HotSpot Therapeutics Closes $100M Series C to Advance First-in-Class Allosteric Drug Discovery Platform to the Clinic

On November 29, 2021 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of first-in-class allosteric therapies targeting regulatory sites on proteins referred to as "natural hotspots," reported the close of its oversubscribed $100 million Series C financing, bringing its total funding to $190 million (Press release, HotSpot Therapeutics, NOV 24, 2021, View Source [SID1234596182]).

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Led by Pivotal bioVenture Partners, with significant participation by LSP and B Capital Group, the round includes new investors Monashee Investment Management, LLC, CaaS Capital Management, Revelation Partners and Pavilion Capital, as well as participation from previous investors, Atlas Venture, Sofinnova Partners, SR One Capital Management, funds managed by Tekla Capital Management, LLC, and MRL Ventures Fund. Ash Khanna, PhD, of Pivotal bioVenture Partners, and Fouad Azzam, PhD, of LSP, will join the HotSpot Board of Directors.

The new financing will be used to continue advancing HotSpot’s Smart AllosteryTM platform, with a focus on undrugged and poorly druggable targets, as well as the company’s existing pipeline.

"With the support of top-tier healthcare and technology investors, we will expand on the significant productivity of the Smart Allostery platform to enable a treasure trove of sought-after disease targets and thereby develop medicines that broadly benefit patients," said Jonathan Montagu, Co-founder and Chief Executive Officer of HotSpot Therapeutics. "We have diligently established a deep pipeline of product opportunities in cancer and autoimmune disease, each offering a clear path to clinical value through precision and patient-targeted trial design."

HotSpot’s Smart AllosteryTM platform unlocks a vast range of disease-relevant proteins for the first time through the identification of protein pockets called "natural hotspots." Natural hotspots are pockets that are decisive in protein function yet previously unexploited using conventional allostery approaches. The Smart Allostery platform encompasses a broad suite of AI-enabled technologies and the industry’s largest and most diverse chemical library tailored to hotspots. The company is leveraging the Smart Allostery platform to uncover, capture, and drug natural hotspots across a wide array of disease-causing proteins.

"Within 36 months, HotSpot has established a new paradigm for allostery drug discovery that is reproducibly delivering small molecules across multiple target classes, including transcription factors and E3 ligases," said Ash Khanna, PhD, Venture Partner at Pivotal bioVenture Partners. "We are thrilled to be partnering with HotSpot as they advance their pipeline to the clinic and realize the promise of delivering potentially lifesaving therapeutics to patients."

Earlier this month, HotSpot announced new data validating its Smart AllosteryTM platform in the elucidation and preclinical evaluation of a novel allosteric inhibitor of the E3 ubiquitin ligase CBL-B, an important target in cancer immunotherapy. The data show successful targeting with the first and only selective small molecule inhibitors of CBL-B. Identified via the company’s Smart AllosteryTM platform, these small molecules promote T cell responses in vitro and in mice. Through allosteric inhibition of this negative regulator of immune cells, HotSpot’s small molecule CBL-B inhibitors offer the potential for increased immunotherapy efficacy for cancer patient populations that have historically exhibited poor treatment responses.

Allarity Therapeutics A/S Publishes Offer Document Offering to Acquire Company Shares in Exchange for Shares in Allarity Therapeutics, Inc. with the Intent to Complete Recapitalization

On November 24, 2021 Allarity Therapeutics A/S ("Allarity A/S" or the "Company") reported a voluntary offer and offer document to the shareholders of Allarity A/S to acquire all shares in Allarity A/S (the "Offer"), with the intent of completing the Company’s recapitalization and reorganization ("Recapitalization") into a US holding company (Allarity Therapeutics, Inc., a Delaware corporation, hereinafter "Allarity Delaware") and listing on the US Nasdaq Stock Market, as initially announced on May 21, 2021 and approved by the shareholders at the extraordinary general meeting on November 22, 2021 (Press release, Allarity Therapeutics, NOV 24, 2021, View Source [SID1234596083]).

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The Tender Period commences on November 25, 2021, and expires on December 9, 2021, at 3:00 pm CET. The Tender Period may be extended by the Board of Directors at its discretion. Settlement is expected to commence on or around December 20, 2021. Allarity A/S has reserved the right to extend the acceptance period for the Offer and to postpone the settlement date.

Summary

The Board of Directors of Allarity A/S unanimously recommends the Company’s shareholders to accept the Offer.
The Offer is being made in connection with the Company’s recapitalization and reorganization into a US holding company, approved by unanimous vote at the Company’s extraordinary general meeting held on November 22, 2021, in order to effect the Company’s migration to the U.S. Nasdaq stock market.
Shareholders in Allarity A/S are being offered the opportunity to swap their existing shares for shares in Allarity Delaware which is currently a wholly-owned subsidiary of Allarity A/S.
Shareholders in Allarity A/S that accept the Offer will receive shares in Allarity Delaware in relation to their existing holding in Allarity A/S, where fifty (50) existing Allarity A/S held shares entitle accepting shareholders to one (1) new share in Allarity Delaware (the "Exchange Ratio").
In the event that the holding is not exactly divisible by fifty (50), the Offer will result in fractional shares. Such fractional shares cannot be validly issued under US law and will therefore be settled in cash.
After having accepted the Offer, shareholders’ nominees (bank, custodian, or other broker) will receive the tradeable US shares on shareholders’ behalf, and thereafter shareholders will be able to trade these new shares on US Nasdaq through each shareholder’s nominee. The immediate availability to trade and transact on your new Allarity Delaware shares may depend on how your nominee (bank, custodian, or other broker) elects to receive such new shares.
Allarity A/S shareholders who participate in the Offer will, as of the completion of the Recapitalization, own the same percentage of Allarity Delaware as they did in Allarity A/S prior to the Recapitalization, subject only to adjustments due to cash compensation being made with regard to fractional shares if any, and subject to ownership dilution due to the announced investment from 3i LP.
The Offer will be completed through one capital decrease of nominal DKK 11,873,736 and up to eight capital decreases of nominal DKK 989,478 each in Allarity A/S down to nominal DKK 400,000.
In the event that not all shareholders sell their Shares to Allarity A/S in the Offer, the remaining shares in Allarity Delaware are expected to be distributed to such shareholders as dividends or as liquidation proceeds in connection with the liquidation of Allarity A/S. Any such distributions may be subject to withholding taxes as applicable.
It is a condition for the acceptance of the Offer that the individual shareholder offers all shares held by the shareholder during the Tender Period. Hence, partial participation in the Offer is not possible.
Steve Carchedi, CEO of Allarity A/S, commented: "We have come a long way since this Company began humbly, more than a decade ago, as a small start-up outside of Copenhagen, Denmark. Now, we stand ready to take a quantum leap forward by migrating onto the US NASDAQ and realizing our true potential. Our Board of Directors, together with our executive management team, universally support this transformative migration of our Company to the US NASDAQ. We believe that this move is not only in the best interests of our shareholders and our Company, but is crucial and necessary for our achievement of Allarity’s vision to realize the promise of personalized cancer care by bringing our novel therapeutics and DRP companion diagnostics to market and to cancer patients."

Further information

For further information about the Offer is available in the Offer Document which is available for download; please visit: www.allarity.com/offer.

The rationale for the proposed combination

The purpose of the recapitalization and reorganization is to enable the Company to further its mission of facilitating personalized medicine for cancer patients through advancing its pipeline programs and DRP companion diagnostics. It is expected that the change of marketplace will enhance the Company’s ability to achieve market values more in line with its US Nasdaq listed peer group and secure the necessary financing for its future success, with greater participation by institutional investors who primarily invest in US listed companies. The USD 20,000,000 investment is subject to, inter alia, a listing of the shares of Allarity Delaware on the US Nasdaq Stock Market.

Background for the Offer

On May 21, 2021 Allarity A/S announced that it has entered into an agreement with 3i LP, a U.S. fund formed under a single family office umbrella investing in public companies, for a USD 20,000,000 investment (the "Securities Purchase Agreement") to support Allarity A/S’ recapitalization and reorganization into Allarity Delaware and an application for listing on the U.S. Nasdaq Stock Market. The USD 20,000,000 investment will be made directly into Allarity Delaware and was subject to, inter alia, completion of the Reorganization and a listing of the Delaware Common Stock on the U.S. Nasdaq Stock Market. Shareholders of Allarity A/S approved the investment by 3i LP and the Reorganization Agreement at the extraordinary general meeting held on November 22, 2021.

Allarity Delaware has initially been organized as a wholly owned subsidiary of Allarity A/S and as of the date of this Offer Document has no business operations or assets and has engaged in no commercial activities other than pursuing the Reorganization described herein and in the information statement/prospectus.

Simultaneously with the execution of the Securities Purchase Agreement, Allarity A/S has entered into a Plan of Reorganization and Asset Purchase Agreement with Allarity Delaware to facilitate Allarity Delaware becoming a U.S. holding company listed on the U.S. Nasdaq Stock Market (the "Reorganization Agreement"). As of November 25, 2021, Allarity Delaware purchased, indirectly through a special purpose wholly owned subsidiary, all of the assets and assumed substantially all of the liabilities of Allarity A/S in exchange for shares of common stock in Allarity Delaware, for which an application for trading on the U.S. Nasdaq Stock Market has been made to be effective on completion of the Recapitalization. The purchase is conditional upon completion of the Recapitalization Agreement.

In connection with receipt by Allarity A/S of the Delaware Common Stock, Allarity A/S is, by way of publication of this Offer Document, commencing a share swap program offering the shareholders of Allarity A/S to exchange their shares in Allarity A/S with Allarity Delaware common stock on the basis of the Exchange Ratio. In the event that not all shareholders exchange their Shares to Allarity A/S in the Offer the remaining Delaware Common Stock are expected to be distributed to such shareholders as dividends or as liquidation proceeds in connection with a liquidation of Allarity A/S. Withholding taxes may apply to such distributions and will be deducted accordingly.

As a result of the Recapitalization, Allarity Delaware will become the direct or indirect holder of all of the assets and substantially all of the liabilities formerly held by Allarity A/S, except for the shareholding in Allarity Delaware and a certain level cash position to defray running costs also related to liquidation. Allarity A/S’ shareholders who participate in the Offer will, as of the completion of the Recapitalization, own the same percentage of Allarity Delaware as they did in Allarity A/S prior to the Recapitalization, subject only to adjustments due to cash compensation being made with regard to fractional shares, if any, and subject to ownership dilution due to the announced investment from 3i LP.

Upon the completion of the Recapitalization, 3i LP will invest USD 20,000,000 in Allarity Delaware in exchange for convertible preferred stock in Allarity Delaware at an initial fixed conversion price of USD 9.906, which, if fully converted, would be convertible into a 20% ownership of the Allarity Delaware shares of common stock over time, subject to the condition that 3i may not beneficially own more than 4.99% of Allarity Delaware shares of common stock at any point in time. There is an implied pre-investment value for Allarity Delaware of USD 80,000,000 and a post-investment implied value of USD 100,000,000 assuming that the Recapitalization is completed and that Allarity Delaware is listed on the U.S. Nasdaq Stock Market.

It is the belief of the Board of Directors that the Reorganization, the listing of Allarity Delaware on the U.S. Nasdaq Stock Market and completion of the 3i LP investment will secure necessary working capital, give better access to future capital, unlock the true value of the Company, and in the end increase the value for the shareholders in a more liquid and accessible market. For further information on the reasons behind the Reorganization please see pages 7 and 8 of the Registration Statement.

Grant of New Warrants and Resolutions on Existing Warrants

On November 24, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that the Board of Directors of Allarity has exercised the authorization granted by the shareholders at the Extraordinary General Meeting held on November 22, 2021, to issue new warrants (Press release, Allarity Therapeutics, NOV 24, 2021, View Source [SID1234596082]). The Board has resolved to grant a total of 51,292,653 warrants as a part of a new incentive program for the Board of Directors, employees and consultants in Allarity. All warrants are issued free of charge and are issued to ensure alignment of interests between the Company’s employees, management, Board of Directors, and shareholders as the Company completes its recapitalization, restructuring, and migration to the U.S. Nasdaq stock market.

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The 51,292,653 warrants to employees, consultants and board members of the company are granted as follows:

46,608,675 warrants are granted to the employees of Company, including executive management, and a consultant
4,683,978 warrants are granted to members of the Board of Directors
Each warrant confers the right to subscribe for one share of nominal DKK 0.05 in Allarity Therapeutics A/S at the following exercise prices:

For 38,807,413 warrants, the exercise price for each warrant is SEK 0.945 (Grant 1)
For 7,801,262 warrants, the exercise price for each warrant is SEK 1.592 (Grant 2)
For 4,683,978 warrants, the exercise price for each warrant is SEK 1.85 (Grant 3)

By application of the Black-Scholes formula, the aggregate fair value of the issued warrants subject to Grant 1, Grant 2 and Grant 3 can be calculated as USD $5,143,821, USD $1,034,037 and USD $620,849 (corresponding to DKK 34,172,459, DKK 6,869,520 and DKK 4,124,548), respectively.

Additional terms and conditions applicable to the issued warrants are set forth in appendix 14 to the articles of association of Allarity Therapeutics A/S, provided, however, that 38,807,413 warrants to the employees, including executive management, and consultant shall vest with 25% on the grant date and hereafter with 1/36 per month calculated from 7 July 2021, and that 4,683,978 warrants to the board members shall vest with 25% on the grant date and hereafter with 1/48 per month calculated from 24 November, 2021. A further 7,801,262 warrants shall be deemed fully vested at the time of issuance.

In addition to the above the Board of Directors has with regard to existing outstanding warrants resolved that

With respect to 3,996,864 warrants issued on the terms and conditions set out in Appendix 8 to the articles of association, the Board of Directors has pursuant to clause 5 of Appendix 8 resolved that the warrants may be exercised in an extraordinary exercise window in the period 23 November – 8 December 2021. If these warrants are exercised fully, Allarity A/S will receive SEK 13,189,651 in cash proceeds and the warrants will be replaced with 79,937 Delaware Common Stock by applying an exchange ratio corresponding 3,996,864 divided by 50. In the event that these warrants are not exercised these warrants will lapse and become null and void.
The board of directors has resolved that 4,287,381 existing warrants with an exercise price of SEK 2.20 per Share in connection with the Reorganization Exchange Agreement shall be converted into similar instruments of similar value in Allarity Therapeutics Inc.
The Board of Directors has resolved that 1,980,000 existing warrants with an exercise price of SEK 1.41 per Share in connection with the Reorganization Exchange Agreement shall be converted into similar instruments of similar value in Allarity Therapeutics Inc.
The Board of Directors has resolved that 1,409,555 existing warrants with an exercise price of SEK 2.42 per Share in connection with the Reorganization Exchange Agreement shall be converted into similar instruments of similar value in Allarity Therapeutics Inc.

RedHill Biopharma to Host Third Quarter 2021 Financial Results and Operational Highlights Webcast on November 30, 2021

On November 24, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it will report its third quarter 2021 financial results and operational highlights on Tuesday, November 30, 2021 (Press release, RedHill Biopharma, NOV 24, 2021, View Source [SID1234596048]).

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The Company will host a webcast on Tuesday, November 30, 2021, at 8:30 a.m. EST, during which it will present key highlights for the third quarter of 2021.

The webcast including slides will be broadcast live on the Company’s website, View Source, and will be available for replay for 30 days.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel:
+972-3-530-8845; the access code for the call is: 9753927 .

Aura Biosciences Reports Third Quarter 2021 Financial Results and Provides Clinical Development and Operational Highlights

On November 24, 2021 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications including ocular and urologic cancers, reported financial results for the third quarter ended September 30, 2021 (Press release, Aura Biosciences, NOV 24, 2021, View Source [SID1234596046]).

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"We recently completed a successful initial public offering, placing us in a solid financial position to advance our lead VDC, AU-011, through pivotal development for our first indication in the ocular oncology franchise," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "We are very encouraged with the final data from the Phase 1b/2 trial with intravitreal administration that was presented by Dr. Carol Shields at the AAO annual meeting last week, as well as the continued favorable safety and tolerability profile of the ongoing Phase 2 study with suprachoroidal administration. These data support our plan to move into the pivotal program in 2022 with the goal to develop the first targeted therapy for patients with indeterminate lesions and small choroidal melanoma.

Dr. Pinos continued: "We are also excited to work toward unlocking the broad oncology potential of the VDC platform and plan to initiate clinical development in non-muscle invasive bladder cancer during the second half of next year. Supporting the advancement of our programs, we have a robust balance sheet and a strong team, which we recently built out with several key additions to our management team and Board of Directors."

Recent Pipeline Developments

AU-011 is being developed for the first line treatment of indeterminate lesions and small choroidal melanoma, a life threatening and rare disease with no approved drugs. Data from two clinical trials were recently presented at the American Academy of Ophthalmology (AAO) 2021 Annual Meeting.
Final Phase 1b/2 Data with Intravitreal (IVT) Administration. Data from the completed Phase 1b/2 trial using IVT administration were presented by Dr. Carol Shields, Director, Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. The data demonstrated a statistically significant reduction in tumor growth rate (-0.483 mm/yr, p = 0.018), a 64% tumor control rate, and a visual acuity preservation rate of 71%, which is a dramatic improvement compared to the current standard of care with radiotherapy. These three endpoints have been agreed upon with FDA and will be used in the pivotal program.
Interim Phase 2 Safety Data with Suprachoroidal (SC) Administration. Preliminary results presented by Dr. Hakan Demirci, Professor of Ophthalmology at Kellogg Eye Center, University of Michigan, demonstrate a favorable safety and tolerability profile for AU-011 with SC administration. The data showed no treatment-related serious adverse events, dose limiting toxicities, or grade 3/4 adverse events. Aura plans to present 6-12 months safety and efficacy data from this trial in 2022.
Aura plans to select the route of administration and treatment regimen to initiate the pivotal program in the second half of 2022.
Leveraging the broad tumor targeting capabilities of the VDC platform, Aura is planning to pursue clinical development of AU-011 in non-muscle invasive bladder cancer (NMIBC).
NMIBC is an area of high unmet need with no approved targeted therapies. The AU-011 mechanism of action supports the opportunity for use as a first-line treatment either following initial diagnosis and/or Bacillus Calmette-Guerin, BCG, refractory disease. The data from preclinical Investigational New Drug (IND)-enabling studies of AU-011 demonstrated robust efficacy, supporting its clinical development as a single agent or in combination with checkpoint inhibitors. The planned Phase 1a trial will evaluate the safety and early proof of mechanism in the setting, exploring local necrosis and evidence of immune activation, and Aura expects to initiate the trial in the second half of 2022.
Recent Corporate Updates

Completed Initial Public Offering (IPO). In November 2021, Aura closed a successful IPO of 6,210,000 shares of its common stock, which included the full exercise of the underwriters’ option, at a public offering price of $14.00 per share. The aggregate gross proceeds to Aura from the IPO were approximately $86.9 million, before deducting underwriting discounts and commissions and other estimated offering expenses. Aura’s common stock commenced trading on the Nasdaq Global Market on October 29, 2021 under the ticker symbol "AURA".
Antony Mattessich Appointed to the Board of Directors in September 2021. Mr. Mattessich is currently the Chief Executive Officer at Ocular Therapeutix. Prior to Ocular Therapeutix, he was Managing Director of Mundipharma International, based in Cambridge, England. Prior to his time at Mundipharma, Mr. Mattessich ran the U.S. respiratory, dermatology and pediatrics group at Novartis.
Chris Primiano, J.D., Appointed Chief Business Officer in September 2021. Mr. Primiano joined Aura from Karyopharm Therapeutics Inc., where he most recently served as Executive Vice President, Chief Business Officer, General Counsel and Secretary. Mr. Primiano played an important role in transitioning Karyopharm Therapeutics Inc. from 40 employees in a preclinical and early clinical development setting to 400 employees, commercializing XPOVIO (selinexor) across multiple indications.
Third Quarter 2021 Financial Results

As of September 30, 2021, Aura had cash and cash equivalents totaling $81.8 million. Aura raised $86.9 million in gross proceeds from the IPO. Aura believes its current cash and cash equivalents are sufficient to fund the Company’s operations into 2024.
Research and development expenses increased to $6.4 million for the three months ended September 30, 2021 from $2.9 million for the three months ended September 30, 2020, primarily due to progression of clinical trials and ongoing manufacturing development costs for AU-011. In addition, research and development expenses related to personnel increased from growing headcount due to the progression of clinical trials.
General and administrative expenses increased to $2.5 million for the three months ended September 30, 2021 from $0.8 million for the three months ended September 30, 2020. General and administrative expenses include $0.4 million and $0.1 million of stock-based compensation for the three months ended September 30, 2021 and 2020, respectively. The increase was primarily related to an increase in personnel expenses due to an increase in headcount, as well as general increases in audit, legal, consulting and facilities expenses in anticipation of becoming a public company.
Net loss for the three months ended September 30, 2021, was $8.8 million, compared to $3.6 million for the three months ended September 30, 2020.