On December 23, 2022 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 that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series D Preferred Stock, par value $0.001 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Standard Time on January 3, 2023 (Press release, Soligenix, DEC 23, 2022, View Source [SID1234625579]). The shares of Series D Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Standard Time on January 4, 2023. The outstanding shares of Series D Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a reverse stock split, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the reverse stock split, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series D Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series D Preferred Stock).

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"The current market conditions have been extremely difficult for many companies both large and small, and Soligenix is no exception," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "After receiving the Nasdaq deficiency letter stating that the Company no longer met the required $1.00 minimum bid price, we were hopeful that our important 2022 milestones such as the submission of the HyBryte new drug application (NDA), had the potential to put the Company back in compliance with Nasdaq requirements. Unfortunately, while achieving these major milestones, our stock price did not respond as we had hoped in these difficult global market conditions. Therefore, we are now faced with having to consider a reverse stock split in order to maintain our Nasdaq listing, which is very important for the Company’s future success as we move toward potential NDA approval and U.S. launch, and continue partnership discussions. It should also make our stock more attractive to larger institutional investors."

All shares of Series D Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the reverse stock split as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series D Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by the Company’s Board of Directors or automatically upon the approval by the Company’s stockholders of an amendment to the Company’s certificate of incorporation effecting the reverse stock split at such meeting.

The Series D Preferred Stock will be uncertificated, and no shares of Series D Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series D Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.

Further details regarding the Series D Preferred Stock will be contained in a report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.

On December 23, 2022, Sesen Bio, Inc. ("Sesen") and Viventia Bio, Inc., a wholly-owned subsidiary of Sesen ("Viventia," and together with Sesen, the "Company"), terminated the Exclusive License Agreement (the "License Agreement") dated July 30, 2020 by and between Sesen, Viventia, and Qilu Pharmaceutical Co., Ltd. ("Qilu"), as well as other related agreements between the Company and Qilu, consistent with the Company’s previously disclosed restructuring plan (Filing, 8-K, Sesen Bio, DEC 23, 2022, View Source [SID1234625578]). The terms of the License Agreement are more fully described in the Company’s Form 8-K filed with the Securities and Exchange Commission on July 31, 2020.

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In connection with the termination of the License Agreement, the Company shall make a one-time aggregate payment to Qilu of $1,400,000, which consists of a $1,200,000 termination fee payable upon the termination of the License Agreement and a $200,000 payment payable upon the Company’s receipt of certain clinical data and chemistry, manufacturing, and controls data from Qilu. As a result of the termination of the License Agreement, all rights to Vicineum in China, Hong Kong, Macau and Taiwan have reverted to the Company. The Company currently retains all global rights to Vicineum and is continuing to work with a financial advisor to explore strategic alternatives for Vicineum to maximize value for Sesen Bio stockholders.

As previously reported, Sangamo Therapeutics, Inc. (the "Company") is a party to the Open Market Sale Agreement℠, dated August 5, 2020 (the "Original Sales Agreement"), between the Company and Jefferies LLC ("Jefferies"), as amended by Amendment No. 1, dated May 5, 2021 ("Amendment No. 1" and, together with the Original Sales Agreement, the "Sales Agreement") (Filing, 8-K, Sangamo Therapeutics, DEC 23, 2022, View Source [SID1234625577]). Under the Sales Agreement, the Company may offer and sell, from time to time, through Jefferies as its sales agent or principal, shares of its common stock, par value $0.01 per share (the "Common Stock"), having an aggregate offering amount of up to $150 million (the "Initial Shares"). As of the date hereof, the Company had offered and sold Initial Shares with an aggregate offering amount of approximately $115 million pursuant to the Sales Agreement.

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On December 23, 2022, the Company and Jefferies entered into Amendment No. 2 to the Sales Agreement ("Amendment No. 2" and, together with the Sales Agreement, the "Amended Sales Agreement") to provide for an increase in the aggregate offering amount under the Sales Agreement such that the Company may offer and sell additional shares of Common Stock having an aggregate offering amount of up to $175 million (the "Additional Shares" and, together with the "Initial Shares," the "Shares") under the Amended Sales Agreement. The terms and conditions of the Sales Agreement otherwise remain unchanged.

The Company is not obligated to sell any Shares under the Amended Sales Agreement. Subject to the terms and conditions of the Amended Sales Agreement, Jefferies will use commercially reasonable efforts, consistent with its normal trading and sales practices and applicable laws and regulations, to sell Shares from time to time based upon the Company’s instructions, including any price, time or size limits or other customary parameters or conditions the Company may specify, subject to certain limitations. Under the Amended Sales Agreement, Jefferies may sell Shares by any method permitted by law deemed to be an "at-the-market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended.

The issuance and sale, if any, of Shares under the Amended Sales Agreement will be made pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-255792), filed with the Securities and Exchange Commission (the "SEC") on May 5, 2021. The offering of the Shares is described in the Company’s Prospectus dated May 5, 2021, as supplemented by a Prospectus dated May 5, 2021 and filed with the SEC on May 5, 2021, and a Prospectus Supplement dated December 23, 2022 and filed with the SEC on December 23, 2022. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any Shares under the Amended Sales Agreement nor shall there be any offer, solicitation or sale of such Shares 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.
Cooley LLP, counsel to the Company, has issued a legal opinion relating to the validity of the Additional Shares. A copy of such legal opinion, including the consent included therein, is filed as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The foregoing description of the material terms of Amendment No. 2 is qualified in its entirety by reference to the full texts of (i) the Original Sales Agreement, a copy of which was filed as Exhibit 1.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 5, 2020, (ii) Amendment No. 1, a copy of which was filed as Exhibit 1.3 to the Company’s Registration Statement on Form S-3 filed with the SEC on May 5, 2021, and (iii) Amendment No. 2, which is attached as Exhibit 1.1 to this Current Report on Form 8-K, each of which is incorporated herein by reference.

On December 23, 2022 Regeneron Pharmaceuticals (NASDAQ: REGN) reported that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Libtayo (cemiplimab) as monotherapy to treat patients with advanced or recurrent cervical cancer whose disease progressed after chemotherapy (Press release, Regeneron, DEC 23, 2022, View Source [SID1234625576]).

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"In recent years, the incidence of cervical cancer has increased in Japan, with the prognosis for advanced stage disease remaining poor and treatment options limited," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "With this approval, Libtayo becomes the first single-agent immunotherapy approved in Japan for the treatment of advanced cervical cancer."

The MHLW approval is based on positive data from the international, multicenter Phase 3 EMPOWER-Cervical 1 trial, conducted in collaboration with NRG Oncology-Japan, the GOG Foundation, Inc., and the European Network for Gynaecological Oncological Trial (ENGOT) groups. The trial evaluated Libtayo compared to an investigator’s choice of chemotherapy and enrolled 608 patients across 14 countries, including Japan, irrespective of PD-L1 expression status or histology. In March 2021, the trial was stopped early based on the highly significant effect of Libtayo on overall survival among squamous cell carcinoma patients following a unanimous recommendation by the Independent Data Monitoring Committee.

"With Libtayo, Japan now has an approved treatment option that has demonstrated significant survival benefits in this cervical cancer patient population compared to chemotherapy irrespective of PD-L1 expression – a milestone no other PD-1 inhibitor has achieved in a Phase 3 trial," said Prof. Kosei Hasegawa, Gynecologic Oncology, Saitama Medical University International medical Center, a trial investigator and a member of NRG Oncology-Japan. "We are proud to have contributed to bringing this new treatment option to women living with this difficult-to-treat cancer in Japan.

Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed in women between the ages of 35 and 44. Almost all cases of cervical cancer are caused by human papillomavirus (HPV) infection. It is estimated that approximately 600,000 new cases of cervical cancer are diagnosed and 350,000 deaths from cervical cancer occur worldwide each year.

In November 2022, Libtayo was approved by the European Commission for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron’s proprietary VelocImmune technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced CSCC and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in Japan, the European Union, Canada and Brazil.

Libtayo was jointly developed by Sanofi and Regeneron under a global collaboration agreement. As of July 1, 2022, Regeneron is responsible for the development and marketing of Libtayo globally. In Japan, Libtayo is currently marketed by Sanofi on Regeneron’s behalf over the course of a defined transition period.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat:

— People with a type of skin cancer called CSCC that has spread or cannot be cured by surgery or radiation.

— People with a type of skin cancer called BCC:

That cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with an HHI.
That has spread (metastatic BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
— Adults with a type of lung cancer called NSCLC:

Libtayo may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, OR your lung cancer has spread to other areas of your body (metastatic lung cancer), AND your tumor does not have an abnormal "EGFR", "ALK" or "ROS1" gene.
Libtayo may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, OR your lung cancer has spread to other areas of your body (metastatic lung cancer), AND your tumor tests positive for high "PD-L1", AND your tumor does not have an abnormal "EGFR", "ALK "or "ROS1" gene.
It is not known if Libtayo is safe and effective in children.

IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS

What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat certain cancers by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, or chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Libtayo. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Libtayo. Your healthcare provider will monitor you for these complications
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Libtayo if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

— have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus

— have received an organ transplant

— have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)

— have received radiation treatment to your chest area

— have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome

— are pregnant or plan to become pregnant. Libtayo can harm your unborn baby

Females who are able to become pregnant:

Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
— are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo when used alone include muscle or bone pain, tiredness, rash, and diarrhea. The most common side effects of Libtayo when used in combination with platinum-containing chemotherapy include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, decreased appetite. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296.

On December 23, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported that it has entered into securities purchase agreements with existing institutional and accredited investors for the purchase and sale of 28,460,831 shares of common stock at a purchase price of $0.8784 per share in a registered direct offering priced at-the-market under Nasdaq rules, resulting in aggregate gross proceeds of approximately $25.0 million (Press release, Outlook Therapeutics, DEC 23, 2022, View Source [SID1234625575]). The offering included participation by GMS Ventures and Investments, Outlook Therapeutics’ largest stockholder. The offering is expected to close on December 28, 2022, subject to customary closing conditions.

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M.S. Howells & Co. acted as placement agent with respect to certain accredited investors in the offering. BTIG, LLC acted as exclusive financial advisor to Outlook Therapeutics in connection with the offering. BTIG, LLC is not acting as an underwriter or a placement agent in connection with the offering and, accordingly, BTIG, LLC is neither purchasing securities nor offering securities to the public in connection with the offering.

Outlook Therapeutics intends to use the net proceeds from the offering for support of its ONS-5010 development program as well as working capital and other general corporate purposes, which may include the repayment of debt.

The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 (Registration No. 333-254778), including a base prospectus, previously filed with the Securities and Exchange Commission ("SEC") on March 26, 2021 and declared effective by the SEC on April 1, 2021. The offering is being made only by means of a prospectus, including a prospectus supplement, that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source