared effective within 30 days (provided that if the Registration Statement is an automatically effective shelf registration statement, or a prospectus supplement to an automatically effective shelf registration statement, it shall become effective upon filing with the SEC pursuant to Rule 462(e)) of the Securities Act of 1933, as amended (the "Securities Act").

The Company has granted the Investors customary indemnification rights in connection with the Registration Rights Agreement. The Investors have also granted the Company customary indemnification rights in connection with the Registration Statement.

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of such agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated by reference herein.

Item 3.02 Unregistered Sales of Equity Securities

The information contained above under Item 1.01, to the extent required by Item 3.02 of Form 8-K, is hereby incorporated by reference herein. Based in part upon the representations of the Investors in the Securities Purchase Agreement, the offering and sale of the Securities was made in reliance on the exemption afforded by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D under the Securities Act and corresponding provisions of state securities or "blue sky" laws. The Securities have not been registered under the Securities Act or any state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from the registration requirements. The sale of the Securities did not involve a public offering and was made without general solicitation or general advertising. The Investors represented that they are accredited investors, as such term is defined in Rule 501(a) of Regulation D under the Securities Act, and that they are acquiring the securities for investment purposes only and not with a view to any resale, distribution or other disposition of the securities in violation of the U.S. federal securities laws.

Neither this Current Report on Form 8-K nor any exhibit attached hereto is an offer to sell or the solicitation of an offer to buy shares of Common Stock or other securities of the Company

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year

On February 12, 2023, in connection with the effectiveness of new SEC rules regarding universal proxy cards, certain recent changes to the Delaware General Corporation Law (the "DGCL"), and a periodic review of the bylaws of the Company, the Company’s board of directors (the "Board") approved and adopted the Company’s amended and restated bylaws (the "Amended and Restated Bylaws"), which became immediately effective.

Among other things, the amendments effected by the Amended and Restated Bylaws:

· revise certain provisions relating to adjournment procedures and lists of stockholders entitled to vote at stockholder meetings, in each case to conform to recent amendments to the DGCL;
· update certain provisions related to the conduct of stockholder meetings, including clarifying that the presiding person of a stockholder meeting may set additional attendance or other procedures for meeting attendees and Rule 14a-8 proponents;
· revise the procedures and disclosure requirements set forth in the advance notice bylaw provisions, including (1) requiring additional information, representations and disclosures from proposing stockholders, proposed nominees and other persons related to a stockholder’s solicitation of proxies, (2) restricting the number of nominees a stockholder may nominate for election at a meeting to the number of directors to be elected at such meeting, (3) requiring that proposed nominees be available for interviews by the Board or any Board committee thereof;
· address matters relating to Rule 14a-19 under the Securities Exchange Act of 1934, as amended (the "Universal Proxy Rules") (e.g., providing that stockholders delivering a notice of nomination certify to the Company in writing that they have complied with the Universal Proxy Rules requirements, providing the Company a remedy if a stockholder fails to satisfy the Universal Proxy Rules requirements, requiring that a stockholder providing notice pursuant to the advance notice bylaws to inform the Company if a stockholder no longer plans to solicit proxies in accordance with the Universal Proxy Rules, and requiring stockholders intending to use the Universal Proxy Rules to provide reasonable evidence of the satisfaction of the requirements under the Universal Proxy Rules at least five business days before the meeting, etc.);
· require that a stockholder directly or indirectly soliciting proxies from other stockholders use a proxy card color other than white;

· require that a stockholder intending to authorize a qualified representative to act for such stockholder as a proxy to present a nomination or proposal at such meeting to give notice of such authorization to the Company at least three business days before the applicable meeting;
· amend the notice provisions to reflect amendments to the DGCL relating to electronic transmission of notices to stockholders; and
· add an emergency bylaw provision to provide clarity and authority to directors and certain officers during an emergency situation that would otherwise prevent a quorum of the Board or a Board committee from being achieved.

The Amended and Restated Bylaws also incorporate ministerial, clarifying and conforming changes, including changes to align with the language used in certain provisions of the DGCL and the Universal Proxy Rules.

The foregoing summary does not purport to be complete and is qualified in its entirety by reference to the full text of the Amended and Restated Bylaws, a copy of which is attached hereto as Exhibit 3.1 and is incorporated herein by reference.