Perimeter Medical Imaging AI Announces Closing of Strategic Private Placement to Social Capital

On January 27, 2022 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported the closing of its previously announced private placement of units (each, a "Unit") for gross proceeds of C$48.7 million to the Company (the "Private Placement") (Press release, Perimeter Medical Imaging AI, JAN 27, 2022, View Source [SID1234607453]). The Private Placement included the C$43.4 million strategic investment in the Company (the "Investment") by Social Capital.

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Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "We are extremely excited to have completed this transformative, pivotal event for Perimeter and to welcome Social Capital as a shareholder of Perimeter. This strategic partnering with Social Capital comes at a time when we are ramping up our Perimeter S-Series market development activities and commercialization efforts across the U.S., while also supporting the ongoing clinical development of our next-gen AI technologies. We are very optimistic that the Private Placement will allow the Company to unlock additional growth and potential and we thank Social Capital for its support and endorsement of our vision to transform cancer surgery with ultra-high resolution, real-time, advanced imaging tools."

Chamath Palihapitiya, founder and CEO of Social Capital, said, "Perimeter has the opportunity to change how we approach removing cancerous tumors from the body. Starting with breast cancer, Perimeter’s OCT technology can potentially eliminate the need for a second or sometimes even third surgery because not all of the cancer was removed the first time – a risk faced by 1 in 4 breast cancer patients in America today. Over time, we hope Perimeter can apply this technology to a range of other tumor removal surgeries. We are excited to begin this partnership with Jeremy and his team to raise the standard of care for cancer patients."

Details Regarding the Private Placement

The Private Placement was completed on a non-brokered basis for gross proceeds of C$48.7 million at a price of C$3.00 per Unit for a total of 16,234,333 Units. Each Unit consisted of one common share (each, a "Common Share") and a total of one warrant ("Warrant") to purchase an additional Common Share (a "Warrant Share"). 80% of the Warrants issued in the Private Placement have a strike price of C$3.99 and 20% of the Warrants issued in the Private Placement have a strike price of C$4.50. Half of the Warrants at each strike price are subject to accelerated expiry if the 60-day volume weighted average trading price of Perimeter’s Common Shares is greater than the strike price during the applicable period. The other half of the Warrants are not subject to accelerated expiry, and instead they may be exercised for cash or exercised using a cashless exercise feature at any time prior to expiry. Subject to the accelerated expiry clause described above, all Warrants will expire five years following the closing of the Private Placement.

As the result of its C$43.4 million Investment, Social Capital acquired 14,466,667 Common Shares and 14,466,664 Warrants. Social Capital and Perimeter have also entered into an investor rights agreement whereby Social Capital will have the right to nominate one director to the board of Perimeter, as well as anti-dilution rights to participate in future financings, and customary registration rights. Social Capital’s board nomination and anti-dilution rights under the investor rights agreement will last so long as Social Capital holds at least 15% of the Common Shares of Perimeter on an undiluted basis, and Social Capital’s registration rights will last so long as Social Capital holds at least 10% of the Common Shares of Perimeter on an undiluted basis.

On a non-diluted basis, Social Capital now holds approximately 23.3% of the outstanding Common Shares making Social Capital a "Control Person" (as that term is defined in the policies of the TSX Venture Exchange (the "TSXV")) of Perimeter. The Investment by Social Capital was consented to in writing by shareholders of Perimeter holding greater than 50% of Perimeter’s outstanding Common Shares at the time the Private Placement was announced, including Roadmap Capital Inc., Perimeter’s largest shareholder, which entered into a support agreement in favour of the Private Placement at the time the Private Placement was announced.

In addition to the Investment by Social Capital, the Company issued an additional 1,767,666 Units to other investors for gross proceeds of C$5.3 million (resulting in aggregate gross proceeds of C$48.7 million).

The net proceeds of the Private Placement will be used for working capital, commercialization of Perimeter’s technology, clinical studies and the further development of Perimeter’s technology, and general corporate purposes.

All Common Shares and Warrants issued pursuant to the Private Placement will be subject to a statutory hold period of four months plus one day which expires on May 27, 2022.

In connection with the Closing of the Private Placement, the Company paid a finder’s fee equal to 3% of the proceeds from the sale of Units to Social Capital by issuing 434,000 Common Shares (the "Finder’s Shares") at a deemed price of $3.00 per Common Share. The Company also paid finder’s fees equal to 6% of the proceeds from the sale Units to certain investors introduced to Perimeter by other finders by paying cash in the amount of C$197,399.88.

The Common Shares comprising part of the Units, the Warrants and the Warrant Shares (if such Warrant Shares are issued before the date that is four months and one day following the applicable Closing Date) and the Finder’s Shares shall be subject to a hold period ending on the date that is four months and one day following the applicable Closing Date.

Insider Participation in the Private Placement

Jeremy Sobotta, Chief Executive Officer; Tom Boon, Chief Operating Officer; Andrew Berkeley, Vice President, Business Development; Aaron Davidson, Director; and Suzanne Foster, Director participated in the Private Placement, thereby making the Private Placement a "related party transaction" as defined under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101"). Mr. Sobotta subscribed for 10,000 Units, Mr. Boon subscribed for 5,000 Units, Mr. Berkeley subscribed for 6,000 Units, Mr. Davidson subscribed for 84,000 Units and Ms. Foster subscribed for 42,000 Units.

Each Common Share of Perimeter provides the holder with the right to one vote per common share. The Private Placement was unanimously approved by the directors of Perimeter and consented to by shareholders of Perimeter holding approximately 50.8% of Perimeter’s outstanding Common Shares at the time the Private Placement was announced.

Other than the subscription agreements between Mr. Sobotta, , Mr. Boon, Mr. Berkeley, Mr. Davidson and Ms. Foster relating to the issuance of the Units pursuant to the Private Placement, Perimeter has not entered into any agreement with an interested party or a joint actor with an interested party in connection with the Private Placement.

The Private Placement was exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as the Private Placement was a distribution of securities for cash and neither the fair market value of the Shares distributed to, nor the consideration received from, interested parties exceeded $2,500,000. Neither Perimeter, nor to the knowledge of Perimeter after reasonable inquiry, a related party, has knowledge of any material information concerning Perimeter or its securities that has not been generally disclosed. The material change report in connection with the Private Placement was not filed 21 days in advance of the closing of the Private Placement for the purposes of Section 5.2(2) of MI 61-101 on the basis that the subscriptions under the Private Placement were not available to Perimeter until shortly before the closing.

Early Warning Disclosure as a Result of Completion of the Investment

Pursuant to the Investment, Social Capital acquired 14,466,667 Common Shares and 14,466,664 Warrants. Prior to the completion of the Investment Social Capital did not own any Common Shares. On a non-diluted basis, Social Capital has increased its ownership of Common Shares from 0% to approximately 23.2%. On a partially-diluted basis, assuming exercise of the Warrants held by Social Capital, Social Capital exercises control over 28,933,331 (approximately 37.7%) of the issued and outstanding Common Shares.

As noted above, the Common Shares comprising part of the Units, the Warrants and the shares underlying the Warrants (if such shares are issued before the date that is four months and one day following the applicable closing date) held by Social Capital are subject to a four month plus one day hold period which expires on May 27, 2022.

Social Capital has acquired the Common Shares and Warrants for investment purposes.

The foregoing disclosure is being disseminated pursuant to National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting. A copy of the report to be filed with Canadian securities regulators in connection with the acquisition of these securities will be available on Perimeter’s SEDAR profile at www.sedar.com and a copy may be obtained by contacting Perimeter as noted under "Contact" below.

Preclinical Data Show Potential for Use of Genprex’s ONCOPREX® Nanoparticle Delivery System in Treating Colon Cancer

On January 27, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its collaborators published positive preclinical data for the use of Genprex’s ONCOPREX Nanoparticle Delivery System for delivery of a FAS DNA plasmid to treat metastatic colorectal cancer. Published in the journal Cancers1, the preclinical study found that tumor selective ONCOPREX nanoparticles carrying FAS DNA plasmids suppress human colon tumor growth in vivo in mouse models, indicating that this may be an effective therapy for human colorectal cancer (Press release, Genprex, JAN 27, 2022, View Source [SID1234607437]).

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The manuscript, "Restoring FAS Expression via Lipid-Encapsulated FAS DNA Nanoparticle Delivery Is Sufficient to Suppress Colon Tumor Growth In Vivo," provides data indicating that complete loss of FAS expression is often observed in metastatic human colorectal tumors. Using Genprex’s ONCOPREX system to deliver the FAS gene, the researchers found that overexpression of codon usage-optimized FAS in metastatic mouse colon-tumor cells enabled FASL-induced elimination of FAS positive tumor cells in vitro, suppressed colon tumor growth, and increased the survival of tumor-bearing mice in vivo.

"These positive preclinical data validate that the ONCOPREX Nanoparticle Delivery System can be used to deliver tumor suppressor genes other than TUSC2, which we are using in lung cancer studies with REQORSA, to address multiple types of cancer," said Mark S. Berger, MD, Chief Medical Officer at Genprex. "The data also provide early support for FAS as a tumor suppressor gene in colorectal cancer. With this compelling data, Genprex is positioned to expand its oncology programs in the future and to further explore use of its delivery system for other therapeutic genes, alone or in combination with other approved cancer therapies, to provide new therapeutic approaches for patients with serious medical conditions and unmet medical needs. We will continue to evaluate FAS using our ONCOPREX delivery platform as a potential pipeline addition within our oncology program."

Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in humans.

The ONCOPREX delivery system is used to deliver TUSC2 plasmid DNA in Genprex’s REQORSA immunogene therapy. REQORSA is being combined with Tagrisso (by AstraZeneca) in the Company’s Acclaim-1 clinical trial and is being combined with Keytruda (by Merck & Co.) in the Company’s Acclaim-2 clinical trial, both targeting progressing lung cancers.

In 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for REQORSA for non-small cell lung cancer (NSCLC) in combination therapy with Tagrisso (osimertinib) for late-stage patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA for NSCLC in combination therapy with Keytruda (pembrolizumab) for late-stage patients whose disease progressed after treatment with Keytruda.

The ONCOPREX Nanoparticle Delivery System is designed to deliver tumor suppressor genes, which are encapsulated in lipid nanoparticles. The nanoparticles are then administered intravenously and taken up by tumor cells where the encapsulated gene is translated to express proteins that are missing or depleted in cancer cells. Genprex has treated more than 50 NSCLC patients in clinical trials with REQORSA, the Company’s lead drug candidate that uses the ONCOPREX Nanoparticle Delivery System to deliver the TUSC2 gene.

A Phase 1 clinical trial showed that systemic, intravenous therapy using the ONCOPREX Nanoparticle Delivery System was shown to selectively and preferentially target tumor cells, resulting in clinically significant anticancer activity. The nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and providing extended half-life in the circulation.

1Cancers 2022, 14(2), 361; View Source

McKesson Declares Quarterly Dividend

On January 27, 2022 The Board of Directors of McKesson Corporation (NYSE:MCK) reported that declared a regular dividend of 47 cents per share of common stock (Press release, McKesson, JAN 27, 2022, View Source [SID1234607454]). The dividend will be payable on April 1, 2022, to stockholders of record on March 1, 2022.

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Lupin Signs Promotional Agreement with Exeltis on SOLOSEC® expanding access for Adult Women Suffering with Bacterial Vaginosis and Adults with Trichomoniasis

On January 27, 2022 Lupin Pharmaceuticals Inc., (Lupin) and Exeltis USA Inc. reported a promotional agreement for Exeltis to promote SOLOSEC along with Exeltis’ existing line of Women’s Health products, further enhancing value to OBGYNs and their patients (Press release, Lupin, JAN 27, 2022, View Source [SID1234607606]). SOLOSEC is indicated for the treatment of Bacterial Vaginosis in adult women (a common vaginal infection) and Trichomoniasis in adults (the most common non-viral, curable sexually transmitted infection in the U.S.).1-4

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"This partnership will expand the reach of SOLOSEC, allowing more Healthcare Providers to be aware of the benefits of SOLOSEC, and increase access for adult women suffering with bacterial vaginosis and adults with trichomoniasis," said Vinita Gupta, Chief Executive Officer of Lupin "We are extremely excited to partner with Exeltis." Salustiano Perez, Chief Executive Officer of Exeltis added, "Our team is thrilled to embark on this partnership. The addition of Solosec fits precisely within our current portfolio of products, enhancing our commercial strategy, and offering numerous solutions to our customers and their patients".

About SOLOSEC

SOLOSEC (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in adult women and trichomoniasis, a sexually transmitted infection, in adults.1-4 SOLOSEC is designed to be easy to take and one oral dose contains a complete course of treatment.1

Additional information about SOLOSEC can be found at www.SOLOSEC.com.

INDICATION

SOLOSEC (secnidazole) 2 g oral granules is an antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women and trichomoniasis in adults. Since trichomoniasis is a sexually transmitted disease, treat sexual partners of infected patients with the same dose and at the same time to prevent reinfection.

DOSAGE AND ADMINISTRATION

SOLOSEC is a single-dose therapy for oral use. The entire contents of SOLOSEC packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC is not intended to be dissolved in any liquid. Avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC and for at least 2 days after completing therapy.

IMPORTANT SAFETY INFORMATION

SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole or other nitroimidazole derivatives.
Vulvovaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
Potential risk of carcinogenicity is unknown and has not been studied in patients. Carcinogenicity has been seen in rodents chronically treated with nitroimidazole derivatives, which are structurally related to secnidazole. Chronic use should be avoided.
Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
Most common adverse reactions observed in clinical trials (incidence ≥2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Important Safety Information.

Or

Please click here for full Prescribing Information.

Manufactured for and Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202

Marketed by: Exeltis USA, Inc., Florham Park, NJ 07932

SOLOSEC is a registered trademark owned by Lupin Inc.

Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management’s expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.

Ostentus Therapeutics, Inc., and City of Hope to Initiate Studies of Novel OST Natural Products for Treatment of Leukemia and Other Cancers

On January 27, 2022 Ostentus Therapeutics, Inc., reported that it has entered into a Sponsored Research Agreement with City of Hope, a world-renowned cancer treatment and research organization and a National Cancer Institute-designated Comprehensive Cancer Center, to conduct preclinical research on OST compounds, which could be used as future therapies for leukemia and other cancers (Press release, City of Hope, JAN 27, 2022, View Source [SID1234607455]).

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"Ostentus is honored to work with City of Hope and Dr. Marcucci on this exciting new phase in the journey of bringing OST proprietary compounds to the market as a potential anti-cancer therapy"

OST compounds are natural products derived from plants native of tropical and subtropical America, which have been used in alternative and traditional medicine. At City of Hope, these compounds will undergo rigorous pharmacologic and toxicologic testing at specialized laboratories. The compounds’ active principles will be investigated individually and in combination to identify their mechanisms of action and anticancer activity.

Guido Marcucci, M.D., director of City of Hope’s Gehr Family Center for Leukemia Research, Chair of the Department of Hematologic Malignancies Translational Science and Chief of its Division of Leukemia Research, will lead the research, which is expected to culminate into a first-in-human clinical trial.

"Ostentus is honored to work with City of Hope and Dr. Marcucci on this exciting new phase in the journey of bringing OST proprietary compounds to the market as a potential anti-cancer therapy," said Elisabetta Graff, Ostentus President and Chief Financial Officer.

"We look forward to working with Ostentus on this exciting preclinical project and the potential application of the OST natural products to our personalized therapeutic approaches for cancer and leukemia patients," Dr. Marcucci added.