On August 9, 2024 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended June 30, 2024 (Press release, Soligenix, AUG 9, 2024, View Source [SID1234645693]).

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"This is a pivotal time for Soligenix with a great deal of clinical activity and upcoming milestones," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "While we prepare for the upcoming initiation of our confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease, we are incredibly encouraged by the recent positive clinical results from our comparability study evaluating HyBryte against Valchlor (mechlorethamine gel), which demonstrated a three-fold higher response rate over a 12-week treatment period and more favorable safety profile for HyBryte in the treatment of CTCL. These findings, coupled with the promising interim data from the ongoing open-label, investigator-initiated study evaluating extended HyBryte treatment, reinforce our excitement about the future of HyBryte as a potential front-line treatment option for patients with early-stage CTCL. Additionally, we will be initiating a Phase 2 study with SGX945 (dusquetide) in Behçet’s disease later this year with top-line results expected in the first half of 2025, along with top-line results expected during the same timeframe from our ongoing SGX302 (synthetic hypericin) Phase 2 study in mild-to-moderate psoriasis."

Dr. Schaber continued, "With approximately $9.1 million in cash at June 30, 2024, exclusive of the approximately $4.1 million in net proceeds from recent warrant exercises, we continue to prioritize resource allocation to achieve our goals. We have a clear vision for the future, and we are actively pursuing strategies to create long-term value for our shareholders, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On July 24, 2024, the Company received a letter from Nasdaq confirming that the Company had regained compliance with the Minimum Bid Price Rule. Accordingly, the Nasdaq Hearings Panel determined to continue the listing of the Company’s common stock and closed the matter.
On July 9, 2024, the Company announced an interim update on the open-label, investigator-initiated study evaluating extended HyBryte treatment for up to 12 months in patients with early-stage CTCL. To view this press release, please click here.
On June 25, 2024, the Company announced positive clinical results from a comparability study evaluating HyBryte versus Valchlor in the treatment of CTCL. To view this press release, please click here.
On May 16, 2024, the Company announced the publication of results of its compatibility study evaluating HyBryte for the treatment of CTCL in the Journal of the European Academy of Dermatology & Venereology (JEADV) Clinical Practice. To view the publication, please click here. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2024

Soligenix’s revenues for the quarter ended June 30, 2024 were less than $0.1 million as compared to $0.2 million for the quarter ended June 30, 2023. Revenues primarily relate to government contracts and grants awarded in support of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; development of CiVax, our vaccine candidate for the prevention of COVID-19, and evaluation of HyBryte for expanded treatment in patients with early-stage CTCL.

Soligenix’s net loss was $1.6 million, or ($1.31) per share, for the quarter ended June 30, 2024, as compared to $1.6 million, or ($3.56) per share, for the quarter ended June 30, 2023. The increase in net loss was primarily due to decreases in gross profit and tax credits as well as an increase in operating expenses, offset by increases in interest income and changes in the fair value of debt during the three months ended June 30, 2024.

Research and development expenses were $0.5 million as compared to $0.8 million for the quarters ended June 30, 2024 and 2023, respectively. The decrease was primarily due to adjustment of estimated accruals for completed clinical trials offset by preliminary costs associated with the anticipated initiation of our Phase 2 study in Behçet’s Disease and the second Phase 3 CTCL trial.

General and administrative expenses were $1.2 million and $0.9 million for the quarters ended June 30, 2024 and 2023, respectively. The increase in general and administrative expenses for the three months ended June 30, 2024 was primarily attributable to an increase in legal and professional fees associated with the 2024 annual meeting of stockholders, the April 2024 public offering and the June 2024 reverse stock split of our issued and outstanding shares of common stock.

As of June 30, 2024, the Company’s cash position, exclusive of the approximately $4.1 million in net proceeds from recent warrant exercises, was approximately $9.1 million.

On August 9, 2024 Scorpius Holdings, Inc. (NYSE American: SCPX), ("Scorpius", or the "Company"), an integrated contract development and manufacturing organization (CDMO), reported a delay in its previously announced public offering (Press release, Scorpius BioManufacturing, AUG 9, 2024, View Source [SID1234645687]). The Company has requested, and the NYSE has approved, a financial viability exception to the NYSE American shareholder approval rules that would allow it to proceed with the closing of an underwritten public offering. The Company intends to pursue the sale of 12,500,000 shares of common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof, exclusive of the over-allotment option) at a price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). The underwriting agreement was terminated in connection with the previously announced offering and a new underwriting agreement will be entered into if the offering is consummated. There can be no assurance that the Company will be able to consummate an offering under these terms or otherwise. The Company will adhere to all applicable provisions relating to the exemption, as outlined in Section 710 of the NYSE American Company Guide, and a closing is intended to occur ten days following the mailing of a notification letter to the Company’s shareholders.

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The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.

ThinkEquity is acting as sole book-running manager for the offering.

A registration statement on Form S-1 (File No. 333-280887), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

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

On August 9, 2024 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical­stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, reported second quarter 2024 financial results and summarized recent developments (Press release, Monopar Therapeutics, AUG 9, 2024, View Source [SID1234645679]).

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Recent Developments

MNPR­101 for Radiopharmaceutical Use

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MNPR­101 is a uPAR-targeting antibody being developed as a precision radiopharmaceutical for both imaging and treatment of various cancers.

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MNPR-101-Zr is a cancer imaging agent radiolabeled with Zirconium-89, a positron emission tomography (PET) imaging isotope. Preclinical imaging studies have shown selective, high, and enduring tumor uptake across multiple uPAR-expressing cancers including pancreatic, colorectal, and triple negative breast cancers. An open-label Phase 1 imaging and dosimetry clinical trial of MNPR-101-Zr was recently initiated and is currently active and enrolling patients.

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An open-label Phase 1 clinical trial for Monopar’s therapeutic radiopharmaceutical MNPR-101-RIT is on track to initiate as early as Q4 2024. Preclinical in vivo studies of therapeutic radioisotopes, such as actinium-225 and lutetium-177, bound to MNPR-101 have shown near complete elimination of uPAR-expressing tumors after just a single injection.

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Monopar’s MNPR-101-RIT abstract was selected as a Top-Rated Oral Presentation at the European Association of Nuclear Medicine (EANM) 2024 Annual Congress that will be held in Hamburg, Germany in October 2024.
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A long-term supply agreement with NorthStar Medical Radioisotopes LLC was entered into under which NorthStar agreed to provide actinium-225 for Monopar’s development stage and potential future commercial stage programs.

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The NorthStar collaboration agreement was amended, with one primary impact being Monopar gaining full ownership and title to its lead MNPR-101 radiopharmaceutical platform.

Reverse Stock Split

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On August 5, 2024, the stockholders approved the reverse stock split proposal at the Annual Meeting of Stockholders, which provided the Board of Directors with authority to effect a reverse split within the range of ratios approved by stockholders. Subsequently, the Board of Directors approved a reverse stock split of 1 for 5 shares of the Company’s common stock in an attempt to regain compliance with the Nasdaq’s continued listing requirements. The Company expects that the reverse stock split will become effective at 5:00 pm on Monday August 12, 2024, and its common stock will begin trading on a split-adjusted basis at the open of trading on Tuesday, August 13, 2024.

Results for the Second Quarter Ended June 30, 2024 Compared to the Second Quarter Ended June 30, 2023

Cash and Net Loss

Cash, cash equivalents and short-term investments as of June 30, 2024, were $7.1 million. Monopar projects that its current funds will be sufficient to continue operations at least through August 31, 2025, including to continue to conduct and conclude our first-in-human clinical trial with our MNPR-101-Zr radiopharmaceutical imaging program and to advance our MNPR-101-RIT program into the clinic. We are in the process of winding down the camsirubicin Phase 1b clinical trial and the preclinical development of MNPR-202 due to focusing our finite financial resources on our radiopharmaceutical programs. We will require additional funding to further advance our clinical and preclinical programs, and we anticipate that we will seek to raise additional capital within the next 12 months to fund our future operations.

Net loss for the second quarter of 2024 was $1.7 million, or $0.10 per share, compared to net loss of $2.2 million, or $0.16 per share, for the second quarter of 2023.

Research and Development (R&D) Expenses

R&D expenses for the quarter ended June 30, 2024 were $1,131,000, compared to $1,595,000 for the quarter ended June 30, 2023. This represents a decrease of $464,000 attributed to (1) a decrease of $636,000 in Validive clinical trial-related expenses due to the closure of the trial in March 2023, and (2) decrease in camsirubicin manufacturing costs of $138,000. These decreases were partially offset by a net increase of $310,000 due to other R&D expenses attributable to MNPR-101 for radiopharma use.

General and Administrative (G&A) Expenses

G&A expenses for the quarter ended June 30, 2024 were $658,000, compared to $733,000 for the quarter ended June 30, 2023. This represents a decrease of $75,000 primarily attributed to (1) a decrease in stock-based compensation to the board of directors of $64,000 as no equity awards were issued to the board of directors to-date in 2024, and (2) a net decrease in consulting, tax services and other G&A expenses of $11,000.

Principal Effects of the Pending Reverse Stock Split

The number of shares authorized remains at 40,000,000. After effectiveness of the anticipated reverse stock split, the unaudited proforma number of shares issued and outstanding will be approximately 3,520,366. The par value will remain unchanged at $0.001 per share.

On August 9, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, reported that it will effect a 1-for-5 reverse stock split of its outstanding shares of common stock (the "Reverse Stock Split") (Press release, Monopar Therapeutics, AUG 9, 2024, View Source [SID1234645678]). The Company expects that the Reverse Stock Split will become effective at 5:00 pm on Monday August 12, 2024, and its common stock will begin trading on a split-adjusted basis at the open of trading on Tuesday, August 13, 2024 under the new CUSIP number 61023L207. Monopar’s common stock will continue to trade on the NASDAQ Capital Market under the symbol "MNPR". The Reverse Stock Split is an effort to regain compliance with Nasdaq’s listing rules.

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The Reverse Stock Split was approved by the Company’s stockholders at its Annual Meeting of Stockholders held on August 5, 2024, to be effected by the Company’s Board of Directors within approved parameters. The Company’s Board of Directors approved the Reverse Stock Split at a ratio of 1-for-5 on August 5, 2024.

As a result of the Reverse Stock Split, each 5 shares of the Company’s issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock, resulting in the number of outstanding shares of Monopar’s common stock being reduced from approximately 17.6 million to approximately 3.5 million immediately following the effectiveness of the Reverse Stock Split. The Reverse Stock Split will affect all holders of shares of our common stock uniformly and each stockholder will hold the same percentage of our common stock outstanding immediately following the reverse stock split as that stockholder held immediately prior to the reverse stock split, except for adjustments that may result from the treatment of fractional shares as described below. The Reverse Stock Split will not affect the number of authorized shares of common stock or the par value of the common stock.

Monopar’s transfer agent, VStock Transfer LLC, which is also acting as the exchange agent for the Reverse Stock Split, will provide instructions to stockholders regarding the process for exchanging physical share certificates. Stockholders holding their shares in book-entry form will not need to take any action in connection with the Reverse Stock Split. Stockholders will not receive fractional shares of common stock in connection with the Reverse Stock Split. Instead, stockholders who would have been entitled to a fractional share will receive such additional fraction of a share of common stock as is necessary to increase the fractional share to which they were entitled to a full share.

Additional information on the Reverse Stock Split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on July 22, 2024, which is available on the SEC’s website at www.sec.gov and on the Company’s website, www.monopartx.com.

On August 9, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Curon Biopharmaceutical (Curon), a privately held biotechnology company, reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire CN201, a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases (Press release, Merck & Co, AUG 9, 2024, View Source [SID1234645677]).

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"We continue to identify opportunities to expand and diversify our pipeline," said Dr. Dean Y. Li, president, Merck Research Laboratories. "Early clinical data have provided robust evidence for the potential of CN201 to target and deplete circulating and tissue B cells with the potential to treat a range of malignant and autoimmune diseases."

Under the terms of the agreement, Merck through a subsidiary will acquire full global rights to CN201 for an upfront payment of $700 million in cash. Curon is also eligible to receive up to $600 million in milestone payments associated with the development and regulatory approval of CN201.

CN201 is currently being evaluated in Phase 1 and Phase 1b/2 clinical trials for the treatment of patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and relapsed or refractory B-cell acute lymphocytic leukemia (ALL), respectively. Preliminary data suggest CN201 has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well tolerated, with the potential to induce significant and sustained reductions in B-cell populations. Merck plans to evaluate CN201 as a treatment for B-cell malignancies as well as investigate its potential to provide a novel, scalable option for the treatment of autoimmune diseases.

"This agreement reflects the drive and dedication of the Curon team," said Zhihong Chen, president and chief executive officer, Curon. "As a pioneer in immuno-oncology, Merck is well positioned to build upon the work done to-date and investigate the wide-ranging, first-in-class potential of CN201."

Closing of the proposed transaction is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the third quarter of 2024 and be accounted for as an asset acquisition. Merck expects to record a pre-tax charge of approximately $750 million (reflecting the upfront payment and other related costs), or approximately $0.28 per share, to be included in non-GAAP results in the quarter that the transaction closes. As a matter of policy, Merck provides updates to its financial outlook once each quarter and will provide an update to its full-year financial outlook when it reports third-quarter 2024 results.

Advisors
Hogan Lovells is serving as Merck’s legal advisor in this transaction. Centerview Partners LLC acted as financial advisor to Curon and Goodwin Procter LLP as the company’s legal advisor.

About CN201
CN201 is a novel CD3xCD19-targeting T-cell-engager bispecific antibody, designed to target B cells for elimination by T cells. CN201 is currently being evaluated in Phase 1 and Phase 1b/2 clinical trials for the treatment of relapsed or refractory non-Hodgkin’s lymphoma and relapsed or refractory acute lymphocytic leukemia, respectively.